Stem Cell Research
What you should know
The use of transplantation cellular therapies (such as stem cells and Schwann cells) has generated tremendous interest and excitement for their potential to promote neuro-regeneration and restoration of function in both chronic and acute SCI. Extensive pre-clinical research has been published on cell transplantation and this continues to be one of the most active areas of scientific research in SCI. However, cost and regulatory hurdles make the clinical translation of this technology extremely challenging. Current clinical trials in this area are largely focused on determining safety and feasibility, with the hope of detecting some signal of efficacy. The completion of large scale definitive clinical trials to establish efficacy are still many years away, even for therapies that are in early safety studies now.
Rick Hansen Institute's role in stem cell research
At RHI, we acknowledge the promising potential of cellular therapies within the context of a broader neuro-regenerative strategy for SCI. However, we also recognize the challenges associated with conducting clinical trials on such cellular therapies, including the stringent regulatory requirements, the high cost of conducting the trials, and the potential ethical issues related to the source of cells and/or the recruitment of human subjects. We therefore consider clinical trials for stem cell therapies as high risk endeavours that require significant and long term resource commitment. These financial requirements are prohibitive for not-for-profit organizations such as RHI, which depend on limited-term government funding, to actively participate in cellular clinical trials.
Based on the extensive and complex regulatory requirements, cost, recruitment challenges and the general uncertainty of the potential efficacy of cellular therapies, RHI will not participate actively in the funding of human trials of these therapies at this time.
Instead, we will focus on supporting pre-clinical studies that permit a better understanding of the biology of cellular mediated repair of neural tissue, axonal growth and restoration of electrophysiological properties in the damaged spinal cord with the aim of filling the knowledge gaps in understanding cellular repair. We support pre-clinical studies that provide a better understanding of cellular repair process will help identify candidate therapies that have a greater chance of success in human trials and are a more effective use of its limited resources. While not actively funding clinical trials of cell therapies, RHI will consider opportunities to leverage existing RHI resources (e.g. informatics and/or knowledge translation) to facilitate the efforts of researchers who are engaged in such studies.
We encourage you to check out the following links for more information about cellular therapies and RHI’s role in cure-related research:
> Read RHI’s Cure Roadmap which outlines our activities and objectives for the Cure Program
> View RHI's open funding competitions related to CURE.
> RHI participated in the Health Charities Forums, led by the Canadian Stem Cell Foundation to develop a Canada-wide strategy to help advance stem cell research and development. Read more about the Canadian Stem Cell Strategy.
> Read a Letter to the Editor of the journal Spinal Cord, published in 2009 that outlines the International Campaign for Cures of Spinal Cord Injury Paralysis' position on the sale of unproven cellular therapies for spinal cord injury.
> Read an excellent global summary on the current state of SCI stem cell research, also published in 2009 by the Australia New Zeland SCI Network (ANZSCIN).
Updated 5 November 2014