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How the Stem Cell Network Is Accelerating Regenerative Medicine from Lab to Clinic in Canada

How the Stem Cell Network Is Accelerating Regenerative Medicine from Lab to Clinic in Canada

Breakthroughs in regenerative medicine are accelerating, but ensuring that these therapies reach patients in an accessible and affordable way remains a challenge for health systems worldwide.

In Canada, these challenges are particularly pronounced, prompting the Stem Cell Network to launch a focused effort on access, affordability and adoption.

In an interview with Xtalks, Cate Murray, the organization’s President and CEO, said their initiative is designed to be holistic and modernize how regenerative medicines move through the health system.

As regenerative medicine advances from the lab to the clinic, Canada risks falling behind in translating its own scientific breakthroughs into accessible therapies for patients, according to Murray.

To address this gap, last year the Stem Cell Network launched a health policy initiative focused on access, affordability and adoption, or “AAA,” aimed at modernizing how regenerative medicines, particularly Canadian-developed cell and gene therapies, move through the country’s health system.

While the science has moved dramatically forward, “our regulatory, reimbursement and adoption systems were built for an older paradigm, small molecules, medical devices and large manufacturers and pharma. When developed, they did not necessarily take into consideration advanced or personalized therapies,” said Murray.

From Discovery to Delivery

Founded nearly 25 years ago, the Stem Cell Network is a national not-for-profit that brings together academic researchers, trainees, bioentrepreneurs, clinicians and industry partners to translate regenerative medicine research into real-world therapies.

While Canada has played a foundational role in the field, with stem cells first discovered by Canadian scientists James Till and Ernest McCulloch in the 1960s, Murray says structural barriers continue to slow progress.

Canada’s healthcare system, with multiple payers and complex regulatory and health technology assessment pathways, poses particular challenges for novel therapies with respect to adoption and reimbursement. These hurdles can delay trials, increase costs, hinder health system adoption, and prevent Canadian biotechs from growing and staying in Canada. Today’s system requires that Canadian companies sell or license their innovations to global pharmaceutical companies, only for those same therapies to return to Canada at higher price, and years after they have entered other markets.

“We invest heavily in research with taxpayer dollars,” Murray said. “But on the other hand, our regulatory, access and health adoption systems are putting us at a disadvantage by preventing translation due to the timelines and costs associated with working through those processes. Those issues, combined with narrowly scoped reimbursement requirements prevent access to patients and negate the investments Canadians have made through their tax dollars.”

Key Barriers and Proposed Solutions

For the inaugural AAA workshop in June 2025, the Stem Cell Network convened roughly 40 stakeholders from across Canada’s life sciences and healthcare ecosystem for a two-day workshop to identify bottlenecks and practical solutions. One major takeaway from the meeting was that Canada’s regulatory system remains opaque, resource-intensive and poorly suited to academic and early-stage biotech innovators.

Among the proposed solutions is the creation of a non-profit regulatory “concierge” pathway, a hands-on support system to guide researchers and small biotechs through processes such as clinical trial applications, investigational new drug submissions and early regulatory engagement. Additionally, setting in place Centres of Excellence for CGTs across Canada that support clinical trials, training, education and ongoing support for patients was determined to be a significant step forward for modernizing our national system.

“Our researchers are trained to do science, not to be regulatory experts,” Murray said. “They need people who can roll up their sleeves and help them navigate the system efficiently.”

The initiative also calls for prioritized regulatory pathways for Canadian-developed cell and gene therapies, with expedited timelines to help domestic innovations compete globally. Without such reforms, Murray warned, many early-stage companies may struggle to survive without partnering with large pharmaceutical companies.

“Pharmas have a very important place in our ecosystem as they know how to scale, manage supply chains and bring great value and innovations. However, Canada needs to develop its own thriving life sciences sector, and we can’t do that with the current state of play,” Murray explained.

Even after national price negotiations, therapies must still be adopted province by province, and hospitals may lack the infrastructure or training needed to deliver complex regenerative treatments.

These therapies aren’t like small molecule drugs; they require specialized manufacturing, handling, storage and care pathways, which means hospitals and clinicians need time, education and incentives to prepare.

The Stem Cell Network is advocating for a pan-Canadian, Canada-first procurement approach, alongside investments in clinician education and hospital readiness, to ensure Canadian innovations are adopted domestically before being exported abroad.

The Stem Cell Network hosted a second AAA workshop in June 2026 and will release a report with findings in the coming months.

Partners in Translation

Central to the Stem Cell Network’s strategy is its emphasis on partnerships across academia, biotech, manufacturing and policy. Murray described a collaborative, trust-based approach, one that prioritizes co-development over top-down directives.

“We don’t fund and forget,” she said. “We grow and follow our research projects as they develop.”

This includes supporting early-stage biotechs through commercialization training, investor exposure, process development guidance and connections to biomanufacturing partners, helping researchers “start with the end in mind” and avoid costly dead ends later in development.

With Stem Cell Network’s 25th anniversary this year, Murray said her priorities include expanding support for translational research, investing in Canadian biotechs at the pre-seed and seed stages, and providing actionable leadership on access, affordability and adoption.

“Regenerative medicine offers durable, long-term solutions,” she said. “It’s a game changer for patients and families.” The question now is whether Canada will fully seize the opportunity or let it slip away.