Canadian clinics are marketing unproven stem cell treatments. Also – they’re not yet approved by Health Canada

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Stem Cell Research. The Mayo Clinic.

An interesting study to report on, published in Regenerative Medicine Thursday, Sept. 27th, is casting a light into the world of stem cell therapy. For or against – it could become one of the great ethical questions of our lifetime. Of course, there is research for good. And that is always the hope.  Treatments that were unheard of even a decade ago, are offering hope. A new empirical study examines Canadian companies and clinics engaged in direct-to-consumer online marketing of stem cell treatments. Bioethics is at the heart of the matter.

Embryonic stem cells (ES cells or ESCs) are pluripotent stem cells derived from the inner cell mass of a blastocyst, an early-stage pre-implantation embryo.[1][2] Human embryos reach the blastocyst stage 4–5 days post fertilization, at which time they consist of 50–150 cells. Isolating the embryoblast, or inner cell mass (ICM) results in destruction of the blastocyst, a process which raises ethical issues, including whether or not embryos at the pre-implantation stage should have the same moral considerations as embryos in the post-implantation stage of development.[3][4] Researchers are currently focusing heavily on the therapeutic potential of embryonic stem cells, with clinical use being the goal for many labs. These cells are being studied to be used as clinical therapies, models of genetic disorders, and cellular/DNA repair. However, adverse effects in the research and clinical processes have also been reported. (wikipedia)
Future Science Group, on Thursday, September 27, 2018, announced the publication of the peer-reviewed study that surveys the Canadian direct-to-consumer marketplace of companies advertising putative stem cell treatments for various clinical indications. “Direct-to-Consumer Marketing of Stem Cell Interventions by Canadian Businesses” is authored by Leigh Turner, PhD, a Canadian citizen and Associate Professor at the University of Minnesota’s Center for Bioethics, School of Public Health, and College of Pharmacy (MN, USA), and published in the industry-leading journal Regenerative Medicine.

In the article, Turner identifies a total of 30 Canadian businesses marketing stem cell interventions provided at 43 clinics. The province of Ontario has 24 such clinics, British Columbia has eight clinics, Alberta has six, Quebec has three, and Nova Scotia and Saskatchewan each has a single clinic marketing stem cell treatments. Since these interventions are not approved by Health Canada or covered by provincial health insurance plans, patients typically pay for such interventions on an out-of-pocket basis.

The most common indications marketed by the 30 companies were orthopedic and musculoskeletal indications, pain relief, and sports-related injuries. One British Columbia-based company markets (purported) stem cell treatments for a wide range of disorders including ALS, Parkinson’s disease, stroke, multiple sclerosis, scleroderma, muscular dystrophy, post myocardial infarction and erectile dysfunction.

Of the 30 companies, 22 market autologous stem cells derived from adipose tissue, 15 advertise autologous stem cells obtained from bone marrow, and 2 promote autologous stem cells reportedly sourced from peripheral blood. One company markets amniotic derived stem cell products and stem cells reportedly obtained from umbilical cords. Most Canadian businesses marketing ‘stem cell therapies’ also advertise platelet-rich plasma (PRP) procedures.

“I’m critical of the advertising claims made by many of these companies,” Turner stated. “In general, they exaggerate likelihood of therapeutic benefits and minimize possibility of complications.”

Canadian businesses marketing minimally manipulated autologous stem cell products used for homologous purposes are not required to obtain pre-marketing authorization from Health Canada. Precisely which autologous stem cell products fall within the scope of minimal manipulation is not clearly indicated by federal regulations. Likewise, what constitutes homologous use of autologous stem cell products is not precisely specified. Researchers have identified this space as a regulatory gap that needs to be better addressed by Health Canada.

Multiple Sclerosis Stem Cell Research. photo via Healthline.com Article: ‘Those with MS Are Cautioned About Unsafe Stem Cell Treatments’

“In Canada, as in other countries,” Turner stated, “it is common to find clinics selling purported stem cell treatments operating in regulatory grey zones. They don’t have regulatory approval for their stem cell products and, in many cases, they don’t have conclusive safety and efficacy data supporting their advertising claims.”

To date, Health Canada does not appear to have taken regulatory action against any of the 30 businesses. Likewise, there is no public evidence of any clinicians associated with these businesses being disciplined for participating in the marketing, sale and provision of purported stem cell treatments. In the absence of more robust regulatory oversight, there likely will be an increase in the number of Canadian companies advertising purported stem cell treatments.

In the USA, the emergence of a large and growing direct-to-consumer marketplace selling unproven and unlicensed stem cell interventions has resulted in a growing number of patients who have reportedly been harmed by such procedures. Whether a similar outcome will occur in Canada is as yet unclear, though there are grounds for concern that growth of Canada’s marketplace could lead to injuries, financial losses and other harms.

“I’m concerned when businesses charge thousands of dollars for stem cell interventions that are not evidence-based,” Turner said. “There’s a risk that vulnerable individuals are making decisions on the basis of inaccurate marketing claims. There’s also the possibility that some patients will suffer serious injuries as a result of receiving stem cell products that are not being adequately overseen by federal and provincial regulatory authorities. I’d like to see regulatory authorities act now, before there are reports of life-altering complications.”

Adam Price-Evans, Managing Editor of the journal Regenerative Medicine commented, “With the rapid proliferation of businesses engaged in direct-to-consumer marketing of stem cell treatments worldwide, this study provides a timely analysis of the current Canadian landscape. It aims to educate and inform the wide range of stakeholders in the field of stem cell therapeutics and I hope it will ultimately benefit patients in the future.”

Leigh Turner is an Associate Professor at the University of Minnesota Center for Bioethics, School of Public Health, and College of Pharmacy. Follow on Twitter @LeighGTurner.

 

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