OTTAWA – Health Canada is advising Canadians that some clinics and health care practitioners are offering unauthorized cell therapies, such as stem cell therapy, suggesting that these treatments are safe, and are making unproven health claims to patients. These actions may pose risks to Canadians. Unauthorized treatments have not been proven to be safe or effective and may cause life threatening or life altering risks, such as serious infections. That is why Health Canada published a position paper to clarify the regulatory status of these products.
All cell therapies are considered drugs under the Food and Drugs Act. This means that they must be authorized by Health Canada to ensure that they are safe and effective before they can be offered to Canadians.
To date, Health Canada has granted market authorization only for the stem cell therapy Prochymal to treat Graft versus Host Disease (GvHD), as well as two cell-based gene therapies, Kymriah and Yescarta, to treat certain cancers. However, most cell therapies are still experimental. This means that they may be administered to Canadians only if the health care practitioner is conducting a clinical trial authorized by Health Canada.
One current trend in cell therapies is for-profit clinics offering a process called “autologous cell therapies,” which may also be offered to patients under other names, such as “bone marrow aspirate concentration (BMAC) injections,” “stromal vascular fraction (SVF),” or “adipose-derived stem cells.” This process uses people’s own cells to treat their health conditions. These therapies involve removing some cells from the patient, manipulating or processing those cells, and then reintroducing them back into the patient. The intent is to treat or prevent a disease, disorder or medical condition, such as pain or osteoarthritis. Because autologous cell therapy uses a patient’s own cells, practitioners may suggest that these treatments are safe; however, they have not been proven to be safe or effective.
The Department has taken action against multiple clinics that offer cell therapies. If any clinic is found to be offering unauthorized cell therapies to Canadians, Health Canada will follow up and take appropriate and timely action.
To verify that treatments are authorized, Canadians should refer to Health Canada’s Drug Product Database and Clinical Trials Database to confirm authorized cell therapies and cell therapies under clinical trials, respectively.
Health Canada encourages Canadians to report the potential non-compliant sale or advertising of unauthorized cell therapies by submitting a complaint to Health Canada using its online complaint form. Canadians can also report any adverse events from health products, including unauthorized cell therapies, to Health Canada by calling toll-free at 1-866-234-2345, or by reporting online, by mail or by fax.