A stem cell ‘cautionary tale’ as Health Canada cracks down on private clinics

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For the medical team at the Health Sciences Centre in St. John’s, N.L., it was a shocking discovery — a patient had cells from his nose growing in his spine. It was the result of a stem cell treatment gone terribly wrong. 

“It was really surprising,” said Dr. Nanette Hache, a radiologist and assistant professor at Memorial University. “We offered him radiation in the hopes that it would slow down growth.”

The 38-year-old patient sought medical treatment because he was losing function in his arms. 

The doctors assumed he was experiencing complications from a spinal cord injury almost two decades earlier that resulted in partial paralysis.

This should be a cautionary tale for the manipulation of stem cells– Dr. Nanette Hache, Memorial University 

Instead, they discovered a spinal tumour. A biopsy revealed that nasal cells had somehow ended up in his spinal column and they were growing.

That’s when the doctors learned their patient had travelled to Portugal 11 years ago and paid $ 50,000 for an experimental stem cell treatment. 

“He was desperate. He would have done anything basically to walk again,” said Hache. “These guys were providing him with hope and obviously he was willing to spend the money if there was any chance at all he could walk.”

The Portuguese doctors were doing the controversial procedure based on a theory that glial cells harvested from a patient’s nose could be transplanted into the spinal cord where they might help regenerate neurons and promote healing in spinal injuries. 

When Hache and her colleagues searched the medical literature, they discovered reports of several other patients who also developed spinal cord tumours after receiving the same treatment.

“This should be a cautionary tale for manipulation of stem cells in the body because realistically we don’t know what the long-term adverse effects are,” said Hache. “If you transplant stem cells from one organ type into another these type of risks would be a reasonable thing to expect.”

This magnetic resonance image shows a spinal tumour caused by olfactory mucosal cells transplanted from the patient’s nasal cavity in a controversial stem cell procedure performed in Portugal more than a decade ago. (CMAJ)

Hache did not reveal her patient’s name, but said he agreed to have his story published to warn others about the risks of stem cell therapies.

“He’s doing okay. He’s obviously very disappointed with the outcome and everything that occurred,” said Hache. “He wanted people to be aware of this complication because he really didn’t want this to happen to anyone else

Although the Portuguese researchers patented their procedure and published their early results, there has been no long term follow-up for the estimated 140 people around the world who received the treatment, Hache said. Through her research she learned that Portugal group is no longer doing the operations. The lead researcher died in 2012.

‘Not enough evidence’ for effectiveness: Health Canada

The “cautionary tale” was published this week in the midst of a mounting stem cell controversy in Canada now that Health Canada has started cracking down on private clinics offering so-called “stem cell” therapies. 

The agency has sent letters to 36 clinics across the country requesting them to stop doing the procedures until they have received regulatory approval.

None of the Canadian clinics are known to be harvesting nasal cells and performing the type of surgical implants that the Newfoundland patient received in Portugal. Most use cellular fluid extracted from a patient’s bone marrow or fat tissue. That fluid is put into a centrifuge and then some of it is either injected back into the patient’s body, infused intravenously or inhaled through a respirator. 

The clinics do not examine the fluid to determine what kinds of cells it contains, but they assume that there are at least some mesenchymal stromal cells (MSC) sometimes called “adult stem cells” although some experts dispute the validity of that term. 

In May, Health Canada announced that it considers the cell therapies to be a form of drug treatment, which means they must undergo a rigorous review and be formally approved before they can be legally offered to the public.

It’s Health Canada’s first action aimed at reigning in Canada’s thriving cell therapy industry, which has flourished for several years despite warnings from researchers that the safety and effectiveness of the treatments has not been proven. 

My position is I’m a surgeon and I’m doing surgery.– Dr. Scott Barr, Ontario Stem Cell Treatment Centre

Legitimate clinical trials are underway testing the use of cells extracted from adipose or bone marrow tissue for a variety of conditions. But those studies are tightly controlled and patients volunteer to be tested free of charge. Clinics selling direct-to-consumer cell therapies are operating outside of the clinical trial system and Health Canada has ruled that neither the safety nor the efficacy of the procedures has been proven. 

“Generally, products using stem cells to cure or treat disease remain at the investigational stage of development. This means that Health Canada has not yet seen enough evidence that they are safe and effective,” a Health Canada spokesperson told CBC News in an email.

Sudbury clinic continues to do cell procedures

Dr. Scott Barr, a plastic surgeon at the Ontario Stem Cell Treatment Centre in Sudbury received what he described as Health Canada’s “cease and desist” letter on May 23. But he said he is not stopping the treatments. 

“My position is that I’m a surgeon and I’m doing surgery,” said Barr. “They’re saying we’re manufacturing a drug and we’re not. We’re basically allowing patients to use their own cells.”

“I sent a note to Health Canada inviting them to my office to review what we’re doing.”

In fact, Barr said he performed one of the cell procedures on Thursday, treating a patient with Parkinson’s disease by extracting material from the patient’s fat tissue and infusing it intravenously into the patient’s blood. 

Barr said he also administers the tissue extract using respirators and direct injections to treat a range of conditions.

“We do all sorts of stem cell procedures. We do joint injections —hip joints, knee joints, shoulder joints — for arthritic changes. We do other patients with neurologic conditions some people with respiratory conditions so there’s lots of conditions that we’re doing.”

The patients pay thousands of dollars for the treatments.

“It could be anywhere from $ 6,500 and sometimes a little bit more,” said Barr. 

Dr. Scott Barr, a plastic surgeon at the Ontario Stem Cell Treatment Centre, said he will continue to do the cellular treatments despite Health Canada’s order. (Marcus Schwabe/CBC)

A Health Canada spokesperson told CBC News in an email that it intends to verify that the clinics have complied with federal requirements, adding that Health Canada “will take action to address any non-compliance and engage the appropriate provincial or territorial regulatory body as needed, including Professional Colleges within Canada.”

The College of Physicians and Surgeons of Ontario (CPSO) has the power to take disciplinary action against doctors who do not follow Health Canada directives, although a spokesperson said the CPSO could not comment on a specific case.

At the Toronto PRP and Stem Cell Clinic, Dr. Adrian Le is complying with Health Canada’s request to stop the treatments. 

“We sent an email back confirming we would comply with the order,” said Le who has been performing the cell procedures using fat tissue to treat osteoarthritis in the knee and hip. Le estimates he has done almost 100 treatments charging around $ 4,000 for the full therapy. 

He said he has mixed feelings about Health Canada’s actions. 

“On the one hand I understood where they were coming from,” said Le. “There were some clinics both in the United States and in Canada that were doing things outside the bounds of what the research or evidence would suggest stem cells are appropriate for. And I think regulation was needed.”

This an excerpt from one of the letters Health Canada sent to 36 private clinics across the country ordering them to stop advertising and selling cellular therapies. (CBC News)

Back in St. John’s, Dr. Nanette Hache said she has reservations about the safety of the cellular procedures, based on her patient’s experience.

“People are desperate and they will try anything and they will spend any amount of money if they think it can make them better,” said Hache. “With regards to these clinics we don’t know what the long term outcome will be for these patients either.”

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