Drugs, Health Technologies, Health Systems
Key Messages
What Is the 2026 Watch List?
The Watch List is an annual Horizon Scan report from Canada’s Drug Agency that highlights emerging health technologies and issues that could shape the future of health care in Canada.
The 2026 Watch List focuses on regenerative medicine. It is organized into 2 parts — 5 regenerative medicine technology platforms and 5 related issues that are expected to meaningfully influence health systems in Canada over the next 5 years.
Why Is This Important?
Regenerative medicine is a rapidly advancing, multidisciplinary field focused on repairing, replacing, or regenerating damaged cells, tissues, and organs. Through advances in gene editing, stem cell therapy, tissue engineering, and other emerging approaches, regenerative medicine has the potential to shift the goals of therapy from symptom management to restoring biological function, which could transform care options for patients and support broader health systems and societal benefits.
Canada has made major contributions to regenerative medicine innovation, yet many regenerative medicine technologies, including those developed in Canada, are not currently easy to access within our health systems. To fully realize the potential of regenerative medicine in patient care, emerging advances in the field need to be identified, along with implementation barriers from across the entire product life cycle.
How Was the Watch List Developed?
The project was informed by an advisory group of experts in regenerative medicine including 1 patient partner who provided guidance and input at key points throughout the project.
A 25-item list was generated through a literature search of published medical literature, supplemental informal web searching for news articles and industry reports, and expert input. We included specific examples of relevant technologies, ongoing clinical studies, or other initiatives to demonstrate how each item is being explored in practice.
A diverse group of 20 multidisciplinary participants from across Canada, with experience and expertise in regenerative medicine, developed the 2026 Watch List by reviewing the 25-item list and selecting the top items through consensus-based decision-making using a modified James Lind Alliance priority-setting approach during a half-day virtual workshop.
The examples provided for each technology platform are used to support understanding, are not exhaustive, and do not represent endorsement by Canada’s Drug Agency.
What Is the Potential Impact?
By highlighting these emerging technology platforms and related issues early, this Watch List is intended to support health care decision-makers in anticipating system-level changes needed to implement regenerative medicine across Canada and shape how its potential benefits could be realized by patients, clinicians, and health systems.
CAR
chimeric antigen receptor
CDA-AMC
Canada’s Drug Agency
iPSC
induced pluripotent stem cell
JLA
James Lind Alliance
Through horizon scanning, we identify new and emerging technologies that have the potential to impact health care systems in Canada. This work supports decision-makers by providing a summary of emerging health technologies and their related issues, helping them consider implementation and prepare for potential wider adoption of these innovations.
Canada’s Drug Agency (CDA-AMC) releases an annual Watch List to identify technologies that have the most potential to transform health systems and shape the future of health care in Canada. This annual list signals how technology innovations may affect future health system needs and provides early assessments to help guide health system planning. In recent years, the Watch List has explored themes such as precision medicine,1 caring for children and youth with medical complexity,2 and artificial intelligence in health care.3 The focus of the 2026 Watch List is regenerative medicine.
Regenerative medicine is the branch of medicine that develops methods to regrow, repair, or replace damaged or diseased cells, organs, or tissues. Regenerative medicine includes the generation and use of therapeutic stem cells, tissue engineering, and the production of artificial organs.4
The goal of regenerative medicine is to restore functional capacity by stimulating or replicating the body’s own repair mechanisms or through external therapeutic strategies, such as stem cell therapies, gene therapies, tissue-engineered constructs (e.g., organs or tissues), and cell-free regenerative products.5
The field is interdisciplinary, integrating advances in cellular and molecular biology, biomaterials science, bioengineering, pharmacology, and biochemistry to create novel therapies.6 Regenerative medicine is also shaped by a global scientific community, where international collaboration and innovation influence how therapies are developed and brought into clinical practice worldwide.
Canada has a long-standing legacy in regenerative medicine, beginning with the landmark discovery of hematopoietic stem cells in 1961 by James Till and Ernest McCulloch, a breakthrough that helped launch the modern field of stem cell science.7 Since then, Canada has built an ecosystem of universities, research institutes, public-private partnerships, dedicated funding programs, and pan-Canadian networks that foster multidisciplinary collaboration and support the development and commercialization of regenerative medicine products.8,9 Drawing on decades of expertise, public and private investment, and a growing research and manufacturing infrastructure, Canada is well placed to continue to be a global leader in advancing regenerative medicine from discovery to clinical implementation.
Regenerative medicine has the potential to fundamentally redefine the goals of therapy across a broad range of medical conditions. For many diseases and neurologic, cardiovascular, and metabolic disorders, current treatments primarily focus on managing symptoms and slowing progression rather than addressing the underlying pathology.10-12 Regenerative approaches represent a paradigm shift, aiming to develop curative therapies that can repair, replace, or restore damaged cells, tissues, and organs by stimulating or replicating the body’s natural ability for self-repair. These strategies could improve patient care by restoring function, reducing disease burden, and potentially improving quality of life.13
Realizing this promise requires addressing issues for Canada’s health systems and the patients they serve. Regenerative medicine therapies are complex, often combining living cells, biological molecules, and synthetic materials. Their production and administration require specialized infrastructure and highly trained personnel. Unlike traditional small molecule therapies, regenerative treatments are often personalized, tailored to an individual’s unique biological characteristics or developed using the patient’s own cells to provide more precise and individualized treatment. This personalization also introduces new challenges for how these therapies are developed, evaluated, regulated, and integrated into clinical practice.
Within Canada’s innovation landscape, the regenerative medicine industry may represent both a scientific opportunity and a potential source of economic growth. Sustained support for innovations in this sector could:
create high-skill jobs across research, biomanufacturing, and health care delivery
strengthen domestic innovation capacity and international competitiveness
help translate research into health and economic benefits.9,14,15
The 2026 Watch List highlights the top 10 emerging technology platforms and issues in regenerative medicine that are expected to have significant and meaningful impact on health care systems in Canada over the next 5 years. In this context, issues refer to cross-cutting considerations (e.g., clinical, health systems planning, social, economic, environmental, ethical, legal, or regulatory) that may affect how regenerative medicine technologies are developed, adopted, or used in Canada.
This report aims to help decision-makers anticipate both the opportunities and the system-level challenges these innovations may bring. It also serves as a guide to separate the true potential and promise of regenerative medicine from the surrounding hype and speculation. The report describes key considerations for implementation and identifies overarching issues that could influence adoption and inform health systems planning. The 5-year horizon reflects the rapid pace of innovation in the field and focuses on technologies that are further along in the research phase or show strong potential for adoption in Canada or similar health care systems.
To develop the 2026 Watch List, CDA-AMC collaborated with an external advisory group and convened a half-day virtual workshop in October 2025 (refer to Appendix 1 for detailed information about the Advisory Group members and workshop participants). The Advisory Group included 5 experts in regenerative medicine, each bringing a distinct perspective informed by their experience as a patient, clinician, researcher, or policy expert. Their role included validating key definitions, providing input on our approach, and reviewing the draft version of this report.
Early in the process, the Advisory Group agreed that the Watch List should focus on broader technology platforms rather than individual products. Technology platforms refer to overarching therapeutic approaches, modalities, or methods that can be used to develop many different types of products. This focus reflects both the broad range of emerging regenerative medicine products and the rapid pace at which the field is advancing.
Using a literature search of published medical literature (described in Appendix 3), as well as a supplemental informal web search for news articles and industry reports, the project team drafted a comprehensive list of 25 items. These items included both emerging regenerative medicine technology platforms and related issues with the potential to substantially impact health care delivery and planning in Canada over the next 5 years. This list was verified for accuracy and comprehensiveness through discussion and feedback from the Advisory Group.
The 25-item list was circulated to the workshop participants. The participants represented diverse views and experiences, and included patient partners, policy experts, researchers, members of industry, innovators, and clinicians from across Canada. Although we aimed to have representation from every province and territory, we were unable to recruit participants from Prince Edward Island, Yukon, Northwest Territories, and Nunavut.
During the workshop, participants used a consensus-based decision-making process to select the final items for inclusion in the 2026 Watch List. CDA-AMC has a partnership with the James Lind Alliance (JLA), which supports patients, caregivers, and clinicians in identifying and prioritizing important health research questions. The 2026 Watch List was developed using a modified JLA priority-setting approach.16 Further details about the process used to identify and select items for inclusion are described in Appendix 2.
The outcome of this process is a Watch List of the top 5 regenerative medicine technology platforms and top 5 related issues that reflects the diverse values, experiences, and perspectives of the contributors engaged throughout the project. Although specific examples of technologies, ongoing clinical studies, and other initiatives are provided to illustrate the items in practice, these examples are intended for general awareness, are not exhaustive, and do not represent endorsements by CDA-AMC.
The workshop participants agreed that all 25 identified items, particularly the issues, were important, and that narrowing them down to a final list was difficult. Items that did not make the final list are included in Appendix 4. Items are numbered but are not ranked; the fifth item is just as important as the first.
The immune system is the body’s built-in defence network that protects against pathogens, such as viruses, bacteria, and parasites, as well as foreign or abnormal cells, such as cancer. It includes several types of specialized cells that work together to keep the body healthy. Innate immune cells include phagocytes, dendritic cells, natural killer cells; adaptive immune cells include B lymphocytes and T lymphocytes.17 The innate immune system provides fast, nonspecific protection, while the adaptive immune system generates specific responses to antigens through specialized receptors and retains memory of previous encounters, allowing it to respond more rapidly and precisely if the same antigens appear again.18
Despite the immune system’s natural capacity to provide protection, there are some diseases that can evade or disrupt its activity, such as cancer or autoimmune conditions. Existing treatments (e.g., chemotherapy, radiation, or immunosuppressive drugs) can help manage these conditions but often fall short of providing a cure and may cause severe side effects.19,20 These challenges have prompted growing interest in therapies that harness and enhance the body’s own immune defences. Among the most promising are adoptive cell therapies, an emerging class of immunotherapy.21,22
Adoptive cell therapies are a type of cellular immunotherapy in which a patient’s own immune cells (or cells from a donor) are collected, modified in a laboratory, and infused back into the patient to help fight disease.23
Specific adoptive cell therapy modalities being investigated for potential applications in cancer and other conditions include chimeric antigen receptor (CAR) T-cell therapy, T-cell receptor therapy, and tumour-infiltrating lymphocyte therapy.24
Some adoptive cell therapies have been in use for decades, particularly for hematologic cancers. Ongoing research is expanding their use to solid tumours, infectious diseases, and autoimmune conditions. Some also have the potential to enhance immune tolerance and help treat viral infections in patients undergoing organ transplantation.25-29
Advances in cell engineering and manufacturing may enable the development of “off-the-shelf” allogenic (donor-derived) products, which could improve accessibility and scalability.27,30 To help address current access barriers, BioCanRx is developing a made-in-Canada, point-of-care manufacturing method that enables decentralized production of CAR T-cell therapies.31 BioCanRx is a network of researchers, partners, and interest holders working to advance immuno-oncology research and translation with the aim to turn all cancers into curable diseases.
The Ottawa Hospital, BioCanRx, and BC Cancer are expanding access to CAR T-cell therapy through the Canadian-Led Immunotherapies in Cancer-01 (CLIC-01) clinical trial, which is testing the first made-in-Canada CAR T-cell therapy (NCT03765177).32,33 In this approach, a patient’s T cells are collected and genetically modified to recognize and attack cancer cells that express the CD19 protein. Researchers are evaluating this therapy’s potential to treat certain hematologic cancers.
The National Research Council of Canada is developing a CAR T-cell therapy that targets the CD22 protein on cancer cells, which could be used when treatments targeting other cancer proteins, such as CD19, have not worked.34 This therapy is being tested in a clinical trial conducted as part of the Canadian-Led Immunotherapies in Cancer program (NCT06208735).35,36
An ongoing, multicentre, international clinical trial is evaluating the efficacy and safety of an investigational CAR T-cell therapy for active systemic lupus erythematosus in patients aged 16 years and older (NCT07015983).37
Once infused, the cells can expand and persist in the patient’s body, maintaining activity against target cells. This prolonged immune response may result in long-lasting benefits that could be curative for some conditions.38,39
Adoptive cell therapies could lead to improved safety outcomes by targeting disease-causing cells more precisely while leaving most healthy cells unharmed unlike conventional treatments such as chemotherapy or radiation that affect the whole body and can cause side effects.40
The development of new adoptive cell therapy approaches, including point-of-care manufacturing, could help make these treatments more affordable (i.e., by reducing shipping and storage costs) and improve access (e.g., improved wait times) across health care systems as part of broader efforts that also consider health system capacity constraints.41-43
Workshop participants expressed strong enthusiasm for adoptive cell therapies. Overall, participants agreed that adoptive cell therapies are already demonstrating real-world impact in oncology and could expand to new indications, including fibrotic and other types of diseases, highlighting their growing relevance within regenerative medicine. In particular, CAR T-cell therapies were recognized for their potential to deliver meaningful benefits to patients and health systems within the next 5 years.
Participants noted that investment in this area continues to support innovation in Canada and the development of new ideas and technologies. There was also some discussion of emerging adoptive cell therapy approaches that show promise for the treatment of certain solid tumours, such as tumour-infiltrating lymphocyte therapies.
The skin is the body’s largest organ, with a surface area between 1.5 m2 and 2 m2 in adults, and accounting for approximately 15% of total body weight.44,45 It serves as a physical barrier against the environment, protecting the body from pathogens, UV light, chemicals, and mechanical injury, while also regulating body temperature, preventing water loss, and supporting sensory function.
Structurally, the skin is made of multiple layers of cells and tissue, primarily organized into the epidermis, dermis, and hypodermis.46 A wide range of conditions can impair skin integrity, including
severe burns
large or chronic wounds
traumatic injuries
infections
congenital disorders
surgical procedures for cancer.
If the skin is extensively damaged or lost and cannot heal on its own, skin grafting may be required.47 The most common approach is autografting, in which healthy skin is harvested from an unaffected area of the patient’s body and transplanted to the injured site.48 Autografts eliminate the risk of immune rejection and have high rates of successful integration; however, they are limited by the amount of healthy skin available for harvest and can result in significant donor site morbidity (e.g., pain, scarring, infection).49
Grafts can also be obtained from donor tissue, known as allografting, to temporarily cover wounds until a permanent autograft can be performed. In 2020, tissue banks across Canada processed and released nearly 3,000 skin grafts for transplant.50 However, the availability of donor grafts is limited, and patient outcomes can vary depending on wound complexity, graft quality, and other factors.51
Advances in tissue engineering and materials science have allowed for the development of bioengineered skin that may help address some of the existing challenges.
Bioengineered skin refers to tissue constructs developed in laboratory settings using a patient’s own cells, donor cells, animal-derived grafts, or synthetic biomaterials. These products are used when there is insufficient healthy skin available for traditional autografting in individuals with severe wounds, burns, or congenital skin disorders.
Bioengineered skin constructs are designed to mimic key structural and functional characteristics of human skin to support healing and minimize scarring.52-54 Common biofabrication methods used to produce these constructs include electrospinning, moulding, and 3D printing.55 Ongoing research is also exploring strategies to improve the functionality of skin substitutes by:
strengthening mechanical properties such as elasticity52
incorporating various skin appendages (e.g., hair follicles, sweat glands, oil glands)56,57
adding melanocytes to better match patient-specific skin pigmentation and provide protection against UV rays.58
Self-assembled skin substitutes are autologous bilayered skin substitutes for burn wounds developed by the Quebec-based Laboratoire d’organogénèse expérimentale (LOEX).59 These are described as “self-assembled” because they are formed in laboratory conditions without a scaffold to provide structural support. An ongoing prospective clinical trial enrolling 17 participants from burn units across Canada is evaluating the product’s safety and efficacy over 36 months and comparing outcomes with split-thickness skin grafts.
DenovoSkin is a personalized, bioengineered human skin graft designed to treat wounds and burns. Findings from a recent phase I clinical trial with 10 pediatric participants demonstrated its potential use in reconstructive surgery for a number of conditions that require large skin grafts.60
Apligraf is a bilayered, living cell–based skin substitute designed to facilitate healing of venous leg ulcers and diabetic foot ulcers.61 It was the first true composite tissue analogue to become commercially available, and has been in clinical use for more than 25 years.62
StrataGraft is a bioengineered skin substitute used to treat deep thermal burns in adults who require surgical intervention. It facilitates healing by secreting human growth factors, cytokines, and extracellular matrix proteins that are involved in wound repair and regeneration.63
Bioengineered skin products could address donor shortages by reducing reliance on allografts.64
Engineered constructs may improve healing outcomes by supporting faster wound closure, improved vascularization, and reduced scarring.65
Larger or more complex wounds could be treated more effectively because laboratory-produced grafts can be better customized to match the shape and size of wounds.66
Autologous engineered skin substitutes could minimize the risk of immune rejection while avoiding the donor site morbidity associated with traditional autologous grafting.67
Workshop participants noted that bioengineered skin may have greater near-term impact compared to other more complex biofabricated organs (e.g., whole livers or hearts), which are probably still many years away from clinical implementation. Bioengineered skin products are already used in major burn centres across Canada, with recent clinical trial results increasing their potential for broader uptake.
Although some participants viewed bioengineered skin as a relatively narrow, single-organ application of tissue engineering, the group emphasized it is an important area to highlight because of its potential for near-term use in clinical care.
However, questions remain regarding scalability and manufacturing models. Participants wondered whether production will be centralized through commercial manufacturers or if manufacturing can be done through hospital-based, point-of-care approaches, and what the pathway to market would look like from the regulatory perspective.
Genes are the fundamental unit of inheritance, consisting of a segment of DNA that occupies a fixed position (locus) on a chromosome.
Some genes provide instructions to the human body for producing proteins. The structure and function of these proteins play vital roles in countless biological processes and have a direct influence on health. If a genetic variant occurs, it can disrupt protein production and lead to genetic diseases. The impact of these conditions often depends on the role of the affected protein and how essential it is for cellular processes and health.68
Genes also play a key role in the development and progression of many other noninherited diseases, including type 2 diabetes, heart disease, and cancer.69
Gene therapies are a promising avenue for treatment for people with rare diseases. Approximately 80% of rare diseases are caused by genetic changes, and many patients with these diseases currently have no effective treatment options.70 Because of the strong influence of genetics on human health, gene therapy is a promising approach to treat or ease the burden of many diseases and has the potential to significantly improve and extend many lives. Recent advances in gene delivery methods, therapeutic techniques, and clinical strategies for managing side effects have expanded the range of possible gene therapy applications.71
Gene therapies involve modifying a person’s genetic material to prevent or treat disease.72 This can involve replacing or altering a faulty gene with a healthy copy (gene editing), inactivating a gene that causes disease (gene suppression), or introducing a functional copy of a gene to restore function (gene addition).73
These therapies can be delivered outside the body (ex vivo, where cells are modified in a laboratory and then returned to the patient) or directly inside the body (in vivo, using a DNA nuclease and a gene delivery vector).74
Recent clinical trials have examined the use of gene therapies for many conditions, including genetic conditions caused by a single faulty gene (e.g., cystic fibrosis), cardiovascular conditions, and infectious diseases.75
Ex vivo gene delivery is being researched to promote bone regeneration, which can be applied in promoting the healing of bone fractures. In this method, a person’s cells are cultured and modified with gene therapy outside of the body and then added to the affected site, often using scaffolds (refer to Technology Platforms 5: Structural Scaffolds and Biomaterials for additional details). Another more streamlined ex vivo technique involves genetically modifying tissues (e.g., bone marrow, muscle, or fat) during surgery and reimplanting them into the affected area in a single procedure without the need for cell culture or scaffolds.76
Researchers are using clustered regularly interspaced short palindromic repeats (CRISPR)–based gene editing systems to correct genetic diseases.77 For example, a group of researchers recently developed a workflow for the rapid development of customized, corrective gene editing therapies for individuals with ultrarare or unique genetic variants.78 This approach was used to treat an infant with a life-threatening metabolic disorder who was too young to undergo a liver transplant. The experimental therapy successfully stabilized the child’s condition, and researchers are hopeful that this gene editing technique could be applied to genetically correct similar conditions.
Angiogenic gene therapies, which aim to promote the formation of new blood vessels, are undergoing research for the treatment of cardiac disorders. These therapies use a vector (a specialized gene delivery system) to transport therapeutic genes that prompt cells to produce and secrete angiogenic factors, such as vascular endothelial growth factors or fibroblastic growth factors. These growth factors stimulate the formation of new blood vessels. These approaches could provide a treatment option for ischemic heart disease.79
Gene therapies are being studied as potential treatments for type 1 diabetes, with approaches aimed at restoring insulin production by islet cells in the pancreas or protecting insulin-producing pancreatic beta cells from autoimmune attack.80 Gene therapies are also being explored to treat complications of diabetes beyond glycemic control, such as promoting angiogenesis to support wound healing in individuals with diabetic foot syndrome.81
Gene therapies could address unmet needs by providing options for conditions with limited or no effective treatments.82
Gene therapies could improve patient outcomes by offering long-lasting effects that, in some cases, could be curative.83
Delivering treatment early in patients’ lives may help prevent or limit the harm and progressive damage that would otherwise occur.84
Approaches that provide a cure or alleviate patients’ symptoms could ease the burden on individuals, families, and health care systems by reducing the need for ongoing medical resources and support. Adoption is potentially constrained by cost, infrastructure, and workforce demands.85
During the workshop, participants were eager about the advancements in gene therapy research, noting that these therapies have the potential to be life-changing for patients, especially those with rare diseases for which few effective treatments exist. However, participants remarked that more time is needed to understand the long-term safety and feasibility of gene therapies (for additional information, refer to Issue 1: Patient Safety and Risk of Harms).
Participants also expressed the following concerns:
the high cost of gene therapy, combined with the need for administration through specialized centres of excellence, could make these therapies complex and expensive to reimburse
gene therapies could increase demand on health care systems and resources because they often require specialized care and long-term patient monitoring
the geographic availability and costs associated with these therapies could limit access to certain patient groups and contribute to widening existing health inequities.
Many chronic and degenerative diseases cause progressive damage to the body by destroying or depleting the cells and tissues needed for proper function. Conditions such as heart failure, spinal cord injury, diabetes, and neurodegenerative disorders such as Parkinson disease can result in lasting damage because the body has a limited ability to replace or repair lost cells. Traditional treatments may help manage symptoms or slow disease progression, but they generally cannot restore the damaged tissue itself or reverse the underlying cause.86
To address this challenge, researchers are exploring regenerative approaches that aim to repair or replace cells that have been lost to disease.5 Stem cell–based therapies are at the forefront of this work. Although these have been used in medicine for decades, the field continues to evolve rapidly with new approaches and applications.87 By harnessing the natural capacity of stem cells to self-renew and develop into specialized cell types, these therapies hold the potential to restore function to damaged tissues and organs, offering a fundamentally different way of treating disease.
Stem cells are undifferentiated cells that can develop into various specialized cells and proliferate indefinitely to produce new cells (i.e., self-renewal). They are categorized based on their source (e.g., embryonic, adult, neonatal, induced pluripotent stem cells) and their potency, which refers to the number of different types of cells they can become: totipotent cells can form all cell types needed to form an organism (including tissues like the placenta), pluripotent cells can form any cell type in the body, multipotent cells can form several related cell types, and unipotent cells can produce only 1 cell type.88
A major advancement in the field occurred in 2012, when the Nobel Prize in Physiology or Medicine was awarded for the discovery of induced pluripotent stem cells (iPSCs). iPSCs are created by reprogramming mature somatic cells into a pluripotent state, giving them the ability to develop into almost any cell type. This breakthrough opened new possibilities for patient-specific therapies, with iPSC-based treatments now being evaluated in clinical trials for conditions such as hematologic malignancies, solid tumours, heart failure, Parkinson disease, and age-related macular degeneration.89
More broadly, stem cell–based approaches are being used to treat or prevent many conditions, including blood and immune system disorders, neurodegenerative conditions, cardiovascular disease, burn injuries, and autoimmune conditions.86
Stem cell–derived midbrain dopamine neuron cell therapy is being investigated in advanced Parkinson disease at Toronto Western Hospital (NCT04802733).90 Dopamine-producing neuron precursors are generated from embryonic stem cells and surgically implanted into the brain to replace neurons lost to disease. Findings from a first-in-human phase I clinical trial suggest that the therapy was generally well tolerated, although its efficacy is yet to be evaluated.91
Stem cell–derived islet replacement therapies are being developed for type 1 diabetes. In this approach, insulin-producing cells generated from stem cells are implanted into the body using different delivery methods, such as infusion into the hepatic portal vein or subcutaneous implantation using a protective encapsulation device. Once implanted, these cells can produce endogenous insulin and may lead to improved glycemic control.92-94
Retinal pigment epithelium derived from iPSCs is being investigated as a treatment for an advanced form of dry age-related macular degeneration (NCT04339764).95 This procedure involves harvesting cells from an individual’s blood and converting them to retinal pigment epithelium cells, which are then implanted in the eye through a small incision in the retina.95,96
Stem cell therapies could improve patient outcomes by replacing or repairing damaged cells and restoring organ or tissue function, These offer long-lasting treatment effects that address the root cause of disease rather than managing symptoms.97
For individuals with complex or degenerative conditions that have few effective treatments, stem cell approaches may improve their quality of life.98
Workshop participants noted that recent advances in iPSC research are expanding potential uses across a wide range of diseases, highlighting the platform’s importance for many patients. In addition to established uses, such as hematopoietic stem cell transplant for cancer, stem cells are increasingly being explored as tools to regenerate damaged tissues.
Participants specifically mentioned that stem cell–derived islet cell therapies are currently being evaluated in clinical trials for type 1 diabetes and may influence future treatment approaches. They described these therapies as likely to have a significant impact on provincial and territorial health care budgets, in part because patients will require long-term immunosuppression.
Participants noted that broader adoption of stem cell–based therapies could also reduce long-term health systems costs by decreasing the need for repeated interventions, hospitalization, and lifelong symptom management.
Tissue engineering is the application of methods and principles of engineering, medicine, biology, and physiology to build new functional tissues and organs to restore, maintain, or improve biological function.99
Achieving complex tissue-engineered structures requires more than just the right cell types — it requires replicating the structural and mechanical environment that cells naturally experience in the body. To do this, researchers combine living cells with biomaterials that mimic the natural extracellular matrix by providing structural support and creating a conducive environment for cell growth, maturation, and organization.100 These structural scaffolds play a fundamental role in tissue engineering because they provide mechanical support, allow perfusion of nutrients and oxygen, and transfer biochemical signals that modulate cell behaviour, which enables the fabrication of artificial skin, cartilage, blood vessels, and other engineered tissues and organs.101,102
Structural scaffolds are 3D frameworks composed of biomaterials that provide physical support for the regeneration of tissues and organs. Scaffolds are typically seeded with cells and act as templates that guide the formation of new tissues. They can be used to build tissues outside of the body and then implanted back in the body or they can be placed directly inside the body (e.g., through injection) where they facilitate tissue growth and regeneration in the body.103,104
The biomaterials used to build scaffolds are specifically designed to interact with biological systems to treat, restore, or replace tissues, organs, or functions in the body. The 4 major biomaterials that are commonly used in the fabrication of scaffolds are:
polymers (either natural or synthetic)
bioceramics (e.g., hydroxyapatite)
metals (e.g., stainless steel, aluminum, titanium alloys)
carbon-based nanomaterials (e.g., graphene oxide).103
Scaffolds and biomaterials support a range of tissue engineering applications, including the development of bioengineered skin and other complex tissues.105
Injectable hydrogels have been designed with mechanical properties that make them compatible with highly dynamic tissues such as the heart or vocal cords.106
Tissue engineering scaffolds and injectable hydrogels for bone regeneration have been developed by researchers at the Biological and Bioinspired Materials Laboratory at the University of Toronto’s Faculty of Dentistry.107
Engineered cartilage grafts developed by culturing cartilage-forming cells within a collagen-based scaffold are being investigated as a treatment for knee osteoarthritis (NCT06576583).108
Mattisse is a biodegradable scaffold used in tissue engineering for patients undergoing breast reconstruction after mastectomy for cancer (NCT05460780).109
Scaffold technologies will enable precise control over tissue architecture, mechanical properties, and function as tissue engineering advances from relatively simple, nonvascularized tissue (e.g., cartilage) to more complex structures and whole organs.110
Hybrid scaffolds made from both natural and synthetic biomaterials may improve the biocompatibility and biomechanical properties of tissue-engineered products and could support the development of advanced therapeutics, such as stem cell–loaded transplantable scaffolds for spinal cord injury.110,111
Injectable scaffolds provide a minimally invasive approach for supporting natural tissue regeneration. This could improve recovery times for a range of injuries, including cartilage defects, bone fractures, and soft tissue damage.112,113
Workshop participants discussed several areas where scaffolds and biomaterials may have broader use in clinical care.
Corneal scaffolds that imitate the natural structure of the cornea and support attachment, growth, and differentiation of stem cells show strong potential for corneal regeneration and are being investigated in many clinical trials.114 These scaffold-based technologies could help to address the global shortage of donor corneas.115
Similarly, bioprosthetic heart valves constructed using natural scaffolds (e.g., collagen or decellularized scaffolds) or synthetic scaffolds (e.g., polymer-derived materials) are demonstrating promise in preclinical research and clinical studies.116
Participants noted that although full bioartificial organ transplants enabled by scaffold technologies remain a longer-term goal, these applications show the potential for scaffold-based technologies to have real clinical impact in the coming years.
Regenerative medicine comes with unique patient safety considerations for regulatory and clinical decision-making because many therapies carry the potential for serious or irreversible harm. Unlike conventional drug therapies, regenerative approaches are often irreversible. Once they are administered, they cannot be withdrawn if a patient develops adverse effects or toxicity.117 For example:
Cell and gene therapies may behave unpredictably, with risks including tumour formation resulting from off-target gene editing, unintended transformation of stem cells into neoplastic (tumour) cells, or unexpected changes in genes or gene regulation.118-121
Implanted artificial organs or engineered tissues may dislodge or migrate, potentially causing permanent injury.122,123
Maintaining optimal conditions throughout the supply chain, including during storage and transport, is another significant safety challenge because products containing living materials require precise temperature and environmental controls. Even minor lapses in handling or transportation could compromise product viability, safety, or effectiveness.124
Safety concerns also arise from the source of biological materials. Using xenogeneic (i.e., nonhuman) cells or tissues may increase the risk of zoonotic diseases, which are infections that can spread from animals to humans.125 Combining human and nonhuman materials at the cellular or genetic level may introduce unexpected risks.123,126 These concerns extend beyond individual patients because regenerative therapies derived from animal cells or tissues could contribute to the emergence or spread of infectious diseases with broader public health implications.127,128
Workshop participants emphasized that patient safety must remain the top priority in regenerative medicine, as with all health care. They noted that Canada’s existing regulatory, legal, and ethical frameworks already provide important protections for patients, but that some regenerative medicine therapies carry greater uncertainty in their safety profiles compared to small molecule drugs because of their biological complexity and potential to trigger an immune response.
Participants also discussed that decisions about using these therapies are becoming increasingly individualized and values-based: Individuals with life-threatening conditions may be more willing to accept higher levels of uncertainty or potential harm, while those with non–life-threatening conditions with a goal of therapy to improve quality of life may be less willing to take such risks.
Potential solutions could include:
Conducting rigorous preclinical testing to evaluate the safety, stability, and unique risks associated with new regenerative medicine products.
Collecting long-term follow-up data in clinical trials to identify delayed or unforeseen risks and to build more robust safety data.121
Strengthening stringent quality control measures across production, storage, and transport, while ensuring full compliance with good manufacturing practices to ensure product consistency, purity, and safety.129
Developing a transparent and consistent decision-making approach for regulatory decisions about advancing regenerative medicine therapies from preclinical studies to first-in-human trials, which could help balance the need for new treatments for serious or life-threatening conditions with the uncertainty about their benefits and risks. Although the specific criteria may not be uniform across all therapies, a clear and consistent process for these early development decisions could promote fairness, clarify evidence expectations for researchers, and support clinicians and patients in making informed decisions about participation in early trials (refer to Issue 5: Alternative Models for Research, Product Development, and Regulation for additional information).130,131
Equity is the principle of considering people’s unique experiences, differing situations, and diverse needs to ensure they have access to the resources and opportunities for them to attain just outcomes. Health equity is achieved when everyone has the opportunity to attain their full potential for health and well-being, regardless of the conditions in which people are born, grow, live, work, play, and age.132
As emerging regenerative medicine technologies become available, their implementation raises important considerations related to health equity.133
Many therapies require specialized infrastructure (e.g., advanced laboratories), resources, and trained personnel. These are often concentrated in certain regions, creating geographic and resource-based barriers for patients. Systemic barriers, including those related to location, resources, or socioeconomic status, disproportionately affect some groups, and access to regenerative therapeutics may vary based on characteristics such as race, ethnicity, age, place of residence, and sex or gender.134 For example, a systematic review135 found significant disparities in access to hematopoietic stem cell transplantation for the treatment of bone marrow diseases, with race or ethnicity influencing both access and outcomes, including overall survival, progression-free survival, treatment-related mortality, and relapse. Another study,136 which was conducted in Canada, showed that province of residence, age, and gender affected the likelihood of receiving a hematopoietic stem cell transplant for acute myeloid leukemia.
Addressing these types of disparities through thoughtful planning and collaboration across health systems may help ensure that the benefits of regenerative medicine are more equitably realized.
Health equity is further challenged in areas where regenerative medicine relies on scarce biological materials, such as donor cells, tissues, or organs. Fair and transparent allocation processes are essential in these contexts for supporting equitable access.137 A clear example of these challenges emerged during a capacity crisis in Ontario in 2015, when resource constraints led to extended waitlists for allogeneic stem cell transplants across the province.138 In response, Princess Margaret Cancer Centre in Toronto, the hospital with the largest and most comprehensive malignant hematology program in Canada, developed a framework to guide ethical and transparent decision-making for stem cell transplantation during periods of scarcity.138
Although this represents a specific scenario, it underscores a broader principle relevant across regenerative medicine: When resources are limited, the criteria for allocating care should be developed transparently and with meaningful involvement from the affected patient groups and communities. It also raises important questions about where such decisions should be made: at the hospital level, the provincial or territorial level, or through coordinated national approaches. It also raises questions about how equitable access can be provided to patients living in jurisdictions or regions that may not offer the therapy because of resource constraints or limited manufacturing capacity, including through travel to and from central specialized facilities.
During the workshop, participants discussed several challenges and considerations related to equitable access and implementation. They emphasized that health equity is a significant concern in regenerative medicine because many emerging technologies can only be delivered through specialized centres equipped with advanced laboratory infrastructure and highly trained personnel.139 This concentration of resources and expertise raises the risk of geographic disparities in access, in which regenerative therapies may be accessible primarily to those patients living near major urban centres or academic institutions.
Participants noted that when patients and their families must travel far from their homes, workplaces, and communities to receive treatment, additional supports may be needed to prevent widening health care inequities, such as financial assistance and reliable follow-up services.
Potential solutions could include:
Workshop participants noted that many regenerative technologies are complex to manufacture and challenging to scale.140 Improving scalability, such as by expanding manufacturing capacity through decentralized production across multiple geographic locations, could help reduce manufacturing bottlenecks and allow patients to access these therapies closer to where they live (refer to Issue 3: Scalability for additional details).141,142
Improving affordability through innovative and coordinated funding approaches and strategic partnerships could reduce production costs and financial barriers for both health systems and patients.143 Participants agreed that addressing these interconnected challenges is an important step in improving equitable access to emerging technologies.
Scalability refers to the ability of a health intervention to be expanded or produced effectively under real-world conditions and in sufficient quantities to reach a larger proportion of potential patients.144
Many regenerative medicines are difficult to manufacture at scale (in large quantities while maintaining quality) and face implementation challenges in moving from experimental and early clinical settings to widespread clinical use. Producing cell-based products, biomaterials, or other complex biological products on a large scale requires highly precise, standardized, and reproducible manufacturing processes. However, this level of control is difficult to achieve given current limitations in bioreactor technologies, which are not often optimized for maintaining cell viability and consistency at high volumes.145
Logistical challenges related to the distribution and storage of specialized materials and living products further complicate large-scale production.146 For products for which decentralized manufacturing is possible, coordinating quality control across multiple sites adds further complexity because it becomes more difficult to keep processes consistent, such as standardized cell culture conditions.147-149
A separate scalability challenge arises when therapies are derived from a patient’s own cells or are tailored to their unique biological characteristics, which prevents any possibility of mass production.150 For example, CAR T-cell therapies rely on collecting and modifying each patient’s own T cells, making the process inherently complex and time-consuming.151 Many patients undergo intensive treatments, such as chemotherapy or radiation, before becoming eligible for CAR T-cell therapy. These treatments can severely deplete their T cells and, in some cases, make it impossible to generate a viable CAR T-cell therapy. For those who can proceed, the treatment involves several sequential steps:
harvest T cells from the patient
carefully transport them to specialized laboratories with limited manufacturing capacity
genetically engineer and expand (i.e., multiply) them under controlled conditions to enhance their cancer-fighting ability
ship the cells back
reinfuse the cells into the patient.152
This multistage process can take several weeks, during which time the patient’s condition may deteriorate.153,154 Because each cell product must be produced individually and laboratory capacity is limited, it is difficult to produce these therapies quickly at large scale. This example with CAR T-cell therapies represents a specific scenario, but it illustrates the scalability challenges encountered across many regenerative medicine therapies that are personalized to individual patients.
Workshop participants expressed that scalability is a key concern in the regenerative medicine field. They noted that it is a complex issue involving many moving parts between the development of therapies and the patients who would benefit from them.
Participants expressed that regenerative medicine technologies are difficult to scale, with limited manufacturing capacity in Canada. The COVID-19 pandemic highlighted broader gaps in Canada’s biomanufacturing infrastructure. Canada’s limited ability to produce vaccines domestically showed how system-level capacity constraints can impede access to critical health technologies.155 Participants viewed this as reinforcing the need to expand domestic manufacturing capacity. Canada could leverage its scientific expertise and expand its own manufacturing capacity. This could reduce reliance on international suppliers, support access to these innovations in Canada, and help maintain the country’s position as a global leader in regenerative medicine research and treatment.156
Scalability was also described as a particularly difficult challenge resulting from the gap between research and application. Although many new regenerative medicine technologies receive early research funding, the workshop participants noted that few of these progress beyond the laboratory because of the rigorous work required to demonstrate safety and to show that the therapy can be manufactured consistently and in sufficient quantities for clinical use.
Workshop participants also discussed that scalability could contribute to disparities in access, alongside other important considerations. Improving scalability may allow regenerative medicine technologies to become more broadly available and help reduce disparities in access (refer to Issue 2: Disparities in Access to and Implementation of Emerging Technologies for additional details).
Potential solutions could include:
Researchers in Canada and at BioCanRx are advancing a decentralized point-of-care manufacturing model in which the patient-specific cell product is produced at treatment centres across the country. By bringing manufacturing closer to where treatment is delivered, this approach could reduce shipping times, logistical costs, and avoid the need to transport complex products across provincial, territorial, or national borders.148 This “made-in-Canada” model aims to expand domestic manufacturing capacity for advanced therapies and shorten the time patients have to wait to receive treatment.41
Using automated technologies to precisely print biomaterials may support more scalable and cost-effective manufacturing. These technologies can reduce waste of expensive bioactive components and ensure consistency in each batch. Synthetic materials that are cheaper and easier to produce than natural biomaterials may also improve scalability.157
Strengthening collaboration between researchers, manufacturing companies, and regulators could also improve scalability. Coordinated efforts could help establish standardized production methods, develop material libraries, and streamline regulatory processes, which could help to lower the cost of bringing new treatments to patients.158
The implementation of regenerative medicine technologies presents opportunities and challenges for health systems. Scalability focuses on how easily therapies can be manufactured in large quantities; health system capacity, workforce readiness, and affordability relate to whether health systems are prepared to integrate, deliver, and sustainably manage the financial impact of these therapies as part of routine care.
Many of these therapies will require specialized facilities, equipment, and advanced infrastructure.146 This creates a growing need for a skilled workforce, including clinicians, technicians, and support staff trained in the safe handling and administration of biological products. In Canada, there is strong scientific expertise and growing training opportunities in regenerative medicine,14 yet our health care systems are also experiencing significant strain due to staffing shortages, clinician burnout, long wait times, and limited resources.159,160 These pressures raise concerns about the system’s capacity to support the introduction of new regenerative medicine therapies.
Preparing health systems with the facilities, infrastructure, and workforce needed to successfully deliver these technologies will require substantial planning and investment. Regenerative medicine therapies may offer long-term benefits by improving patient outcomes, reducing ongoing treatment needs, and providing broader societal benefits (e.g., increased productivity when patients and caregivers are able to return to work); however, initial investments in their development and implementation often involve high costs.161-163
Regenerative medicine therapies also challenge existing funding and budgeting structures. Unlike many conventional treatments for chronic diseases, which spread out costs over months or years, many cell and gene therapies involve high short-term costs and are intended to be delivered as one-time, potentially curative treatments.164 These challenges are compounded by the personalized nature of many regenerative medicine therapies, which are inherently difficult to scale (refer to Issue 3: Scalability for additional information).
Workshop participants discussed several health system challenges that could affect the adoption of regenerative medicine therapies. They noted that the health care workforce is already navigating challenges in ensuring timely access to the therapies that are already available, and that the introduction of more complex regenerative therapies could add to this strain, especially because many regenerative medicine therapies require extensive follow-up care.
Participants highlighted that this issue is closely tied to affordability because health systems may not have the resources needed to support these advanced treatments. Examples of necessary resourcing may include staff with the skills and training (e.g., cell culture specialists, biomedical engineers), distribution chains that support the transport of live cells and engineered tissues and organs, and biomanufacturing facilities.165-167 This resourcing challenge is particularly significant in smaller provinces or territories, where individualized therapies place additional demands on already limited capacity.
In addition to workforce concerns, participants discussed the substantial costs associated with developing and delivering regenerative medicine. Specialized manufacturing facilities and complex clinical trials contribute to high development costs. In many areas, small patient populations and uncertain market size mean there is limited financial incentive for biotech companies to invest in developing new therapies. Participants noted that improving affordability and access will require new models for market entry that can better support innovation.
Canada has an opportunity to lead in redefining development and assessment paradigms for regenerative medicine by exploring innovative approaches that balance patient access and health system sustainability.
Potential solutions could include:
Greater international collaboration among regulators, developers, and payers, as well as alternative models of intellectual property management (e.g., open licensing or time-limited exclusivity) could help accelerate innovation in product design and development while supporting long-term sustainability for both payers and manufacturers.168
Innovative manufacturing approaches could help reduce costs and improve efficiency. Examples include decentralized or point-of-care manufacturing models or exploring the use of automation and artificial intelligence to better characterize cells.41,169,170
One example of an innovative approach is the Platform Vector Gene Therapy pilot project by the National Institutes of Health.171,172 This project involves the collaboration of researchers and experts from multiple institutions to create a shared platform to test the same gene therapy delivery system and manufacturing process for 4 rare genetic illnesses. By standardizing these elements, the project aims to streamline clinical trials and make them more efficient and replicable across similar therapies. The initiative is committed to publicly sharing its experience with the scientific and regulatory processes involved, including sharing information on regulatory applications, biodistribution and toxicology results, and communications with regulators. This open-source model promotes transparency and allows other research teams to build on these insights, helping them streamline and strengthen their own drug development processes.170
Exploring opportunities for developers and payers to share financial risk when introducing high-cost, potentially curative therapies, which could establish structured pathways for coverage and adoption while protecting health system sustainability.168,173-175
Investments in specialized training programs (e.g., through centres of excellence) could help ensure treatments are delivered safely and effectively, while also creating high-skill jobs and reinforcing Canada’s position as a global leader in this emerging field.123 For example, the Canadian Partnership for Research in Immunotherapy Manufacturing Excellence, a partnership between The Ottawa Hospital, Algonquin College, the University of Ottawa, and Mitacs, provides students with hands-on training at The Ottawa Hospital’s Biotherapeutics Manufacturing Centre, which produces biotherapeutics such as stem cells and CAR T-cell therapies for clinical trials.176 Similarly, the Canadian Advanced Therapies Training Institute, in partnership with Centre for Commercialization of Regenerative Medicine and the University of Guelph, offers biomanufacturing training for recent graduates and industry professionals.177,178 This program helps build the skilled workforce in this field in Canada.
The current research, product development, and regulatory ecosystems in Canada do not align optimally with the unique characteristics of some emerging regenerative medicine therapies, which may be highly individualized, complex to manufacture, and combine living and nonliving materials into a single product (e.g., bioartificial organs).118,179,180
Regenerative medicine products that show promising potential in preclinical research encounter significant hurdles as they advance to early clinical trials. Regulatory pathways for regenerative medicine products are still evolving and differ internationally, creating uncertainty about what evidence is required to demonstrate the safety and effectiveness of a product, and how trials should be designed to meet regulatory requirements.181-184 For example, jurisdictions may differ in how long early clinical trials must run for a product to progress to the next phase of development (e.g., from phase I to phase II), as well as in the long-term follow-up data they expect to be generated.185-188 This uncertainty contributes to high costs for product sponsors, who must invest in activities such as research, clinical trials, and regulatory documentation to meet evolving and often nonharmonized requirements across international jurisdictions.179,189
As products move into large-scale clinical studies, investigators often face challenges related to study design, patient recruitment, and product standardization. Many regenerative therapies target rare or diverse conditions, making it difficult to recruit sufficient numbers of patients for adequately powered clinical trials, especially when there may be barriers to interjurisdictional data sharing.190,191 In addition, these therapies are often highly personalized, meaning each patient may receive a unique treatment tailored specifically to their biology. This individualization makes it difficult to systematically evaluate the benefits and harms because outcomes may vary between individuals.
Workshop participants highlighted that Canada faces significant challenges related to the development and regulation of regenerative medicine therapies. They noted that it is increasingly difficult to generate strong evidence that a product has high therapeutic potential, and decisions on which therapies or technologies should continue to be developed are being made based on smaller clinical trials.
Participants also suggested there is an opportunity to adapt the regulatory and development process, noting that standard regulatory rules cannot be easily applied across different disciplines (e.g., tissue engineering, gene therapies, and cell-based products). Participants described current procedures as time-consuming and complex compared to the adaptive regulatory approaches used during the COVID-19 response. Although they perceived it was helpful for accelerating innovation, they did not specify which mechanisms contributed to this agility.
Participants discussed that current policies and system structures offer limited pathways to support innovation, research, or experimentation, either within the system or through external collaboration. These challenges are further complicated by limited opportunities to fund pilot projects or test new approaches through milestone-based initiatives (i.e., funding mechanisms that tie payments to specific, predefined goals or achievements), which could help identify and address system inefficiencies. Collectively, these factors may slow innovation in the regenerative medicine field.
These discussion points align with broader calls to improve approaches used in Canada to support the development and commercialization of emerging science, which could strengthen national competitiveness and provide important economic and societal benefits.15 To address these challenges and support innovation, a shift toward more iterative and adaptive models of research and development may be considered that promote early and ongoing collaboration and alignment between patients, clinicians, scientists, industry, regulators, and payers.189
Potential solutions could include:
New models for research funding, intellectual property management, and localized manufacturing capacity at or close to the point-of-care could improve the efficiency of the product development process while prioritizing public interest goals beyond commercialization, such as accessibility, transparency, and sustainability.192 Some therapeutic approaches developed outside traditional commercial pathways have already demonstrated how alternative models can achieve broad adoption and success within health care systems in Canada, such as with whole organ and bone marrow transplants.193,194
Tailoring, innovating, or evolving regulatory pathways for complex products could improve the quality of submissions to regulators, create efficiencies in the technology development process, and potentially make therapies available to patients sooner.
Some regulators, including Health Canada, have explored accelerated or conditional approval pathways. These allow time-limited market authorization for innovative technologies while requiring further evidence generation in real-world settings.195
Health Canada is developing a related framework for regulating and authorizing advanced therapeutic products, which are therapies so unique, complex, and distinct that they challenge traditional regulatory models.196 This framework can be tailored to a particular type of product and is intended to provide a stable and robust pathway to market authorization for products with an insurmountable regulatory barrier.197 Greater clarity on the types of therapies that could be evaluated as an advanced therapeutic product could help support industry planning.142,198,199
Health Canada has also proposed a new, stand-alone framework that would regulate the conduct of clinical trials involving drugs for human use. It is intended to better support innovative trials, facilitate decentralized trials, and reduce the burden on industry by tailoring certain requirements in accordance with the risk level of drugs used in a clinical trial.200
The European Medicines Agency has introduced a range of incentives for therapies that receive orphan drug designation, a regulatory status assigned to drugs intended to treat rare diseases. These include financial and regulatory supports, such as scientific advice and protocol assistance to sponsors, extended market exclusivity, and regulatory fee reductions, encouraging market entry for novel treatments.142
Increasing international harmonization of regulatory requirements and clinical trials guidance could promote global collaboration and facilitate multinational clinical trials.201 Agencies such as the European Medicines Agency, the US FDA, and Ministry of Food and Drug Safety in South Korea have issued guidance on the design of clinical trials for cellular and gene therapies, including innovative and efficient trial designs. These agencies recognize that these products present distinct methodological challenges that may limit the feasibility of traditional trial approaches.202,203 In such cases, robust postmarket surveillance of regenerative medicine therapies through patient registries and other data sources becomes essential to better understand long-term outcomes, including biomaterial degradation and potential carcinogenic risks.204
Intellectual property modalities that incorporate open-access principles and use alternative licensing models could lead to increased access to new therapies for patients.
The items on the 2026 Watch List were selected by people with diverse expertise in the applications of regenerative medicine, including a caregiver with lived experience, clinicians, researchers, members of industry, innovators, ethicists, policy experts, and health care decision-makers. A key strength of this work lies in bringing together these multiple perspectives to discuss the potential of regenerative medicine to create significant and meaningful impacts on health care systems in Canada over the next 5 years.
Throughout these discussions, a consistent theme emerged: Meaningful engagement among regulators, innovators, industry, clinicians, and patients is essential to maximize the potential of regenerative medicine and to support the safe, effective, and accessible implementation of new technologies.
Its strong academic foundation, collaborative research networks, and growing commercialization ecosystem position Canada well to continue contributing to global leadership in regenerative medicine. The insights captured through this Watch List can inform policy development and health system planning to support the continued advancement of regenerative medicine technologies, help keep Canadian innovations in Canada, and ensure that people living in Canada can access and benefit from these advances through equitable, high-quality care in the years ahead.
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CDA-AMC is grateful to the Advisory Group for the 2026 Watch List. They provided project oversight and considerations about items to include, helped refine the initial 25-item list, and reviewed the draft version of this report.
Doris Grant Managing Director, Nova Scotia Health Innovation Hub; Chief Executive Officer, Life Sciences Nova Scotia
Sandra Holdsworth Patient partner
Ubaka Ogbogu Professor, University of Alberta
Michael Rudnicki Senior Scientist, Ottawa Hospital Research Institute; Director, Sprott Centre for Stem Cell Research; Scientific Director, Stem Cell Network
David Thompson Clinical Assistant Professor, University of British Columbia
CDA-AMC is grateful to the workshop participants for their time, sharing of their expertise and experiences, and for selecting the final items included in the 2026 Watch List. Their participation, insights, and willingness to collaborate were integral to developing the list. Participants were generous with their ideas and their time — we thank you for your collaboration and expertise.
Amanda Allard Associate Director, Vertex Pharmaceuticals
Keith Brunt Associate Professor, Dalhousie University; Adjunct Professor, University of New Brunswick; Translational Scientist, New Brunswick Heart Centre; Chief Scientific Officer, Nota Bene Bio Matrix (NBBM) Inc.
Jean-Sébastien Delisle Professor, University of Montreal; Clinician-Scientist, Maisonneuve-Rosemont Hospital; Director, ThéCell
Colin Hoeft Innovation Specialist, Saskatchewan Health Authority
Adam Johnston Associate Professor, Dalhousie University
Michael Laflamme Robert McEwen Chair in Cardiac Regenerative Medicine; Canada Research Chair in Cardiovascular Regenerative Medicine; Senior Scientist, University Health Network; Professor, University of Toronto; Founding Investigator, BlueRock Therapeutics
Sarah Linklater Chief Scientific Officer, Breakthrough T1D Canada
Jennifer MacWhirter-DiRaimo Patient caregiver; Genetic Counsellor, GenomiCare Genetic Counselling; Board Director, Canadian Hemophilia Society
Stéphanie Michaud President and Chief Executive Officer, BioCanRx
Marcelo Muñoz Associate Scientist, University of Ottawa Heart Institute
Cate Murray President and Chief Executive Officer, Stem Cell Network
Denis Claude Roy Professor, University of Montreal; Chief Executive Officer, CellCAN; Chief Scientific Officer, Centre for the Commercialization of Cancer Immunotherapy and Regenerative Medicine; Director, University Institute of Hemato-Oncology and Cellular Therapy, Maisonneuve-Rosemont Hospital
Dean Ruether Medical Director for Community Oncology, Alberta Health Services
Lisa Schwartz Arnold L. Johnson Chair in Health Care Ethics; Professor, McMaster University
David Szwajcer Program Director, Manitoba Blood and Marrow Transplant; Medical Director, Cell Therapy Laboratory at CancerCare Manitoba; Medical Director, Manitoba Advanced Cell and Tissue Therapy Laboratory
Sowmya Viswanathan Scientist, University Health Network; Assistant Professor, University of Toronto
Marika Warren Health Care Ethicist, Nova Scotia Health Ethics Network; Assistant Professor, Dalhousie University
Stephanie Willerth Chief Executive Officer, Axolotl Biosciences; Professor, University of Victoria
Amy Zarzeczny Professor, University of Regina; External Research Fellow, University of Alberta
Advisory group members declared the following conflicts:
Doris Grant declared nonfinancial interests related to their roles as CEO of Life Sciences Nova Scotia and Managing Director of Nova Scotia Health Innovation Hub.
Sandra Holdsworth indicated they have received payments for advisory or consultancy work, speaking engagements, or travel or other expenses from the Transplant AI Initiative and the University Health Network (Bhat Labs), as well as honorariums from the Centre of Digital Health Evaluations, the Minister’s Patient and Family Advisory Council, and from researchers at various hospitals. They also disclosed involvement in the 2025 Watch List as an Advisory Group member.
Michael Rudnicki declared the following financial interests: employment with the Stem Cell Network and Satellos, receipt of honorariums from Regeneron for presenting a seminar, and research funding from the Stem Cell Network. They also declared nonfinancial interests relating to their roles as Scientific Founder and Chief Discovery Officer with Satellos.
Workshop participants declared the following conflicts:
Amanda Allard declared financial interests from Vertex Pharmaceuticals (Canada) Inc. and nonfinancial interests relating to their participation in a workshop organized by the Stem Cell Network and Breakthrough T1D, as well as recent involvement in activities related to the Scientific Advice Program of CDA-AMC.
Keith Brunt reported financial interests related to Nota Bene Bio Matrix (NBBM) Inc., ProtoKinetix Inc., Routinify Inc., FibroGen Inc., Zymeworks Inc., Liminal Sciences Inc., Pivotal Health Sciences Inc. (Pividl Bioscience Inc.), Cloud – Diagnostics Inc., Medtronic Inc., AusculSciences Inc., Pfizer Inc., Kraken Sense Inc., Ecoli Sense Ltd., DCS Controls Ltd., DCS-Nano Filtration Enterprises Inc., Nano Technologies Inc., Eli Lilly, Bristol Myers Squibb, Johnson & Johnson Innovative Medicine, Elanco, CVS Health, BioNTech, Viemed Healthcare, Regeneron Pharmaceuticals, Moderna, Resverlogix, Alnylam Pharmaceutical Inc., AngioDynamics, AtriCure Inc., Aycoutey Inc., and SeafarerAI Inc. Keith Brunt also reported receiving direct or indirect funding, in-kind contributions, or cost recovery through billing or consulting fees from the National Research Council Canada, the Nanomedicine Innovation Network, the Public Health Agency of Canada, and the Government of New Brunswick.
Jean-Sébastien Delisle declared the following financial interests: receipt of intellectual property rights from the University of Montreal and CIUSSS-EMTL, research funding or grants from Epitopea, and funding or honorariums from the University of Montreal and the Maisonneuve-Rosemont Hospital Research Centre. They declared nonfinancial interests relating to their roles as Director of the Québec Cell, Tissue and Gene Therapy Network and as Principal Investigator for the EBV-TCL-01 clinical trial.
Colin Hoeft declared financial interests through employment with Saskatchewan Health Authority and CAN Health Network, and for receiving funding or honorariums for speaking engagements with the Saskatchewan Association of Medical Imaging Managers and xCamp by zu. They declared nonfinancial interests related to anticipated participation in a voluntary committee with HealthPRO Canada.
Michael Laflamme disclosed financial interests from BlueRock Therapeutics related to roles as scientific founder and consultant.
Sarah Linklater declared that Vertex Pharmaceuticals has provided sponsorship funding to Breakthrough T1D, where they are employed as Chief Scientific Officer.
Jennifer MacWhirter-DiRaimo disclosed financial interests through employment with GenomiCare Consulting Ltd. and the Platelet Disorder Support Association, as well as educational funding from RareKids-CAN. They declared nonfinancial interests related to their roles as a member of the board of directors of the Network of Rare Blood Disorder Organizations, a member of the board of directors of the Canadian Hemophilia Society, as chair of the research grant subcommittee at the Canadian Association of Genetic Counsellors, and as a patient member of the Patient Advisors Network. They also disclosed participating in Immune Thrombocytopenia Awareness Day activities at Queen’s Park to advocate for access to second-line therapies.
Stéphanie Michaud declared financial and nonfinancial interests related to their roles as President and CEO of BioCanRx, a not-for-profit organization that funds preclinical to clinical development of various immunotherapies and engages with federal and provincial governments on the performance of the health research ecosystem.
Marcelo Muñoz declared financial interests related to their employment at the University of Ottawa Heart Institute, including the receipt of intellectual property rights and research funding or grants. They also disclosed involvement in recent CDA-AMC projects related to tissue-engineered vascular grafts and regenerative materials for corneal repair.
Denis Claude Roy declared the following financial interests: employment at the University of Montreal, the Centre for the Commercialization of Cancer Immunotherapy and Regenerative Medicine, and the University Institute of Hemato-Oncology and Cellular Therapy at Maisonneuve-Rosemont Hospital; receipt of shares, stocks, or stock options from Boston Scientific; research funding or grants from CIHR, Cancer Research Society, BioCanRx, Medicament Québec, the Quebec Government, and the Canadian Foundation for Innovation; and funding or honorariums for speaking engagements with CEL for Healthcare. They declared nonfinancial interests relating to their role with the Cell Therapy and Regenerative Medicine Network (CellCAN).
Lisa Schwartz declared nonfinancial interests related to a role as a member of the Data Safety Monitoring Committee for the Canadian Cancer Trials Group, which reviews clinical trials that may involve regenerative therapies.
David Szwajcer indicated financial interests in the form of research funding or grants from BioCanRx and from payment for advisory or consultancy roles with CDA-AMC.
Sowmya Viswanathan declared financial interests related to their role as a Scientific Advisor to eQcell Inc.
Marika Warren declared nonfinancial interests related to their roles as President-elect of the Canadian Bioethics Society, a member of the ethics committee at Atlantic Fertility, and a member of the board of directors of the Canadian Association of Practising Healthcare Ethicists.
Stephanie Willerth declared the following financial interests: employment at the University of Victoria; receipt of shares, stocks, or stock options from Axolotl Biosciences; research funding or grants from NSERC and Forest Ministry; and financial payment from Horizon 2020 for reviewing grants. They declared nonfinancial interests relating to their roles with Engineers and Geoscientists of British Columbia and the Massachusetts Institute of Technology.
Amy Zarzeczny declared financial interests related to research grants from the Stem Cell Network, the Canadian Institutes of Health Research, and the Saskatchewan Health Research Foundation. They also declared nonfinancial interests related to their roles as a member of the Editorial Board for the Health Reform Observer and a member of the board of directors of the Justice Emmett Hall Memorial Foundation.
Please note that this appendix has not been copy-edited.
In July 2025, we invited 5 experts (external to CDA-AMC) to participate as members of the Advisory Group to guide the project. The Advisory Group brought diverse perspectives on the applications of regenerative medicine as patients, clinicians, researchers, innovators, policy experts, and health care decision-makers with expertise in the development and application of clinical regenerative tools, health system transformation, policy and ethics, and patient and/or caregiver perspectives. Roles of this group included:
providing guidance and input on the project scope, including validating the definitions and prioritization criteria
helping to identify and refine items for the initial list
suggesting potential workshop participants
reviewing the content of the draft report.
To guide the selection of items for the Watch List, we developed prioritization criteria from multiple sources, including the CDA-AMC Strategic Plan,205 the International Network of Agencies for Health Technology Assessment (INAHTA) position statement on disruptive technologies,206 health system priorities as determined by CDA-AMC intelligence gathering, and previous Watch Lists. Common elements across these sources were organized into 4 domains of impact:
Patients’ and caregivers’ experiences and outcomes
Health care delivery and organization
Resource utilization (technical, environmental, and health human resources)
Health equity and access
Each domain included prompts and key considerations to guide the assessment of potential impacts across health system, health care facility, and patient and caregiver levels. The draft criteria were circulated to the Advisory Group for review to ensure accuracy and relevance, and the final criteria are presented in Table 1.
Table 1: Prioritization Criteria for Selecting Items for the Initial List
Domains | Area of significant and meaningful change |
|---|---|
Patients’ and caregivers’ experiences and outcomes |
|
Health care delivery and organization |
|
Resource utilization (technical, environmental, and health human resources) |
|
Health equity and access |
|
Following the prioritization criteria, the goal of this step was to identify and describe 20 to 30 new and emerging regenerative medicine platforms (i.e., therapeutic modalities) and related issues with the potential to substantially impact health care delivery and planning in Canada over the next 5 years. The project team considered impact to be significant and meaningful changes in patients’ and caregivers’ experiences and outcomes, health care delivery and organization, resource utilization, and health equity and access. For clarity, significant and meaningful change was defined as changes that would require the addition of new, or modification of existing, resources, policies, or procedures to successfully adopt and implement technologies. These areas of change were selected because they are relevant to health care policy and planning and support system readiness for integrating new technologies.
A 5-year time frame was used to guide the item identification process, reflecting the rapid pace of innovation in regenerative medicine and focusing attention on technologies that are further along in development or show strong potential for near-term adoption in Canada or comparable health care contexts.
Literature Search Methods
An information specialist conducted 2 exploratory literature searches, balancing comprehensiveness with relevance, of multiple sources on July 29, 2025. An additional search was conducted on August 19, 2025. Refer to Appendix 3 for the detailed search strategies.
Literature Screening and Item Selection
Three researchers independently screened the retrieved records to identify new and emerging regenerative medicine platforms and related issues for further discussion. In the first level of screening, the reviewers independently evaluated the titles and abstracts of all retrieved records (i.e., articles from electronic databases and other sources) for relevance in duplicate. Full texts were retrieved to further evaluate potentially relevant items, as needed. The electronic searches were supplemented by informal web searching for additional information sources, including news articles, industry reports, blogs, and websites.
We used the criteria in Table 1 to identify items (i.e., both technologies and issues) by asking:
Does the technology (either as a discrete technology or as a group of technologies) have a clear value proposition (i.e., what it is intended to do, who it benefits, and how) that is anticipated or positioned to make a significant or meaningful change in 1 or more of the domains outlined in Table 1.
Is the issue anticipated or positioned to contribute to a significant or meaningful change in 1 or more of the domains in Table 1 and/or does it affect the ability for the value proposition of regenerative medicine technologies to be realized by patients, caregivers, clinicians, or health systems?
As items emerged from these information sources, they were added to a working list that included the name and a basic description of the technology or issue, relevant examples (prioritizing examples from within Canada when available), and anticipated benefits or consequences to patients and caregivers, clinicians, health systems, and payers. The 3 researchers met regularly to discuss findings, identify issues and trends in their observations, and note areas of consistency and discrepancies.
Following completion of the literature review, the project team reviewed the draft items and reflected on the project scope, definitions, and prioritization criteria. Through discussion, the items were refined, including collapsing, separating, and removing items when appropriate. The draft list was then shared with the Advisory Group for validation and to assess the credibility of items. Based on the Advisory Group’s written and oral feedback, further additions, removals, and revisions were made, resulting in a 25-item list used in step 3.
We adapted the transparent and inclusive priority-setting process of the JLA method16 to guide the online workshop and the selection of the top 10 items for the 2026 Watch List. The JLA principles align with CDA-AMC priorities of equal involvement and inclusivity (e.g., balanced representation from patients, health care providers, and other impacted parties), transparency (e.g., visible audit trail of submitted technologies and trends), and a commitment to using and contributing to the evidence base (e.g., using technologies and trends to inform future products produced by CDA-AMC.
Identifying and Recruiting Workshop Participants
We identified potential participants through project scoping, the literature review, CDA-AMC networks, and recommendations from the Advisory Group. In addition, an open call for participation was posted on the CDA-AMC website between July and October 2025. Interested individuals completed a web form describing their connection to regenerative medicine and how their experiences could contribute to the diversity of ideas being shared. Members of the project team invited individuals from a range of geographical settings (i.e., jurisdictions in Canada) and sought to include participants with diverse professional and personal backgrounds, including patient partners, caregivers, policy experts, researchers, industry representatives, and clinicians. CDA-AMC recognizes the importance of diversity, equity and inclusion, and the composition of the workshop participants took these considerations into account. A total of 65 individuals were contacted to determine their interest and availability. Of those, 18 individuals registered and 20 participated in the workshop. Two of the participants joined after a last-minute request but were unable to complete registration before attending. After the workshop, one of these participants completed the registration, while the other did not complete the required paperwork to be listed as a workshop contributor or submit a completed conflict of interest form.
Engagement With Indigenous Peoples and Organizations
CDA-AMC recognizes the sovereignty and jurisdiction of First Nations, Métis, and Inuit Peoples over community well-being. We understand that Indigenous Peoples’ experiences, values, needs, and priorities are important for understanding and improving the use of regenerative medicine in Canada. In conjunction with our Strategic Partner, Inclusion, Equity, Diversity, and Accessibility, CDA-AMC is currently fostering relationships with Indigenous Peoples and organizations. Without adequate time to develop respectful and meaningful relationships with Indigenous Peoples to inform this work, CDA-AMC is aware that any attempt to reflect Indigenous Knowledges and voices would not be culturally appropriate or safe and could further perpetuate harm. CDA-AMC acknowledges the lack of engagement and inclusion of Indigenous perspectives and voices as a major limitation and gap of this work.
The Half-Day Virtual Workshop to Select the Top 10 Technologies and Issues
Before the workshop, we provided participants with a hardcopy or electronic workshop guide, the 25-item list with summaries about each technology platform and issue, and a participant worksheet. Before attending the workshop, participants were asked to individually review and rank the technologies and issues in the initial list using the participant worksheet.
The half-day virtual workshop occurred on October 22, 2025. The workshop was led by a CDA-AMC staff member, who is a JLA Advisor, with 3 additional team members facilitating small group workshop sessions. The facilitators used a nominal group technique, which is a consensus-building method to support problem-solving and idea-generation or determining priorities among experts with different perspectives. A facilitation guide was followed to ensure that all participants had a consistent and inclusive experience in the discussion, so the JLA principles of equal involvement were upheld. Additional CDA-AMC team members participated as observers and provided technical and notetaking support.
The workshop had 2 parts. In the first part, participants were split into 4 small groups for an exercise in which each participant was asked to share their top-ranked and lowest-ranked items along with their rationale. Four facilitators (1 per group) recorded the responses. In the second part of the workshop, the facilitators met briefly to share the rankings from their groups and combined them into a preliminary draft list that reflected the collective ideas raised from all groups. This draft list then served as the starting point for a facilitated full-group discussion, during which participants further shared their perspectives on which items should be included. Through this consensus-building process, the group selected the top 5 technology platforms and top 5 issues that best represented the diverse views discussed.
We prepared a final report that described the top 10 technology platforms and issues and their impact on patients, caregivers, and health systems. Descriptions and examples were based on the published literature (identified during the list generation stage and/or by supplemental searching as needed), additional targeted internet searches, and discussions from the workshop.
Please note this appendix has not been copy-edited.
An information specialist conducted 2 exploratory searches on July 29, 2025, to generate an overview of current and emerging technologies in regenerative medicine. The search strategies reflected our working definition and included general terms for regenerative medicine, broad regenerative medicine approaches (e.g., stem cell therapies, cellular immunotherapies), specific technologies (e.g., bioprinting, biofabrication, tissue engineering), and intervention categories (e.g., wound dressings).
We identified:
regenerative medicine systematic reviews, health technology assessments, meta-analyses, and indirect treatment comparisons in Ovid MEDLINE and Ovid Embase
articles on trends and innovations in regenerative medicine in Ovid MEDLINE
conference reviews, conference abstracts, editorials, letters, and notes on trends and innovations in regenerative medicine in Ovid Embase.
We limited search results to English-language articles published since January 1, 2023, that excluded animal studies. Biweekly alerts updated the searches until December 1, 2025, when a draft version of the report was shared with the Advisory Group for feedback. An additional search was conducted in Ovid MEDLINE on August 19, 2025, for articles related to ethics and implementation in regenerative medicine. We limited search results to English-language review articles published since January 1, 2015, and excluded animal studies when possible. All search strategies are available upon request.
Please note that this appendix has not been copy-edited.
Table 2: List of Technologies Not Included in the Final Watch List
Technology | Description | Insights from the workshop |
|---|---|---|
3D bioprinting and bioinks | 3D bioprinting is a manufacturing technology used to create functional tissues and organs. It involves the layer-by-layer deposition of bioinks, which are mixtures of living cells (often sourced from the patient and expanded in culture) and supportive biomaterials (e.g., scaffolds on which cells can grow), in a precise, predetermined structural architecture designed to mimic the complex structure of human tissue. 3D bioprinting has the potential to produce patient-specific tissues and organs suitable for transplantation.207-209 | Participants noted that 3D bioprinting and bioinks still face major challenges before they can be clinically implemented. For example, they require large numbers of cells (much higher than other regenerative medicine approaches), and it remains difficult to achieve vascularization in 3D printed tissues and organs, which limits the size and complexity of tissues that can be implanted. Although the long-term potential is immense, participants did not expect broad clinical impact within the next 5 to 10 years, and that further progress in academic settings is needed. There is some international activity in wound repair (e.g., burns, diabetic ulcers),210 which could potentially be explored in Canada under special authorization pathways. Bioprinted tissues may have clinical uses in the near term for rare or orphan conditions in which life-threatening infections occur (e.g., epidermolysis bullosa) or there are no donor tissues are available (e.g., in urological disorders). Participants also mentioned that other specific products (e.g., bioprinted cartilage or heart valves) may emerge in the near term. |
Advanced bioactive nanomaterial-based technologies | Bioactive nanomaterials are structurally solid materials composed of nanoparticles with a size of 100 nm or less that can interact with living systems and induce biological responses. Many bioactive nanomaterials can be classified as inorganic nanomaterials (e.g., silver, gold, iron, silica, ceramic particles), polymeric nanomaterials, carbon-based nanomaterials (e.g., carbon nanotubes, graphene, and graphene oxide), or supramolecular nanomaterials (e.g., peptide-based).211 In regenerative medicine, these materials have potential applications in wound care, drug delivery (e.g., cell-instructive hydrogels), and tissue engineering.212-215 Due to their special physiochemical characteristics, they can imitate the extracellular matrix, modulate signalling pathways involved in tissue regeneration, and promote cell adhesion, proliferation, and migration.214 | Participants discussed that nanomaterial-based technologies have transformative potential for difficult to treat diseases (e.g., Alzheimer disease, inflammatory conditions) and can facilitate targeted drug delivery for other regenerative medicine therapies (e.g., antisense oligonucleotide therapies, gene therapies, mitochondrial transplantation). However, progress in Canada within the next 5 years is expected to be limited without systematic regulatory changes. In many jurisdictions, regulatory pathways require separate reviews for each component of a composite product, which creates significant barriers for nanomaterial-based technologies. Participants noted that there is a lot of regulatory uncertainty in Canada, and that the European Medicines Agency’s evolving approach may provide a more suitable model for regulating these products. There are opportunities for nanomaterial-based products to have clinical impact in some areas, such as in wound care (which is a priority in Canada and globally), as well as in diagnostics, but broad impact is unlikely in the next 5 years. |
Antisense oligonucleotide therapies | A therapy that uses short, synthetic oligonucleotides (i.e., DNA or RNA molecules) that target specific RNA and affect protein expression or function. These therapies are used to treat genetic disorders, neurologic conditions, and infectious diseases.216,217 | Participants discussed that antisense oligonucleotide therapies have advanced significantly over the past decade, with multiple products already available for clinical use. The number of patients who could potentially benefit from these therapies is large, given the wide range of possible disease targets, but participants were cautious about expectations for a major breakthrough in the near term, as these therapies have been in development for many years without yet achieving transformative clinical impact. |
Direct cell reprogramminga | Direct cell reprograming (also known as transdifferentiation) is a therapeutic approach that aims to convert mature, differentiated somatic cells directly into another mature functional cell type to restore or replace cell populations lost or damaged by disease.218 Unlike pluripotent approaches, direct reprogramming does not involve reverting cells to an intermediate pluripotent state.219 Direct cell reprogramming can be induced through several strategies, which generally involve introducing or upregulating key exogenous transcription factors that are important for the development of cellular identity and function.220,221 Clinically, these therapies remain experimental and are in early stages of development, with ongoing research exploring their potential for treating cardiac conditions and neurodegenerative disorder.222-224 | Participants viewed direct cell reprogramming as a secondary therapeutic approach that would likely be explored only after simpler or more established cell-based therapies have been tried and proven ineffective, too costly, or unsuitable. Its development and application are expected to vary by indication, with some areas (such as neurodegenerative disorders) potentially pursuing these strategies earlier. Clinically, this field remains far from implementation, and it is expected to take considerable time before achieving meaningful impact. |
Growth factor therapies | Growth factors are biological molecules (often proteins) that interact with specific cellular receptors to regulate cellular activities related to cell growth, proliferation, and differentiation.225 Growth factor therapies use these molecules to promote tissue repair and support healing in conditions such as chronic wounds, musculoskeletal injuries, and cardiovascular disease.226,227 | Participants agreed that growth factor therapies are a mature and well-established area, with many products already available for clinical use that have generally strong safety profiles. The mechanisms of action for these therapies are well understood (e.g., which receptors they bind), and existing regulatory and assessment frameworks are well developed, making this item less suitable for inclusion on the Watch List. Although Canada is well positioned to contribute to global supply of these therapies, participants noted that some growth factor therapies have been on the market since the 1980s, and that this is not necessarily an area with recent major clinical advancements. Ongoing challenges include high manufacturing costs and stability of formulations, and 1 participant suggested that emerging therapeutic approaches, such as gene or antisense oligonucleotide therapies, may soon displace growth factor therapies for some indications as they could be more effective at lower costs. |
Mitochondrial transplantation | Mitochondria are organelles present in human and most eukaryotic cells that are primarily responsible for production of energy for the cell. Mitochondria regulate various cellular processes, including cell metabolism, cell reproduction, cell death, and the immune response.228 Mitochondrial transplantation involves introducing healthy mitochondria from a healthy donor or unaffected part of the body and transferring them into injured cells to restore their function. This can slow down disease progression and organ injury, thereby improving patient outcomes. Currently, it is being considered as a treatment for various illnesses, including metabolic diseases, ischemic heart disease, ischemic stroke, and osteoarthritis.229-233 | Participants discussed that while mitochondrial transplantation is an exciting area with lots of future potential, it remains in the early stages of development and will require much more research before broad adoption. Some near-term potential was identified for metabolic diseases, particularly rare conditions such as Pearson syndrome, for which treatment options are limited. Key challenges include its relatively short duration of effect and significant safety concerns for both autologous and allogenic sources of mitochondria, including risks of sepsis and inflammation. |
Organoids | Organoids, often referred to as “mini-organs,” are 3D cell cultures grown in the lab from stem cells. These cells self-organize into structures that resemble the cell types, tissue structure, physiological function, and anatomic features of the corresponding organ.234 Researchers have generated organoids that mimic the brain, heart, lungs, kidneys, pancreas, skin, stomach, liver, blood vessel, and intestines.235 Organoids can be used in biomedical research to model the progression of diseases, test the effects of medications that are under development, provide human-like alternatives to animal testing, and support the development of personalized therapies, such as patient-specific tumour treatments. By allowing researchers to model human biology more directly, organoids can be useful tools for understanding how diseases develop and help guide the design of new therapies. For instance, heart organoids can be used to model the progression of cardiovascular disease, allowing researchers to understand its stages of progression and be able to obtain new insights on how to prevent and treat it.236 As organoid technology advances, they could 1 day serve as an alternative source for organ or tissue transplantation.237 | Participants noted that organoids are currently used primarily as a research tool for studying biological processes, modelling disease, and supporting drug discovery and safety testing. The technology is expected to have transformative impact on the regulatory process for new drugs by reducing reliance on traditional animal testing. However, organoids are still in the early stages and not yet suitable for translational or clinical applications in patients. Consequently, while organoids are scientifically important and hold long-term potential, participants agreed they are less timely and not a priority for inclusion in the current Watch List. |
Secretome therapies | Secretome therapy is a form of cell-free treatment that takes advantage of the therapeutic potential of substances naturally produced by cells into their environment, collectively known as the secretome. The components of the secretome include proteins, free nucleic acids, lipids, exosomes, and extracellular vesicles. These substances play a role in important cellular processes such as tissue repair, immune system regulation, and inflammation control.238-240 | Participants discussed that secretome therapies remain in the early stage of development. While promising effects have been reported in some early clinical trials, including for the treatment of dry eye disease, the underlying mechanisms are poorly understood, and it is often unclear which components of the secretome are responsible for the observed benefits. Standardization of products is a major challenge, as the composition of secreted products can vary widely between cell batches, even when using the same cell type, making consistent manufacturing difficult. Although production costs are relatively low and manufacturing methods are similar to those used for growth factor therapies, participants agreed that meaningful clinical or commercial progress is unlikely within the next 5 years. Regulatory frameworks for complex or composite biologic products of this kind are still evolving, which may limit translation. |
Xenotransplantation | Xenotransplantation is the process of transplanting, implanting, or infusing living cells, tissues, or organs from 1 species to another. Its development, particularly for animal-to-human applications, is driven by the imbalance between the demand for and supply of human organs for transplantation.241 Historically, xenotransplantation has had limited clinical viability due to persistent challenges with immune rejection and the risk of transmitting infections from the graft to the human recipient (i.e., xenozoonoses), obstacles that have remained despite centuries of research.242,243 Recent advances in genetic engineering of animal donors, along with strategies to modulate recipient immune responses, have improved the potential of xenotransplantation as a regenerative medicine approach for conditions such as organ failure, diabetes, and Parkinson disease.242 | Participants were divided on the potential for xenotransplantation within the next 5 years. Some felt that much more research is needed before it could be applied clinically, while others believed it could be available sooner. Cardiac valves derived from animal tissue are already used clinically, though they face challenges related to durability and a high risk of immune rejection. Whole organ xenotransplantation faces similar, and even greater immunological and physiological challenges, as maintaining long-term survival of transplanted tissues remains difficult. One potential exception is in the treatment of diabetes, where transplantation of insulin-producing pancreatic cells from animals may be a viable option. Recent breakthroughs, such as the first pig-to-human heart transplant performed in a patient with end-stage heart disease,244 have renewed interest in this field. Participants noted that Canada is well positioned to contribute through its strong veterinary medicine programs and academic expertise, which could support continued innovation. However, several ethical considerations were raised, including concerns about animal welfare and the potential transmission of animal pathogens that could create public health risks, which will require careful consideration alongside scientific progress. |
RNA = ribonucleic acid.
aThis item was originally titled “cell reprogramming” in the initial 25-item list; however, in response to workshop participant feedback, it was retitled “direct cell reprogramming,” and we clarified that that therapies using pluripotent stem cells derived through reprogramming techniques were considered under “stem cell therapies.”
Table 3: List of Issues Not Included in the Watch List
Issue | Description | Insights from the workshop |
|---|---|---|
Informed consent | Regenerative medicine technologies present unique challenges to the informed consent process for both patients participating in clinical research and those receiving treatments as part of routine clinical care, due to their complexity. One example is the challenge arising in the context of 3D bioprinting, where the technical complexity of the biofabrication process makes it difficult to clearly explain procedures to patients, potentially limiting the quality of consent. The highly personalized nature of regenerative medicine treatments also complicates conversations on their risks and potential benefits, since outcomes can vary widely between individuals.123 For some regenerative medicine interventions, such 3D printed bioimplants, there may be risks for side effects that are unforeseen at the time of implantation, which patients need to be made aware of while obtaining consent.245 Similarly, cell-based interventions or implanted technologies may result in irreversible bodily changes, making withdrawal of consent during treatment or trials impossible.150 Gene therapies introduce further ethical considerations. These include the possibility that gene therapies may have unintended effects on germline cells, which may impact future generations who cannot provide consent.246,247 Additionally, the inclusion of children in gene therapy clinical trials raises considerations around the appropriateness of delaying irreversible interventions in children until they have decision-making capacity to do so on their own, especially when the therapeutic risks and benefits aren’t fully known.248 | Participants agreed informed consent is an important process but not unique to regenerative medicine. It is already well supported by established frameworks and therefore does not require focused attention for the field to continue advancing. However, 1 participant noted that the consent forms are often lengthy, written in complex legal or technical language, and difficult for both investigators and participants to navigate. This can make it challenging to ensure that patients fully understand the information presented to them. Improving the clarity and accessibility of consent materials, such as through the use of plain language, was identified as an area that could strengthen the consent process. |
Privacy and confidentiality | The privacy and confidentiality of patients are important considerations in all medical and research settings. Regenerative medicine therapies introduce unique challenges that must be addressed to uphold these principles. For example, digital scans and models used in 3D printing represent sensitive personal data that may be difficult to fully anonymize, as they can show highly personal characteristics.150 Similarly, genetic data collected during gene or stem cell therapies may include identifiable information, such as familial connections and health information.249 There is a risk that this information could be linked back to individuals, potentially leading to discrimination (e.g., in employment or insurance) or emotional harm (e.g., stigma, stress, anxiety).249 | Discussions around privacy and confidentiality acknowledged that these principles are already deeply embedded in Canada’s research and health care systems. Participants noted that robust frameworks and institutional review board processes provide comprehensive oversight for protecting participant information. However, they also discussed how overly stringent or inconsistently interpreted privacy requirements can sometimes create unintended barriers to research. For example, in some jurisdictions, retrospective chart reviews may require re-consenting participants before their data can be analyzed, which may delay studies and limit the generation of new evidence. Participants stressed the importance of balancing privacy protections with the need to enable responsible research that benefits patients and health systems. Overall, they agreed that while privacy and confidentiality are important considerations, there is a growing need to shift the conversations toward viewing health data as a strategic asset that, when governed responsibly, can accelerate innovation and improve care delivery (including by enabling the development and implementation of AI applications in health care, which require access to robust, high-quality data). |
Ethical issues with the use of biological materials | Ethical issues arise around the use of cells and tissues in regenerative medicine. Patients and donors providing cells or tissues should be fully informed about how these materials will be collected, stored, analyzed, accessed, destroyed, and for which purposes they will be used.250,251 Biological materials hold different meanings and values across cultural groups, and these processes should respect the needs and values of diverse groups.252 In Canada, there are also additional considerations regarding the sovereignty and governance of biological samples from Indigenous Peoples, who have specific values and rights that must be upheld in research and clinical applications.253,254 Ethical issues also extend to regenerative medicine products derived from nonhuman biological sources. For example, individuals may be uncomfortable or reject therapies sourced from certain animals (e.g., porcine) for cultural or religious reasons.245 | Workshop discussions briefly touched on the ethical issues with the use of biological materials, recognizing it is an important but well-managed issue. Participants noted that comprehensive legal and regulatory frameworks already govern how human and animal tissues are sourced, stored, and used in research and health care. |
Diversity and equity in research | Many regenerative medicine technologies are personalized treatments tailored to an individual's unique biological profile, including their genetics, lifestyle, and other factors. To ensure these therapies are effective and safe for everyone, clinical trials should involve participants with diverse characteristics, experiences, and perspectives. Furthermore, equitable access to research participation helps to ensure individuals who are living with the condition under study or who could benefit from its outcomes have fair opportunities to participate in clinical trials to access investigational therapies and contribute to scientific progress.255,256 | Participants discussed that diversity and equity considerations are embedded across university and research institutions in Canada, but continued attention is needed to maintain and strengthen progress. They noted that limited data are available on the participation of diverse groups in clinical trials, which could lead to unrecognized differences in treatment effects across populations.257 Participants emphasized the importance of continuously monitoring representation through an intersectional lens, considering factors such as sex and gender, age, ethnicity, and the unique barriers to care and research participation experienced by Indigenous Peoples, newcomers to Canada, and individuals of varying socioeconomic status. |
Risks of unregulated or unproven treatments | In some cases, public enthusiasm for regenerative medicine technologies has outpaced scientific evidence supporting them.258 This excitement has been taken advantage of by businesses that market unlicensed and unproven interventions as regenerative medicines, often through deceptive marketing practices for monetary benefit.259 In Canada, this includes the provision of unproven autologous cell therapy products that have not been authorized by Health Canada, despite the agency’s clarification that such products meet the definition of drug in the Food and Drugs Act.260 There has also been growing interest in stem cell therapies as a treatment for erectile dysfunction, coupled with deceptive marketing, despite limited scientific evidence and consensus.261 Similarly, unproven stem cell interventions were promoted as interventions for the prevention or treatment of COVID-19.262 Such practices put patients at risk of physical and financial harms.260 | Concerns about unproven or unlicensed regenerative medicine therapies remain relevant, even within Canada’s strong regulatory environment. Participants acknowledged that while Health Canada has robust systems in place, enforcement is often limited unless patients file complaints. Misinformation continues to circulate, and patients may still seek unregulated treatments abroad, sometimes returning with health complications. Participants discussed the need to balance patient autonomy and the right to pursue experimental options with the responsibility to ensure access to accurate, evidence-based information. Although this issue continues to create risks for public trust, it was viewed as not as important as other issues identified on this Watch List. |
Note: The initial 25-item list included 11 issues. Following the workshop discussion, we merged 2 issues: “challenges in generating evidence” with “alternative models for research, product development, and regulation.” Participants agreed these were closely related and best represented as a single issue. The combined issue was prioritized and included in the Watch List.
ISSN: 2563-6596
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