Regulators in Canada order dozens of stem cell clinics to stop

Health Canada stem cells

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.

9 Comments

  1. Opioids. How about regulating those that kill so many of us?
    Would like to know how many people have died as a result of these stem cell treatments. What are the statistics?

  2. In speaking with a gentleman who owns race horses recently, we started speaking about knee surgery on his wife and on my own knees. I just posed the question;, If his wife had considered stem cells for her knees. His reply was, yes, and that he has been having vets inject stem cells into his injured race horses for years, with great success. Before stem cells they had used, steroids, which only lasted a short time, but with the stem cells the horses knees were like new. Now, if stem cells does that much good in animals, would it not do the same for humans? If it was legal to have a vet inject the cells into my knees, I would be there now. Why can’t we have as good as is offered to horses? Why?

    • @Judith,
      Yes, there has been some promising work in veterinary regenerative medicine, although I don’t know that that has been totally proven yet. Unfortunately, what works in animals doesn’t always work in people either. There are also different standards for humans and animals in terms of what’s OK or not.
      My impression is that even in animals, stem cell injections into injured or arthritic joints don’t really make them “like new” and even most stem cell clinics no longer claim that there is new cartilage growth. That idea seems debunked at least until someone finds a new approach that truly grows new cartilage.
      It seems at this point at best stem cell joint injections are just a partial solution that reduces inflammation so in many not so different than a steroid injection, but with higher risks.

      • As a physician who has utilized steroids for pain management for almost 20 years AND as a 50yo male who has had both a partial menisectomy on one knee and BMAc on the other… both within the last year. I’d take the BMAc injection and its outcome over surgery every day of the week. Even if the BMAc was nothing more than a auto-anti-inflammatory injection, the ultimate effect is superior to the FDA approved surgery I had on the other knee. Both meniscal injuries were almost identical.

        On the surgical side, I developed both a medial femoral condylar and separately a tibial plateau stress fracture on the surgical side secondary to meniscal resection and changes in articulation and weight bearing. Both within 3 months of surgery. Also, I now feel a slight instability with planted rotation.

        On the BMAc side, I have had complete resolution of pain and almost complete return of range of motion (small residual effusion which comes and goes depending on activity level). I would give my surgical side a 7/10 on results and the BMAc side a 9/10.

        Concerning safety of steroids… they are safe within our realm of accepted and understood risks. But they are in no way without issues. Cartilaginous degradation, dural thinning, vasogenic atrophy… these are all known, understood, and accepted risks of our current FDA approved regimen. I dare say, if steroids were introduced today, they would not pass FDA muster… but then again… neither would aspirin.

          • Dr. Knoepfler. Without much effort you were able to find two studies in Pub Med involving human patients and their use of Autologous Bone Marrow Concentrate for the treatment of orthopedic problems relative to the knee. (ACL Tears and Osteoarthritis) Now admittedly these two studies do not represent the “Gold Standard” of RCT’s or Randomized Clinical Trials. And, both do call for additional studies in their conclusions. Yet despite your concern in at least one post ( https://ipscell.com/2012/04/the-real-but-oft-ignored-dangers-of-adult-stem-cell-treatments/)
            (that autologous stem cell transplants represent the possibility of tumor formation) these two studies demonstrate otherwise. Not a single word in either of the two abstracts that you found about cancer or tumor formation relative to the patients studied. Furthermore nothing exists in either of these article abstracts about even a potential immune response after injection of autologous BMC. Yet, I think it’s pretty well known that Induced Pluripotency as well as Embryonic Stem Cells both contain tumor formation AND immune rejection properties which have prevented clinical studies; even of the sort that you just found in your pub med search. And there are other studies like these two in Pub Med regarding the use of Autologous bone marrow concentrate AND adipose derived stem cells. But this does not appear to be the case with regard to HESC’s. and even autologous IPSC’s.

            To me there exists in you and others an almost dogmatic philosophy about the need to subject autologous stem cell therapies to these RCT’s (Double Blind, Placebo Controlled, Multi Center, International, Phase I,II,III Clinical Trials) as though that were the only avenue to medical or scientific knowledge. The fact that you discovered these two clinical studies in Pub Med means that they made it to the medical literature. They passed a certain degree of medical and or scientific sophistication. But comparatively speaking, this does not appear to be the case relative to Induced Pluripotency or Embryonic Stem Cells. The studies that you discovered are finished! And they appear at the very least to have a pretty flawless safety profile despite your claim of “higher risks” when compared to FDA approved cortisone injections. (@Judith) To me, Autologous stem cell studies in humans support the work already taking place clinically. They speak for themselves. Human Embryonic and Induced Plutipotent stem cells haven’t, in a manner of speaking, even made it to the starting line.

            • @Douglas,
              Yes, there definitely are more clinical studies using adult cells. They’ve been around a lot longer and generally they have a predicted and in some cases demonstrated better safety profile at this time.

              But there are a number of hESC and IPS cell clinical trials ongoing in the US and Japan. So they have crossed the starting line. More are on the way. We’ll see what the data tell us. So far there have not been tumors in the earliest data so that’s encouraging.

              The adult stem cell clinical studies are numerous, but a mixed bag. There are probably about equal encouraging and discouraging papers. They haven’t proven much so far either if one looks at FDA approvals or equivalents in other countries.
              Adult stem cell studies going the non-FDA route generally haven’t demonstrated safety and efficacy either.
              I don’t believe in charging (whether at a clinic or at a university doing a clinical trial with an FDA cleared IND) for unproven stem cell offerings.
              I’ve called out both clinics and universities that seem to be requiring patients to pay just to be in a study or have their child (e.g. autism) be in a study.

  3. It is important to remember that many of these clinics offering unproven/untested stem cell treatments have a huge bias to report or claim beneficial effects, even where there is not data showing said effects, as they are looking to make a sale. This is true of both vet and human ‘stem cell medicine’. Also, numerous studies have shown that the placebo effect can be real and fairly large, so without trials its impossible to determine if there is an effect if its due to the stem cells or another factor. And of course people selling a product are often loath to report no effects or detrimental effects. If a horse dies as a complication, the stem cell vet company doesn’t often broadcast that at all.

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