6 minute read
A perfect storm in regenerative medicine
By Lisa Willemse
ONTARIO
Advertisement
Clinical trials involving stem cells are increasingly common in hospitals and institutions across Ontario, focusing on severe debilitating conditions such as spinal cord injury, heart disease and autoimmune disorders. As a result, Ontario is poised to emerge as the world leader in regenerative medicine.
In the blink of an eye, or as quickly as car accidents happen, a woman is transformed from an active individual – one who drives her kids to school and sports events, works part time and manages a busy household – to one in a wheelchair, with no use of her legs and only minimal use of her hands. Life for her and her entire family is irrevocably changed.
Dr. Michael Fehlings has a vision where this change can be reversed, where such victims of spinal cord injury can regain a portion, or perhaps all of their lost function. This vision involves stem cells, which are a cornerstone of his work as a clinician-researcher at the University Health Network and play a central role in a clinical trial he is undertaking to test the safety of neural stem cells to regenerate thoracic and cervical spinal cord injuries. The first phase of the trial, sponsored by StemCells Inc., which enrolled 12 patients in Toronto, Calgary and Zurich, recently concluded and the results are now being written for publication.
The second phase of the trial is anticipated to start later this year in Toronto and other, yet to be identified, centres, and will seek to enrol participants with a cervical spinal cord injury. Dr. Fehlings and his team are excited about this second phase because of the potential impact: injuries to the cervical spine account for approximately 70 per cent of all spinal cord injuries in Canada. Such injuries often result in quadriplegia, with significant reduction in quality of life for those afflicted. “I think this could have a big impact because even small amounts of regeneration can influence one or two segments of the spinal cord and if we can achieve this, participants will regain the use of their hands, which can have a huge impact on recovery,” said Dr. Fehlings. “To put this in context with the first study, an equivalent improvement on the thoracic spinal cord might not be detectable at all by the patient or the physician. So the impact here for the cervical spinal cord is enormous.”
That this trial can take place in Ontario and possibly improve the outcomes of Ontario patients is important to Dr. Fehlings and his team. “It’s a significant reflection on Ontario’s vision for the future that the province recognizes the potential of regenerative medicine and is investing in the creation of a biotech environment that supports clinical translation and commercialization of research,” he said.
The trial is one of several with connec-
of research.” — Dr. Michael Fehlings
ONTARIO
tions to the Ontario Institute for Regenerative Medicine (OIRM), which was formed in 2014 to coordinate Ontario’s research, clinical, and commercial efforts in the development of stem cell-based products and therapies. OIRM has focused its energies in advancing stem cell and regenerative medicine therapies for a range of debilitating diseases for which current treatments fall short. These include autoimmune disorders and diabetes, as well as diseases or injuries that affect musculoskeletal, cardiovascular, vision, neurological and blood systems.
OIRM, and its partner, the Centre for Commercialization of Regenerative Medicine (CCRM), are leading a convergence of advanced research, an expanding clinical infrastructure and commercial opportunities in Ontario that has summoned a new era for regenerative medicine – one that is increasingly focused on bringing new therapies to the clinic.
Consider that, as recently as 10 years ago, the announcement of a stem cell clinical trial for a condition other than cancer would have been front page news across the globe. While many such announcements are still newsworthy, the steady increase in new stem cell trials has made them a much more common occurrence – in Ontario alone this year, there are at least eight such studies underway or scheduled to begin. Taken together, these studies involve 11 institutions and two Ontario-based companies in London, Ottawa and Toronto, and will enrol approximately 650 patients.
This surge is hardly surprising in light of the commitment and motivation one finds in the province. Ontario ranks exceptionally high internationally in stem cell and regenerative medicine research. Infrastructure, in terms of facilities and a supportive regulatory environment also plays an important role.
“If you’re working in regenerative medicine, either as a researcher, clinician or entrepreneur, Ontario is an ideal place to be right now,” said Dr. Janet Rossant. “We’ve got a perfect storm of support and vision that promises to be transformative not just for health care, but for the economy as well.”
As the interim director for OIRM and a recent Canada Gairdner Wightman award winner, Dr. Rossant knows about building a supportive environment. She built her own lab from a small space in an old refrigerator factory and moved it to one of the most recognized institutes in the world, SickKids, to conduct research in early development. In the process, she fostered the careers of several promising young researchers, while helping to cement ties between labs across the country, and form partnerships between labs and organizations around the world.
“We have a lot of advantages in Ontario and in Canada that make us very competitive internationally,” said Dr. Rossant. “One of our greatest strengths is our willingness to collaborate and co-operate. This spirit of collaboration enabled us to first identify blood stem cells more than 50 years ago, and has led to many other significant research discoveries. But it has also made us leaders in our ability to form strong networks of people across disciplines, such as OIRM, CCRM, and also CellCAN, which is based in Montréal, but connects cell processing facilities across the country. These collaborative networks of research, commercialization and clinical infrastructure allow us to leverage smaller investments into much greater benefits.”
While much of the attention is placed on clinical outcomes, there is equal energy being placed in cell manufacturing, commercialization of intellectual property, and business development, all of which is as important as basic and applied research in realizing the vision of regenerative medicine.
One of the primary drivers of this agenda is CCRM, a commercialization hub whose mission is to support the kinds of innovative technologies, such as biomaterials development and improved cell expansion protocols that are integral to the translational arc. Notably, as part of its mission, CCRM has created an industry consortium of startups, SMEs and large corporations, currently with 45 members representing Ontario, Canadian and international organizations. Members of the consortium will be able to utilize the technological platforms being developed by CCRM in order to develop new opportunities and address bottlenecks within existing systems, thereby enabling faster, more efficient and better quality cellbased products for therapeutic purposes.
In April, the Ontario government renewed its support of regenerative medicine with a pledge of $25 million to OIRM for another five years. This commitment will bring a wealth of new knowledge that in turn can be applied to the next rounds of studies and a greater number of clinical trials for Ontario. The implications are significant: not only does this have the potential to help many people suffering with ailments such as heart disease, vision loss, Multiple Sclerosis, and spinal cord injury, it promises two-fold economic benefits, first by reducing the direct and indirect costs of health care and by opening more opportunities for business development.
To see this story online visit http://biotechnologyfocus.ca/ a-perfect-storm-in-regenerativemedicine
