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Canadian clinics marketing unapproved stem cell treatments
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A total of 30 Canadian businesses are marketing stem cell interventions at 43 clinics throughout the country that are neither approved by Health Canada nor covered by provincial health insurance plans, according to findings published in Regenerative Medicine.
“I’m concerned when businesses charge thousands of dollars for stem cell interventions that are not evidence-based,” Leigh Turner, PhD, an associate professor at the University of Minnesota Center for Bioethics, and a Canadian citizen, said in a press release. “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.”
According to the release, of the 43 clinics offering the interventions, 24 are in Ontario, eight are in British Columbia, six are in Alberta, three are in Quebec and one each is in Nova Scotia and Saskatchewan.
The most common uses marketed by the companies and clinics were related to orthopedic and musculoskeletal indications, pain relief and sports-related injuries. One company in British Columbia currently markets stem cell treatments for a “wide range of disorders,” such as ALS, Parkinson’s disease, stroke, multiple sclerosis, scleroderma, muscular dystrophy, post myocardial infarction and erectile dysfunction, according to the press release.
Most of the products sold are autologous stem cells, with 22 companies purportedly deriving them from adipose tissue, 15 companies obtaining them from bone marrow, and two reportedly sourcing the cells from peripheral blood. In addition, one company markets amniotic-derived stem cells, as well as those harvested from umbilical cords, the press release said. Most of these businesses also advertise platelet-rich plasma procedures.
“I’m critical of the advertising claims made by many of these companies,” Turner said in the release. “In general, they exaggerate likelihood of therapeutic benefits and minimize possibility of complications.”
According to Turner, the laws governing the marketing and sale of such therapies constitutes a “regulatory gray zone.” Canadian businesses who offer minimally manipulated autologous stem cells used for homologous purposes are not required to obtain authorization from Health Canada before going to market; however, the definitions of “minimally manipulated” and “homologous purposes” are unclear and not specified by federal regulations.
In the United States, the rise of the direct-to-consumer, unlicensed stem cell market has resulted in a growing number of patients who have reportedly been harmed by such treatments, the release stated.
Health Canada has, to date, not taken regulatory action against any of the businesses, clinics or clinicians involved in the marketing and sale of these stem cell products. According to Turner, this “regulatory oversight” will likely result in an increase in Canadian companies offering these treatments.
“In Canada, as in other countries, it is common to find clinics selling purported stem cell treatments operating in regulatory gray zones,” Turner said in the release. “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.” – by Jason Laday
Disclosure: Turner reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.
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Turner L, et al. Regen Med. 2018;doi:10.2217/rme-2018-0033.
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