Preprints

Advances in the field of regenerative medicine have allowed for the rapid development of stem cell-based therapies in the hope of treating numerous debilitating diseases. Most of these therapies are not fully ready to be administered to patients, but hundreds of businesses around the world exploit the excitement around stem cells’ therapeutic potential to sell unproven stem cell products to the general public. In 2019, Health Canada issued a Policy position paper on autologous cell therapy products, classifying stem cell-based therapies as drugs under the Food and Drug Regulations. However, five years later, there still remain several predatory autologous stem cell businesses offering services in Canada. The health of Canadians is put at risk with unproven therapies that can create extremely serious adverse effects for patients. A thorough review of the autologous stem cell businesses currently in activity in Canada can provide patient advocates, health professionals, scientists, and policymakers at the federal and provincial level the evidence needed for coordinated action. This communication will present the results of a comprehensive study where we assessed the effects of Health Canada’s 2019 legal revision by examining potential changes for 30 Canadian businesses identified by Turner (2018) and by identifying new businesses operating similarly. Our findings indicate that legal enforcement has been insufficient to curb businesses’ marketing of unproven stem cell therapies and reveal an alarmingly vast marketplace for platelet-rich plasma, another type of unproven regenerative medicine-based therapy, in Canada. The findings of this study are crucial to identifying proactive measures to ensure that the law and its enforcement respond more effectively to the existing threat level represented by faulty regenerative medicine-based therapies.