October 29, 2020

The Niche

Knoepfler lab stem cell blog

Regulators in Canada order dozens of stem cell clinics to stop

Health Canada stem cellsNorth America is seeing a major bump in actions by regulators against unproven stem cell clinics with a big step up in Canada. The action has sparked quite a bit of discussion and debate.

Dozens of Canadian clinics were just told by Health Canada to stop selling unproven stem cells. Some of these clinics sold both stem cells and platelet rich plasma (PRP).

Experts up in Canada praised the move even if it seems they had hoped something like this would have come much earlier. For instance, we see this quote:

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.”

Also, Tim Caulfield added this:

“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.”

and this:

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

The clinic operators were, of course, not on the same page as Rudnicki and Caulfield.

In another news piece on this development, a specific clinic seemed in my view to leave open the question as to whether it would comply with Health Canada. Dr. Scott Barr of the Ontario Stem Cell Treatment Centre clearly wasn’t happy with this turn of events and disagreed with regulators:

“In a statement to CBC, Health Canada said it has “not yet seen enough evidence that the [procedures] are safe and effective.”

Barr disagrees.

He said that after exhausting all options approved by Health Canada to cure his chronic back pain he received a stem cell treatment in California that solved the issue. He also recounted the story of a patient with Parkinson’s disease who went from having difficulty walking to competing against his son in high jump as a result of treatment.”

CBC reported that Health Canada sent 36 letters to clinics and included at least one surprise, “Health Canada sent letters to 36 businesses including the Toronto office of the Cleveland Clinic, a Canadian branch of one of the most famous hospitals in the United States.”

What about the Cleveland Clinic here in the U.S.? Are they doing unproven stem cell stuff too?

The above CBC piece ends this way, which is what had me wondering about Barr’s plans, “When asked if he is concerned about the position of the CPSO Barr says he will continue to do stem cell treatments.”

Here’s a second CBC piece about another clinic that’s unhappy with regulators. Dr. Gregory Murphy of Kingston Orthopaedic Pain Institute (KOPI) also seemed surprised by the action:

“They were in contact with us four or five months’ prior to the cease-and-desist, and we laid out in a two-page letter exactly what we were doing, in exactly which patient populations,” Murphy said.

“We were a little bit shocked that the heavy-handedness came down and said, ‘You can no longer do it.'”

Experts having been calling for action on unproven Canadian stem cell clinics there many years. For instance, see this piece from last year quoting from Leigh Turner asking for more from Health Canada.

Unfortunately, regulators generally are slow to move. Still, overall I view this as a postive, even if overdue trend of increased action by North American regulators including the FDA here in the U.S.

Here’s an interesting piece with some very different opinions on the “crackdown”. It’s notable that regulators clarified that PRP is not involved in the regulatory move.

Keep in mind that Canada is a global leader for legitimate, rigorous basic and clinic stem cell research.

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