Tim Caulfield, LL.B., LL.M., FRSC, FCAHS, University of Alberta

Stanching the tide of unproven stem cell therapies

It is estimated that the global market for unproven stem cell therapies runs into the hundreds of millions of dollars each year. In Canada, at least 43 unlicensed clinics sell various skin, pain, joint and other, disease-focused, treatments to consumers, none of which are substantiated by rigorous science. Current regulatory loopholes allowing “minimally manipulated” stem cell treatments enable such clinics to flourish, while a vastly larger number of similar companies in the U.S. engage in a wide range of marketing practices to lure Canadian patients south of the border.

Timothy Caulfield, a health law professor at the University of Alberta, has tracked and criticized the practices of such clinics for nearly two decades. In 2018, he received an SCN award to address a need for recommendations on how Canada should respond to the challenges and risks posed by unregulated clinics.

“The marketing of unproven stem cell therapies is loaded with false claims and celebrity endorsements that pose a real danger to consumers, and it’s becoming more pervasive as the number of clinics increases. It’s important that the scientific community speaks out against it, and the work I’ve done with SCN support has supplied critical data and tools to make this possible.”

Caulfield’s team reviewed current laws and enforcement options that apply to marketing of unproven stem cell therapies in Canada. Their work is informing a call to action for the provincial medical colleges and a set of recommendations for governing bodies such as Health Canada that could be immediately implemented to curb unlicensed activities. More public-facing activities included the creation of a plain language Fast Facts document for publication online, several interviews in Canadian and American news media, and a feature within a social media initiative that uses art to talk about science.

Conversations continue with regulatory and policy entities, with promising signs that greater action to protect patients and consumers is imminent.