By Fennie Easton van der Graaf, Jefferies Lab Alum
This is a two-part blog about unapproved stem cell therapies in Canada. This second part covers the lack of regulatory clarity in the Canadian context that allows illegal clinics to exist, and the funding challenges that slow down legitimate stem cell products from reaching the Canadian market.
Read Part 1 of this blog here: Stem Cell Therapies in the Canadian Market (Part 1): The Challenge of Unapproved Treatments
Lack of regulatory clarity in Canada
Changing our healthcare system to accept costly stem cell treatments is an unlikely transition anytime soon, so we have to ask: why are stem cell treatments so expensive, and can they be made cheaper? To answer this, we can explore why stem cell therapies are generally “under development” in Canada, and how this relates to Health Canada regulations, funding available for stem cell therapy research, and how researchers develop these treatments.
In the past year or so, Health Canada has regulated stem cell therapies as drugs under the Food and Drugs Act1. Cell therapies that originate from the patient’s own cells (autologous), with the same function for the donor and recipient (homologous), and are considered minimally manipulated require Part C Division 5 (Drugs for Clinical Trials in Humans) and Division 8 (New Drugs) of the Food and Drug Regulation (FDR). However, it is still unclear what defines a “minimally manipulated” stem cell therapy. According to Chisholm et al. 2019, Health Canada doesn’t list processing activities that define minimal manipulation, nor do they provide any examples of homologous stem cell therapies2. Since therapies that are not minimally manipulated require several more quality checks and clinical trial requirements than the alternative, researchers are quite motivated to prove that their stem cells are minimally manipulated. Health Canada also needs to clarify regulatory guidelines regarding autologous stem cell therapy treatments that are processed and administered using equipment that has been authorized under a medical device license. In a position paper, Health Canada suggests that physicians might assume that since the equipment used to manufacture the stem cells are Health Canada-approved, the stem cell products themselves have also been approved1. The position paper continues to state that unless a device has received specific therapeutic indication for its cell therapy product, FDR will apply to the product.
Changing our healthcare system to accept costly stem cell treatments is an unlikely transition anytime soon, so we have to ask: why are stem cell treatments so expensive, and can they be made cheaper?
This lack of clarity in Canada’s stem cell regulatory framework creates loopholes where physicians can provide unapproved stem cell therapies. However, this urgent regulatory issue is also confusing researchers and costs them more time and funds to try and comply with all possible requirements that could apply to their therapy, in order to achieve approval. Von Tigerstrom et al 2012 conducted a survey to assess Canadian researchers’ experience with stem cell therapy regulation, and found that many were frustrated with the policy’s transparency and adaptability to new treatments3.
Funding challenges in Canada
Increasing funding for stem cell research is essential for driving therapies into the market, since every step in Canada’s complicated regulatory process is expensive. Due to heavy funding in 2018, the 2019 budget did not provide new funding to basic research projects through CIHR4. In March 2019, Ottawa signaled support for the nonprofit organization Stem Cell Network (SCN), with a multi-year $18 million investment5. However, most of the 2019 science budget was allocated to Genome Canada, TRIUMF, and two cancer charities, reflecting a shift away from stem cell research funding. In May 2019 the Progressive Conservatives in Ontario decided to stop its $5 million annual investment in the Ontario Institute for Regenerative Medicine to allocate it to direct patient care efforts6. Overall, Canadian politics has a mixed attitude to funding stem cell therapy, but funding for healthcare is a current priority and hopefully this will motivate Canada to continue to invest more in this field.
Dr. Kaul presenting at the Centre for Blood Research Summer Seminar Series (August 2019). Photo Credit: Zandstra Lab
Research in stem cell therapy requires a stem cell source and animal models, which can be costly, ethically challenging, and time consuming to obtain and study. A faster, cheaper, ethical, and quarantine-friendly approach is to start with cell interaction modelling. Through modelling experiments, time and resources can be saved during later stage in vitro and in vivo stem cell studies.
Dr. Himanshu Kaul in the Zandstra Lab develops mathematical models that could eventually test efficacy of stem cells even before they enter in vitro cell culture experiments.
“Computational models allow us to quantitatively understand how different cells interact with each other in the presence of chemical [molecules] and physical [forces] signal to yield tissues and organs. As such, mathematical models can be utilised to understand how addition of stem cells into a diseased system can enhance repair and understand the side-effects,” says Dr. Kaul.
By educating more stem cell researchers on modelling methods, stem cell research could operate more efficiently at a lower cost, and more efficiently.
What can be done to strengthen stem cell regulations and accelerate legal treatments into the Canadian market?
I think that policy makers, physicians, and stem cell researchers hold the most responsibility to change the use of stem cell therapies in Canada.
To remove illegal stem cell treatments from the Canadian market, immediate action is needed. Health Canada must continue to suspend clinics offering unregulated treatments, working with organizations like the Competition Bureau to regulate stem cell marketing. To introduce legal stem cell treatments into the Canadian market requires systemic change. Policy makers need to clarify stem cell therapy regulations, particularly for “minimally manipulated” therapies, and increase funding for stem cell therapy. Physicians need to deter their patients away from unapproved clinics and educate their patients better on stem cell therapies. Researchers need to become more standardized and efficient when developing stem cell therapies, by considering approaches such as computational modelling before in-lab experiments.
Overall, stem therapy has the potential to treat a variety of diseases, but we must work together to increase its accessibility, affordability, and trustworthiness for Canadian patients. If you come across any unsafe or non-efficacious health products, then let Health Canada know via their complaint form.
References
1 Canada, H. (2020, January 17). Health Canada Policy Position Paper – Autologous Cell Therapy Products. Retrieved December 12, 2020, from: https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/cell-therapy-policy.html
2 Chisholm, J., Ruff, C., & Viswanathan, S. (2019). Current state of Health Canada regulation for cellular and gene therapy products: potential cures on the horizon. Cytotherapy, 21(7), 686–698. https://doi.org/10.1016/j.jcyt.2019.03.005
3 von Tigerstrom, B., Nguyen, T. M., & Knoppers, B. M. (2012). Regulation of Stem Cell-Based Therapies in Canada: Current Issues and Concerns. Stem Cell Reviews and Reports, 8(3), 623–628. https://doi.org/10.1007/s12015-012-9360-0
4 Owens, B. (2019). Canada budget overlooks basic research. Nature, 567(7749), 443–444. https://doi.org/10.1038/d41586-019-00852-0
5 Willemse, L. (2019). Canada’s Stem Cell Network Welcomes Renewed Federal Commitment for Stem Cell & Regenerative Medicine Research : Stem Cell Network. Retrieved from Stemcellnetwork.ca website: https://stemcellnetwork.ca/canadas-stem-cell-network-welcomes-renewed-federal-commitment-for-stem-cell-regenerative-medicine-research/
6 Crawley, M. (2019, May 16). Ford government scraps funding for stem cell research. Retrieved from CBC website: https://www.cbc.ca/news/canada/toronto/doug-ford-stem-cell-ontario-institute-regenerative-medicine-1.5137512