By Fennie Easton van der Graaf, Jefferies Lab Alum

This is a two-part blog about unapproved stem cell therapies in Canada. This first part addresses the outbreak of unsafe stem cell treatments across Canada, why patients would seek out unapproved stem cell therapies, and some potential solutions to address the issue.

 

Canadian private clinics offering unregulated stem cell treatments

Stem cell therapy has the powerful potential to aid many patients, with several clinical trials demonstrating that stem cells could be used as safe and effective treatment options for many diseases like multiple sclerosis¹, Diabetes Mellitus², and even COVID-19³.
In Canada, stem cells are defined as unspecialized cells that could come from any organ⁴, and stem cell therapies are regulated as drugs under Health Canada’s Food and Drugs Act⁵. At the time of writing, there is only one market-approved stem cell product in Canada: Prochymal by Osiris Therapeutics⁶, which is derived from human mesenchymal stromal cells, to treat Graft versus Host Disease (GvHD). Other Canadian treatments are still in the research phase and have not been approved for market use by Health Canada.

Despite this, private clinics offering unapproved stem cell treatments have been on the rise across the country, with 43 clinics in Canada found offering such products as of 2018⁷. Without proper quality assurance processes, illegal stem cell treatments can cause patients to develop harmful complications like secondary tumours⁸, and also reduce patient trust in stem cell therapy as a legitimate treatment.

Given the rising number of unapproved clinics, it’s important to consider why patients are seeking unregulated stem cell treatments, what factors influence their choice to do so, and potential solutions to this issue. This blog, the first in a two-part series, will address these topics, while the second blog will address 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.

 

What factors drive patients to seek out unapproved stem cell treatments?

Considering the potential health complications and that treatments can cost up to $15,000⁹ out of pocket, it’s important to ask: why would someone seek out an unapproved stem cell treatment in the first place?

The answer is complicated. According to Caufield et al. 2019, unregulated treatments are widely offered in the US and Canada, but there is a lack of information about the consumers of these therapies¹⁰. An internet investigation using media and literature reports found that 35 adverse reactions or deaths worldwide were caused by stem unregulated cell therapies¹¹, though the actual number may be much higher than reported (Bauer et al. 2018). It’s possible that prospective patients are unaware of the risk associated with these treatments, or that they are aware of the risks but seek out these therapies because alternative treatments are unavailable or have lengthy waitlists. This was the case of an elderly patient in Kamloops, who had been waitlisted for several surgical treatments but sought out a $6,500 unapproved stem cell therapy from a private clinic instead, in hopes of expediting the process¹².

Part of the reason also lies in the marketing tactics used by unapproved clinics, which aggressively promote their treatments in a misleading and overly positive way. In an international study, Sipp et al. 2017 found that many providers inflate the clinical benefit of stem cells, often claiming that treatments can cure any disease. Since stem cells are associated with anti-aging properties, clinics will claim that they provide enhanced immunity, reduced pain, and overall a better quality of life¹³. Though the scientific process backing such claims is weak, such as lacking a rigorous peer-review or finding results with no statistical significance, unapproved clinics will use uncritical customer reviews and media reports to reassure prospective patients that their services are safe and efficacious. Such media articles are often cited in social media and used for patients’ crowd-funding efforts, which in turn increases the public popularity of unapproved treatments¹⁴.

 

Why would someone seek out an unapproved stem cell treatment in the first place? … Part of the reason also lies in the marketing tactics used by unapproved clinics, which aggressively promote their treatments in a misleading and overly positive way.

 

Of various healthcare providers, Ogbogu et al. 2018 found that doctors dominate the unproven stem cell market. 12 of 15 websites¹⁵ in their study that advertised unregulated stem cell therapy in Canada were provided by physicians. Only 3 of 15 of these websites mention any regulatory information, only 2 mention treatment risks, and only 1 mentions the cost of their services. This raises legal concerns because these doctors can influence patients to pay for misadvertised, unproven treatments and hence contradict consumer protection laws.

Aggressive marketing is especially relevant during the pandemic, when the public is experiencing increased health anxiety. Dr. Leigh Turner (2020) explains that unregulated stem cell clinics are preying on public fears during the pandemic, and that the desperation to treat COVID-19 — or other health complications that may increase the risk of contracting COVID-19 — have driven patients to these clinics. One example is a Colorado clinic that charges USD $3,000 per person for a viral inhibitor and immune booster to prevent COVID-19 contraction via unapproved mesenchymal stem cell exosomes¹⁶. Stem cell treatments like these, which lack rigorous scientific and approval processes, are being hyped up in the media like the Daily Mail UK, which reported on a Chinese company that experienced 100% success rate after treating only 9 COVID-19 patients with stem cells¹⁷. While treatments may have potential, there is still a giant gap between this research study and reaching market approval for stem cell therapies treating COVID-19.

 

How can Canada combat the rise of unapproved treatments?

This issue is persistent today because of Canada’s slow response to these illegal clinics¹⁸. Researchers have suggested legislative tactics for Health Canada to shut down more of these illegal clinics. Sipp et al. 2017 highlights the success of journalistic pressure on regulatory agencies by exposing clinics that offer unregulated treatments. This pressure exists in Canada, and Sipp et al. 2017 also state that stakeholder organizations should advocate for appropriate regulations and accurate media representations of stem cell therapies.

Further to this idea, Caufield et al. 2019 encourages collaboration between the Competition Bureau in Canada, the organization that prohibits advertisers from making materially false or misleading promotional representations, and the scientific community. While there is more US data than Canadian data on misleading marketing around stem cell therapies, the issue applies to both countries, because one country’s enforcement of rigorous regulations may lead to a spike in stem cell tourism in the other country with more stem cell availability. As such, international collaboration is required as well (Sipp et al. 2017). Together, scientists and the Bureau could analyze the claims of existing clinics in Canada, and then impose sanctions upon those who breach the established standard. However, an ongoing issue is that the established regulatory standard is complex and requires clarification from Health Canada, which will be discussed in Part 2 of this post.

 

Read Part 2 of this blog here: Stem Cell Therapies in the Canadian Market (Part 2): Strengthening Regulations & Moving Forward

 

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References

¹ Jafarzadeh Bejargafshe, M., Hedayati, M., Zahabiasli, S., Tahmasbpour, E., Rahmanzadeh, S., & Nejad-Moghaddam, A. (2019). Safety and efficacy of stem cell therapy for treatment of neural damage in patients with multiple sclerosis. Stem Cell Investigation, 6, 44–44. https://doi.org/10.21037/sci.2019.10.06

² Zhang, Y., Chen, W., Feng, B., & Cao, H. (2020). The Clinical Efficacy and Safety of Stem Cell Therapy for Diabetes Mellitus: A Systematic Review and Meta-Analysis. Aging and disease, 11(1), 141–153. https://doi.org/10.14336/AD.2019.0421

³ Khoury, M., Rocco, P. R. M., Phinney, D. G., Krampera, M., Martin, I., Viswanathan, S., … Weiss, D. J. (2020). Cell-based therapies for coronavirus disease 2019: proper clinical investigations are essential. Cytotherapy, 22(11), 602–605. https://doi.org/10.1016/j.jcyt.2020.04.089

⁴ Canada, Health. “Stem Cells.” Gcnws, 25 Nov. 2005, www.canada.ca/en/health-canada/services/science-research/emerging-technology/biotechnology/about-biotechnology/stem-cells-biotechnology-science-research.html.

⁵ Canada, H. (2020, January 17). Health Canada Policy Position Paper – Autologous Cell Therapy Products. Retrieved December 12, 2020, from aem website: https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/cell-therapy-policy.html

⁶ Cyranoski, D. (2012). Canada approves stem cell product. Nature Biotechnology, 30(7), 571–571. https://doi.org/10.1038/nbt0712-571b

⁷ Dillion, R. (2018, September 26). More Canadian clinics are offering unproven stem cell therapies, study finds | CBC News. CBC. Retrieved from https://www.cbc.ca/news/health/more-canadian-clinics-unproven-stem-cell-therapies-1.4838985

⁸ Office of the Commissioner. (2019). FDA Warns About Stem Cell Therapies. Retrieved from U.S. Food and Drug Administration website: https://www.fda.gov/consumers/consumer-updates/fda-warns-about-stem-cell-therapies

⁹ Crowe, K. (2019, May 18). “Stem cell” therapies offered at private clinics need to be approved as drugs, Health Canada says | CBC News. CBC. Retrieved from https://www.cbc.ca/news/health/autologous-stem-cell-bone-marrow-fat-private-clinic-health-canada-regulation-1.5141299

¹⁰ Caulfield, Timothy, and Blake Murdoch. “Regulatory and Policy Tools to Address Unproven Stem Cell Interventions in Canada: The Need for Action.” BMC Medical Ethics, vol. 20, no. 1, 6 Aug. 2019, 10.1186/s12910-019-0388-4.

¹¹ Bauer, Gerhard, et al. “Concise Review: A Comprehensive Analysis of Reported Adverse Events in Patients Receiving Unproven Stem Cell-Based Interventions.” STEM CELLS Translational Medicine, vol. 7, no. 9, 31 July 2018, pp. 676–685, 10.1002/sctm.17-0282. Accessed 24 Oct. 2019.

¹² Wallace, J. (2017, June 27). Stem-cell treatment arrives in Kamloops. Retrieved December 12, 2020, from Kamloops This Week website: https://www.kamloopsthisweek.com/news/stem-cell-treatment-arrives-in-kamloops-1.23219743

¹³ “Anti-Aging Effects of Mesenchymal Stem Cell Therapy in 2021.” www.dvcstem.com, www.dvcstem.com/post/anti-aging-stem-cells. Accessed 23 Feb. 2021.

¹⁴ Sipp, D., Caulfield, T., Kaye, J., Barfoot, J., Blackburn, C., Chan, S., … Rasko, J. E. J. (2017). Marketing of unproven stem cell–based interventions: A call to action. Science Translational Medicine, 9(397), eaag0426. https://doi.org/10.1126/scitranslmed.aag0426

¹⁵ Ogbogu, U., Du, J., & Koukio, Y. (2018). The involvement of Canadian physicians in promoting and providing unproven and unapproved stem cell interventions. BMC Medical Ethics, 19(1). https://doi.org/10.1186/s12910-018-0273-6

¹⁶ Turner, L. (2020). Preying on Public Fears and Anxieties in a Pandemic: Businesses Selling Unproven and Unlicensed “Stem Cell Treatments” for COVID-19. Cell Stem Cell, 26(6). https://doi.org/10.1016/j.stem.2020.05.003

¹⁷ West, R. P. (2020, March 18). Doctor claims stem cell injections can treat coronavirus. Retrieved December 12, 2020, from Mail Online website: https://www.dailymail.co.uk/news/article-8116881/Doctor-claims-breakthrough-stem-cell-injections-treat-coronavirus.html

¹⁸ Caulfield, Timothy, and Blake Murdoch. “Regulatory and Policy Tools to Address Unproven Stem Cell Interventions in Canada: The Need for Action.” BMC Medical Ethics, vol. 20, no. 1, 6 Aug. 2019, 10.1186/s12910-019-0388-4.