Debate over Health Canada crackdown on stem cell therapies

CTV National News: Stem cell therapy controversy Health Canada has ordered dozens of clinics to stop offering stem cell therapy. Avis Favaro with reaction to the decision.

Once seen almost exclusively as a treatment for certain cancers, an increasing amount of health care providers are offering stem cell therapies to treat conditions like autism, multiple sclerosis (MS), and ALS -- a practice Health Canada warns has “not been proven to be safe or effective.”

Now the government agency has begun cracking down on clinics offering treatments that inject patients with their own stem cells, unless it’s for research purposes, issuing warnings to some three dozen health care providers in four provinces, including B.C., Alberta, Ontario, and Quebec.

“The marketing of unproven stem cell therapies has been a problem for a very long time and it’s becoming a bigger problem here in Canada,” Professor Timothy Caulfield, research director at the University of Alberta’s Health Law Institute, told CTV News.

“I think it’s really important to emphasis, despite all of the excitement around stem cells, there are very few therapies that have good clinical evidence to support their use.”

To date, Health Canada has granted market authorization only for one stem cell therapy to treat Graft versus Host Disease (GvHD), and two cell-based gene therapies to treat certain cancers.

Toronto –based sports medicine clinic Toronto PRP and Stem Cell was one of the clinics to receive a warning from Health Canada with instructions to cease the sale and advertisement of stem cell therapies.

The clinic’s medical director, Dr. Adrian Le, is a sports medicine specialist who has been using stem cells taken from a patient’s fat and injecting them into their knees and hips to treat painful osteoarthritis.

“After six months out they feel a range of motion, less pain, less swelling, more flexibility and the ability to do more functional abilities that they want to do,” said Le.

Though he acknowledges that the use of stem cells to treat osteoarthritis is still in the early stages of research, he said for patients willing to pay for the therapy, it may provide relief from pain and delay the need for a joint replacement.

“I understand where HC was coming from and I do believe there is a need for regulation in the stem cell and ortho-biologic fields and therapies. My worry, is that enforcing the policy the way we did it, patients ended up losing access to legitimate treatments  that could benefit them," said Dr. Le.

Le is now fielding calls from patients like “John,” who asked CTV News not to use his real name.

At 53 years old, John had severe hip pain but didn’t want a joint replacement. After receiving the stem cell treatment three months ago his pain improved significantly, but he now wants his right side treated.

"I got my left hip treated and I can honestly say it is about 90 per cent better,” John told CTV News. “The pain disappeared."

Studies around the world are trying to assess the potential of stem cells to heal injuries or treat diseases. But some practitioners are offering stem cell treatment for advanced MS, ALS, autism, or cerebral palsy, for which there is no clear science to validate the use of stem cells.

Caulfield notes that these treatments provide a risk for financial exploitation, with treatments costing thousands of dollars.

“People are spending thousands of dollars, on a therapy that perhaps doesn’t have a lot of good evidence to back it up,” he explained.

“There have been harms associated with this industry, so this is serious business and we do need, at a minimum, some kind of broad regulatory response.”

Peggy Dunbar, who suffered from advanced ALS, spent $10,000 for stem cell therapy at a Toronto clinic. The treatment didn’t work.

Dunbar has since passed away, but her husband agrees with Health Canada’s efforts to crack down on clinics promoting stem cell therapies without thorough scientific evidence.

“Absolutely they should be regulated,” Dunbar’s husband, Harry, told CTV News. “They market their product based on the needs of desperate people.”

In the letters to the clinics, Health Canada ordered the crackdown because it considers stem cell therapies “drugs” and any health care provider must obtain market authorization from the health agency to sell a drug—a claim many clinicians refute.

“Health Canada has arbitrarily decided that the separation of adult mesenchymal stem cells from a patient’s own tissue is tantamount to ‘manufacturing’ a drug, despite the fact that the stem cells are not altered or modified in any way,” Dr. Scott Barr, director of the Sudbury-based Ontario Stem Cell Treatment Centre, told CTV News in an email.

“Only the patient ‘manufactures’ their own cells.  We are simply harvesting, washing and concentrating the cells, then placing them back into the patient to do the work that they are meant to do.”

Dr. Le, whose clinic has stopped offering stem cell therapies, said that although he believes there is a need for greater regulation in the stem cell field, he worries that enforcing strict policies may prevent patients from getting safe access to treatment.

“My hope is that we are going to find a way from Health Canada to move forward to ensure patients are protected from opportunists in this field, but at the same time have access to these cutting edge treatments from properly trained physicians without having to travel to the United States or elsewhere,” he said.

“The reality is that patients who really want this done will find a way to get it done and to me it is favourable to have it done in Canada by physicians who know what they are doing.”

Some of the Health Canada correspondence included references to another procedure called Protein-Rich Plasma (PRP) transfers, which is widely used in sports medicine.

Blood is taken from a patient and the plasma, containing growth factors, is removed and injected into injured joints. It’s often offered in its own or in conjunction with stem cell treatments. Tiger Woods and other noted athletes have had this procedure.

In an email to CTV News, Health Canada indicated the crackdown did not involve PRP - writing: "The administration of PRP may be considered to be an established medical practice by provincial health care professional colleges in instances where autologous PRP is obtained by the centrifugation of whole blood which is then injected immediately into patients by licenced health care practitioners operating under their scope of practice. In these instances, the provincial colleges could provide oversight of this practice."