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Regenerative Medicine: Are we there yet?

Co-authored by: Jen Kwiatkowski and Lisa Willemse

More than half a century ago, two Canadian researchers, James Till & Ernest McCulloch, proved the existence of stem cells. Following in their footsteps, researchers took this discovery and began to unravel an abundance of possibilities.

Today, we have a vigorous stem cell and regenerative medicine ecosystem. We can now grow, manipulate and modify stem cells through advanced technologies. For more than 17 years, the Stem Cell Network has sought to grow this sector by actively supporting the research pipeline from bench to bedside, bringing new commercial products to market and providing a framework for public policies that reflect the needs of society and the rapid advance of research. SCN has supported more than 2,500 trainees, invested $100M in research, training and outreach and leveraged $100M in partnerships.

Today, we are closer to the goal of improving the well-being of millions who are afflicted with illness, injury and chronic disease. Dr. James Shapiro at the University of Alberta and Dr. Timothy Kieffer at the University of British Columbia are leading cutting-edge clinical trials in the hopes of treating type 1 diabetes by safely delivering replacement cells to produce insulin. Dr. Freda Miller at the Hospital for Sick Children has discovered a way to repair the brain that she hopes will restore some of the functions lost after injury or as a side-effect of cancer treatment, and Dr. Lucie Germain at Laval University has developed methods to reconstruct skin and eye tissues that are being tested as replacements for people with vision loss, burns or other injuries to the skin.

These and other clinical trials taking place in Canada clearly demonstrate that the field has been successful in moving basic science closer to the clinic. Canadian ethical, legal and policy scholars have similarly made significant progress to ensure the evolving science is supported by legislative frameworks. We’ve also made strides in building manufacturing and commercial capacities to meet future demands for cell products. Does this mean that regenerative medicine has come of age?

The simple answer is no. We have come a long way but there are still more questions to be answered and problems to solve.

On the scientific side, we are just beginning to understand the complex processes that take place within and between cells that can have massive impact on how a stem cell behaves and how it might be safely manipulated for clinical use. We have really just begun to scratch the surface of what is possible in cell therapy and gene editing, for example.

Concurrently, we need to address the ethical and social issues arising from new discoveries and technologies to ensure they are integrated into evidence-based policy. There is still more work to be done in public outreach to increase basic understanding of the science and to address the prevalence of unproven therapies that are increasingly available in Canada and abroad. A critical gap remains where research funding typically ends and private investment begins: currently organizations such as the Stem Cell Network and the Ontario Institute for Regenerative Medicine have stepped in to fund early stage clinical trials, but more is needed to create an environment that is conducive to clinical activities, company creation and larger scale venture investment.

We also face challenges with support and patient access for the next generation technologies and therapies that can drive down health care costs. To do this, we need to work with a broader range of facilitators end-users including health care providers, insurers, health charities and patients. We need to increase production capacity for standardized, clinical-grade cell products and facilitate efficient transit of therapies through the regulatory system.

We are at a tipping point; with Canada’s scientific strength and supportive clinical and regulatory environment, we are poised to drive more therapies from bench to bedside. But we must invest in our future to maintain our global leadership in this sector and to realize the health and economic benefits that lie just within our grasp. Only then can we say that yes, regenerative medicine has come of age.

This blog is just one of many covering this topic as part of Signal’s third annual blog carnival.

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