Cell therapies for type 1 diabetes (T1D) are coming. These therapies replace destroyed beta cells with new cells that make insulin and protect them so that they can function for a long time. Cell therapies are complex products: many in development contain stem cell-derived cells, some with genetic modifications and/or a device to implant and protect them. Not only are the products themselves complex, but the need to surgically implant them means they must be delivered at a well-equipped site by a trained health care team.
These are unlike traditional drugs or medical devices. Their complexity means that Canada’s current regulatory, reimbursement and healthcare delivery systems may not be equipped to handle them. As the first cell therapies for T1D are approaching regulatory approval, we must act now to ensure our systems are ready. Research and clinical trials are revealing increasingly exciting results showing that these therapies can provide transformative benefit to people living with the disease.
Recognizing this urgency, Breakthrough T1D Canada, the Stem Cell Network and Shift Health convened a two-day workshop in June 2025 entitled Preparing Canada’s Health System for Regenerative Medicines and Advanced Therapeutics: Cell Therapies for Type 1 Diabetes. This event brought together over 30 cross-sector participants — researchers, clinicians, biomanufacturing experts, people with T1D, industry experts, funders, payers, and representatives from Health Canada and the Canadian Drug Agency – to identify barriers and co-create actionable solutions to accelerate Canada’s readiness for T1D cell therapies. As outlined in the full report, the workshop focused on 5 key areas:
1. Translating research into real treatments. Inadequate funding, lack of supports for commercialization, and inadequate clarity regarding manufacturing standards for T1D cell therapies were identified as key barriers. Among solutions identified, the group concluded that the most impactful, feasible action in this area would be to demonstrate the comprehensive value of T1D cell therapies – including socioeconomic impacts – to increase funding for research and associated activities.
2. Regulatory approval and assessment. Regulatory processes are complex, challenging to navigate, and lack economic models to accurately capture the impact of cell therapies. Moreover, regulatory decision-making and assessments may not currently consider what matters most to people with T1D. Crucial to addressing barriers in this area will be creating mechanisms for innovators to navigate regulatory steps and integrating the voices of people with T1D throughout the process.
3. Coverage for new treatments: Canada’s reimbursement models are not designed to cover complex products like cell therapies. To enable and ensure access to these therapies for people with T1D, manufacturers and payers must engage early to share robust evidence about cell therapies, including a full picture of the unmet need for people with T1D informed by the community, and explore new reimbursement models that make sense for cell therapies.
4. Delivering cell therapies in Canadian health systems. Few Canadian hospitals are ready to deliver T1D cell therapies, care teams need specialized training, and public awareness is low. A key solution is to establish strategically located centres of excellence in T1D cell therapies – hubs where trained teams can provide coordinated care, support, and monitoring for patients receiving these therapies.
5. Combating misinformation and disinformation. Misleading narratives, often amplified by mainstream media, can distort perceptions about safety and effectiveness and fuel mistrust of a therapy that could be transformative for the right patient. Clear, accurate, and accessible communication about T1D cell therapies is essential to build awareness, understanding and confidence in the T1D community and the public.
As highlighted at this Canadian workshop, many challenges remain to bringing cell therapies to people with T1D in Canada and beyond and addressing them will require working across several domains – research, clinical trials, regulatory, reimbursement, and clinical adoption. To address this need for coordinated effort, last year Breakthrough T1D introduced a global initiative called Project ACT (Accelerating Cell Therapies) – our game plan to dramatically speed development and access to cell therapies for people with T1D around the world.
Canada is where insulin was first discovered, and where T1D treatment transplanting islet cells known as the Edmonton Protocol took place. The country’s legacy and talent in cell therapies positions us as a key driver of success in Project ACT. To realize this potential, we must continue to invest, innovate, raise awareness, and convene partners. With your support, we can help more people with T1D gain access to these life-changing and therapies and get us closer to cures for T1D.
Read the full workshop report.
Read more about our global initiative, Project ACT.
