New research from the University of Minnesota'sCenter for Bioethicsshows 30 Canadian businesses are marketing unproven stem cell treatments directly to consumers at 43 clinics across the country. Without new regulations and guidance, researchers say the Canadian direct-to-consumer marketplace for these purported treatments could result in patients making health-related decisions informed solely on marketing claims rather than the best available scientific evidence.
“I’m concerned when businesses charge thousands of dollars for stem cell interventions that are not evidence-based,” said Leigh Turner, Ph.D., Center for Bioethics associate professor and author of the study. “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.”
The most common treatments marketed were orthopedic and musculoskeletal indications (26 companies); pain relief (23 companies) and sports-related injuries (14 companies).
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.
An Ontario-based business advertises stem cell treatments for asthma, autism, multiple sclerosis, COPD, diabetes, erectile dysfunction, gout and other indications.
The province of Ontario has 24 clinics, British Columbia has eight clinics, Alberta has six, Quebec has three, and Nova Scotia and Saskatchewan each have a single clinic marketing putative stem cell therapies.“I’m critical of the advertising claims made by many of these companies,” said Turner. “In general, they exaggerate the likelihood of therapeutic benefits and minimize the possibility of complications.”
The interventions marketed by the 30 companies and reported in the study are not approved by Health Canada. According to Turner, in Canada and other countries, it is common to find clinics selling purported stem cell treatments operating in regulatory gray zones:
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.
What constitutes homologous use of autologous stem cell products is not precisely specified.
In an apparent reading of Health Canada guidance documents, some clinics claim that all autologous stem cell products — even those that have been extensively processed beyond the minimal manipulation standard and are not used for homologous purposes — are not subject to pre-marketing authorization by Health Canada.
“The clinics 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,” said Turner. “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.”