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 鈥渘ot been proven to be safe or effective.鈥�
Now the government agency has begun cracking down on clinics offering treatments that inject patients with their own stem cells, unless it鈥檚 for research purposes, issuing warnings to some three dozen health care providers in four provinces, including B.C., Alberta, Ontario, and Quebec.
鈥淭he marketing of unproven stem cell therapies has been a problem for a very long time and it鈥檚 becoming a bigger problem here in Canada,鈥� Professor Timothy Caulfield, research director at the University of Alberta鈥檚 Health Law Institute, told 麻豆影视.
鈥淚 think it鈥檚 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.鈥�
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 鈥揵ased 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鈥檚 medical director, Dr. Adrian Le, is a sports medicine specialist who has been using stem cells taken from a patient鈥檚 fat and injecting them into their knees and hips to treat painful osteoarthritis.
鈥淎fter 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,鈥� 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.
鈥淚 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 鈥淛ohn,鈥� who asked 麻豆影视 not to use his real name.
At 53 years old, John had severe hip pain but didn鈥檛 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,鈥� John told 麻豆影视. 鈥淭he 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.
鈥淧eople are spending thousands of dollars, on a therapy that perhaps doesn鈥檛 have a lot of good evidence to back it up,鈥� he explained.
鈥淭here 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.鈥�
Peggy Dunbar, who suffered from advanced ALS, spent $10,000 for stem cell therapy at a Toronto clinic. The treatment didn鈥檛 work.
Dunbar has since passed away, but her husband agrees with Health Canada鈥檚 efforts to crack down on clinics promoting stem cell therapies without thorough scientific evidence.
鈥淎bsolutely they should be regulated,鈥� Dunbar鈥檚 husband, Harry, told 麻豆影视. 鈥淭hey market their product based on the needs of desperate people.鈥�
In the letters to the clinics, Health Canada ordered the crackdown because it considers stem cell therapies 鈥渄rugs鈥� and any health care provider must obtain market authorization from the health agency to sell a drug鈥攁 claim many clinicians refute.
鈥淗ealth Canada has arbitrarily decided that the separation of adult mesenchymal stem cells from a patient鈥檚 own tissue is tantamount to 鈥榤anufacturing鈥� a drug, despite the fact that the stem cells are not altered or modified in any way,鈥� Dr. Scott Barr, director of the Sudbury-based Ontario Stem Cell Treatment Centre, told 麻豆影视 in an email.
鈥淥nly the patient 鈥榤anufactures鈥� 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.鈥�
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.
鈥淢y 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,鈥� he said.
鈥淭he 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.鈥�
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鈥檚 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 麻豆影视, 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."
