Just a few months after Health Canada began cracking down on private clinics offering unapproved stem cell therapies, at least one U.S. clinic has moved in to fill the vacuum with direct marketing to Canadian consumers.
The clinic from Burlington, Vermont, even offers shuttle buses to transport people from Ottawa to the clinic four hours away for treatment it suggests will end joint pain, among other things. Lunch and dinner are free, but each injection costs $6,880. Two for $10,880.
The treatments, using umbilical cord-derived mesenchymal stem cells, are not approved in either Canada or the United States. Health Canada warns that Canadians who travel abroad for stem cell treatments “may put themselves at risk.”
While stem cells, which were discovered at the University of Toronto in 1961 by James Till and Ernest McCulloch, promise to revolutionize many treatments and could offer breakthroughs for diseases, almost all are still considered experimental and have yet to be proven safe or effective. Clinical trials on numerous potential stem cell therapies are under way, including in Ottawa.
While research progresses, private stem cell clinics have popped up around the world making promises for treatments not yet proven safe or effective.
A 2018 study by Leigh Turner of the University of Minnesota Center for Bioethics found 43 clinics offering stem cell treatments in Canada and 750 in the U.S. Earlier this year, Health Canada sent Canadian clinics, including some in Ottawa, cease-and-desist letters.
Clinics in Vermont, near the Canadian border, appear to have ramped up marketing to Canadians since then. One clinic has been holding back-to-back seminars. Another says it stopped marketing in Canada after receiving a warning from Health Canada.
There have been cases of harm as a result of treatments, including two women who had permanent damage to their sight after stem cells were injected into their eyes at a Florida clinic. Other patients have been infected with unsterilized equipment and others have developed tumours at the site of stem cell injections.
A common harm, critics say, is exploitation.
Health officials say the clinics are misusing the promise of stem cell therapy to exploit vulnerable patients.
“These patients are in pain and they are suffering and they are looking for help and they are being exploited,” said Dr. Michael Rudnicki, director of the regenerative medicine program and Sprott Centre for Stem Cell Research at the Ottawa Hospital Research Institute.
“If it sounds too good to be true, it probably is too good to be true.”
At a recent seminar at a west-end Ottawa hotel meeting room, Roseanna Ammendolea of the Vermont Center for Regenerative Medicine told a packed room that her clinic and others like it had successfully treated people for pain related to arthritis, neuropathy and other ailments that affected joints using mesenchymal stem cells from umbilical cords. The stem cells, she claimed, are both effective and safe, saying there had been no issues with cell rejection.
“We will not give injections if we feel that this injection will not be beneficial to our patients. This is why we are so successful.”
Participants, including some who walked with canes and others who talked about being in pain and having mobility issues, were shown videos of people described as Canadian clients who claimed the treatments worked. One man said it was “probably the best money I have spent in my life as far as my health.” Another said she would do it again “in a heartbeat” and was able to do things she hadn’t been able to do earlier.
They were also shown a slide showing long wait times for hip and knee replacements in Ontario, “We are not a priority,” she said. “Where does that leave us?” Participants weren’t told exactly how the stem cells were supposed to work, but claimed they had successfully improved pain and mobility issues in clients.
What the seminar goers weren’t told is that, even in the U.S., the treatment is not covered by health insurance because it remains unproven.
The U.S. Federal Drug Administration has issued a warning to consumers not to use cell therapies that are unapproved or unproven.
“Stem cells have been called everything from cure-alls to miracle treatments. But don’t believe the hype. Some unscrupulous providers offer stem cell products that are both unapproved and unproven. So beware of potentially dangerous procedures — and confirm what’s really being offered before you consider any treatment,” the FDA said in a statement.
The only stem-cell-based products that are FDA-approved for use in the United States are blood-forming stem cells derived from cord blood for limited use in patients with disorders affecting the body system that is involved in the production of blood. Bone marrow is also used for these treatments, but is generally not regulated by the FDA for that use.
Health Canada has granted market authorization for a stem cell therapy to treat graft-versus-host disease and two cell-based gene therapies to treat certain cancers. Most cell therapies are still experimental.
“I totally understand the skepticism of it,” Doug Argento, who works at the Vermont Center for Regenerative Medicine, said in a telephone interview, “but the fact is that things that are approved now and medically paid for were seen as renegade 20 or 30 years ago.”
The treatment employs technology developed by Neil Riordan, founder, chairman and chief science officer of the Stem Cell Institute in Panama, using human umbilical cord tissue-derived mesenchymal stem cells. There are 41 such clinics across the U.S. Riordan also played a role in the development of a nutritional product called Stem-Kine, which producers claim — without scientific backing — increases the number of stem cells circulating in a person’s body.
The stem cells injected in the clinic, Argento said, are from umbilical cord tissue as a result of caesarean births to reduce risk of infection.
Rudnicki, of The Ottawa Hospital Research Institute, says there is “no evidence that these sorts of cells are regenerative at all. It would not pass muster in Canada.
“The public has to understand that there are people out to remove them from their money.”
Rudnicki says he regularly receives inquiries from people desperate to get stem cell treatments. He says he tries to connect them with clinical trials that they might be able to participate in.
Rudnicki noted there were multiple clinical trials in Canada, including treatments of autoimmune diseases, trials involving treatment for Type 1 diabetes and others.
“But the use of these inappropriate cell types for treating arthritis and joints and so on is certainly not approved by Health Canada and would not be allowed in Canada under the regulations.”
There is some evidence that injections of some stem cell products might have a temporary positive impact on inflammation, he said, but it will not be regenerative and will not restore function to joints. “They are being sold a bill of goods.”
Leigh Turner of the University of Minnesota Center for Bioethics, meanwhile, says the explosion in clinics offering unproven stem cell therapies in the U.S. is “a marketplace that traffics in misrepresentation. It is easy to see how people are taken advantage of and scammed.”
It is also difficult to find out about physical harms being done to patients.
“There are no safety studies. We don’t have good data. But we do know there have been some serious harms.”
Stem cell therapies have the potential to become standard treatment in some areas, but they are not there yet, Turner said.
“Businesses are tapping into genuine human suffering, desperation and also hope. “
Turner also noted there was an “excellent chance” that the vials of liquid being injected into patients did not actually contain stem cells.
Dr. Jonathan Fenton of another stem cell clinic in Burlington, the Vermont Regenerative Medicine, said he had complained about the new clinic, the Vermont Center for Regenerative Medicine, which has a similar name and employs hard-sell tactics, he said.
His clinic takes bone marrow from patients’ hips and injects it. The procedure is done the same day. He says he regularly sees Canadian patients for bone marrow aspiration therapy and platelet-rich plasma treatments, using their own blood. The treatments, he says, speed healing and are allowed in the U.S. The use of bone marrow aspiration is neither proven nor allowed in Canada.
Fenton, who is secretary-treasurer of the American Academy of Orthopedic Medicine, acknowledged many people offering stem cell treatments are “not doing it to the highest ethical standards.”
He has filed complaints with state officials over clinics selling unsafe or fraudulent treatments. “I have asked the state and federal judiciary to close down this clinic for committing fraud.”
He said his platelet and bone marrow treatments were covered by a major Vermont health insurer because they saw the cost of benefits were going down and patients were requiring fewer surgeries.
He said he was told by Health Canada that he could not market in Canada. Representatives of the Vermont Center for Regenerative Medicine, meanwhile, said they had discussions with Health Canada about what they could and could not say when marketing in Canada before holding seminars in Ottawa and Halifax.
“We have looked at the information provided and have not identified any immediate non-compliance with advertising regulations pertaining to Canadian health products,” a Health Canada spokesperson said, adding that the agency was continuing to assess.
Back at a west-end Ottawa hotel, some participants in the seminar, including a retired pharmacist, said they were considering getting the treatments. “But it’s expensive.”
Another participant said he was skeptical. “They seemed very sketchy when I went online.”