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Canada Health Canada orders halt to unproven stem cell-based injection treatments

A growing number of experts have called for regulatory action against clinics offering cell-based therapies in recent years.

MICHAEL DALDER/Reuters

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.

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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.”

Justin Boutilier, chief operations officer of LightTouch Med Spa, which has five locations in the Greater Toronto Area, said they were forced to stop offering PRP treatments after receiving a letter from Health Canada. He said the clinic primarily used the injections for treatment of hair loss and skin tightening. The PRP treatments can be used as a filler to help improve the skin’s appearance, he said. The company felt blindsided by Health Canada’s decision, and he doesn’t understand why their services are being targeted when other cosmetic treatments, such as the use of lasers, are allowed to continue.

“They haven’t provided any examples of how it’s unsafe or why it’s unsafe,” Mr. Boutilier said.

Adrian Le, medical director of Toronto PRP and Stem Cell, said he has stopped offering stem cell treatments after being contacted by Health Canada, but that they have allowed him to continue PRP services for conditions such as osteoarthritis. Dr. Le said he is working on research to study the efficacy of the procedure. He said he understands that Health Canada had to take some form of regulatory action, but wonders about what this will mean for the future of these sorts of treatments.

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It’s unclear how effective Health Canada’s crackdown will be. Mr. Boutilier said he’s spoken to some clinics who plan to continue offering cell therapies until they face some sort of punitive measure, such as a fine. And many clinics are still advertising stem cell and PRP services online.

Mr. Caulfield said despite the claims, there is no high-quality scientific evidence showing PRP, stem cell or other cell-based therapies work. He pointed to the industry as one aspect of a growing trend toward unproven treatments that use the language of science and medicine to sell services to the public.

“We’ve got to be more aggressive pushing back against this,” he said. “Just because it sounds science-ey doesn’t mean it works.”

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