Health Canada in ‘overdue’ crackdown on unproven stem-cell based treatments
2019-07-08 from theglobeandmail.com
Health Canada has launched a crackdown on clinics offering unproven, potentially unsafe treatments that inject a patient with their own cells, ordering three dozen of them to stop offering the services immediately.
The clinics, located in B.C., Alberta, Ontario and Quebec, advertised a variety of stem cell and platelet-rich plasma (PRP) treatments for numerous conditions, including heart problems, arthritis, multiple sclerosis, Crohn’s disease, hair loss and skin rejuvenation. Many clinics claim stem cells can be extracted from individuals and injected back into the individual to promote healing. Platelet-rich plasma treatments involve getting a concentrated amount of platelets from a patient’s blood and injecting it back into the person, which is also supposed to encourage healing.
The crackdown comes after Health Canada published a position paper in May stating that most autologous cell therapies – those that use a patient’s own cells – have little evidence showing they work and can pose risks, such as cross-contamination between patients if equipment isn’t sterilized properly or potentially dangerous immune reactions. In 2017, the New England Journal of Medicine reported examples of cell-based therapies leading to serious harm, including three people who were blinded in 2015 after receiving unproven stem cell injections at a Florida clinic to treat vision problems. According to Health Canada, all cell therapies are considered drugs and anyone that wants to offer cell-based treatments must submit clinical research showing they are safe and effective.
Michael Rudnicki, scientific director of the Stem Cell Network, which provides funding and support to stem cell researchers, said the decision by Health Canada to take action against these clinics is long overdue.
“It’s a step in the right direction, but they really need to step up their enforcement,” he said. "The public really has been misinformed by these clinics and by this advertising."
A growing number of experts have called for regulatory action against clinics offering cell-based therapies in recent years. They say the clinics are peddling misinformation to sell expensive stem cell or PRP treatments that don’t live up to the marketing hype.
“We know that there are an increasing number of clinics across North America that are selling these unproven therapies,” said Tim Caulfield, Canada Research Chair in health law and policy at the University of Alberta. “I think it’s really important to emphasize this stuff is unproven.”