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Stem Cell Clinics in B.C. and Elsewhere Need More Oversight by Health Canada, Researcher Says

By October 11, 2018No Comments

Stem-cell clinics across Canada, including eight in B.C., are marketing “unproven treatments” directly to health consumers and charging thousands of dollars, a study concludes.

Many of the approximately four dozen clinics are making claims of exaggerated benefits and minimizing potential complications, says the study by Leigh Turner, an associate professor at the University of Minnesota. His study is published in a journal called Regenerative Medicine.

Stem cell-based medicine is an emerging field. For the kinds of therapies offered for myriad conditions by the private clinics, there is no conclusive data on safety and effectiveness to support the claims of potential benefits, the study says.

Patients generally pay thousands of dollars for therapy in the clinics that Turner studied. Most clinics get the stem cells from patients by harvesting their fat in a procedure called liposuction. The extracted fat is then processed to isolate the stem cells, which are injected into the ailing body part where healing is intended to occur.

Dr. Martin Braun, a former emergency room doctor and owner of Vancouver Stem Cell Treatment Centre, could not be reached, but a statement on his clinic’s website said that about 300 procedures have been done there and “no infections or significant complications” have occurred.

The unsigned statement says “stem cells work” but concedes that treatments aren’t perfect and more research is required.

“We welcome greater oversight of this industry as we would like to sort out the clinics which provide legitimate benefit in an ethical and responsible manner from those that do not,” the statement says.

Stem cells give rise to various types of cells —  such as bone, fat, muscle, cartilage and blood cells — which is why injecting them into injured areas of the body may, in theory, be replenishing. But as Turner points out, there is still insufficient high-quality evidence to show that using stem cells harvested from patients’ own bodies is both beneficial and safe in inflammatory and degenerative conditions.

It’s unlikely that clinics have perfected the methods to achieve success, experts say.

The Turner study, called Direct-to-Consumer Marketing of Stem Cell Interventions by Canadian Businesses excluded stem cell products for which there is evidence of benefit such as those that have been provisionally licensed for sale for Health Canada. It also excluded medical facilities doing stem-cell transplants for diseases such as leukemia.

Health Canada has repeatedly come under fire for taking a hands-off approach to these clinics but it said it is monitoring them. The College of Physicians and Surgeons of B.C. said it has not received any complaints about the clinics. And Turner said he has not heard of any disciplinary actions against doctors in Canada who participate in the marketing, sale and provision of stem-cell treatments.

“Patients in B.C. have an explicit legal right to make decisions about their health care including choosing complementary or alternative therapies instead of, or as an adjunct to, conventional medicine,” the College said in a statement.
“Physicians in B.C. may provide unproven therapies as long as they pose no more risk than conventional care and the patient is fully informed. If a patient files a complaint with the College alleging harm, it would be investigated.”
The most common conditions for which clinics are marketing stem-cell injections are orthopedic (osteoarthritis, fracture healing, ligament and tendon injuries), musculoskeletal pain, sports injuries (tendinitis), anti-aging (wrinkles) and disorders like ALS, Parkinson’s, heart disease, lung diseases strokes, multiple sclerosis, scleroderma, muscular dystrophy, and erectile dysfunction.
Turner said he is skeptical of the claims made by companies on their websites and in their advertising. “In general, they exaggerate the likelihood of therapeutic benefits and minimize the possibility of complications,” Turner said.

“Patients who have unproven and unlicensed stem cell interventions are at risk of suffering complications related to the cells administered to them. The degree of risk depends on such factors as the source of the cells, the type of cells injected or infused into patients, how cells and tissues are processed while they are outside the body, where the cells migrate after they are administered, and whether the wrong kind of cells aggregate in the wrong location.

“Complications, depending upon a variety of factors, could include stroke, pulmonary embolism, painful cellular masses, infections, blindness, or other complications,” Turner said.

“Financial harms are also worth noting given that patients typically pay thousands or tens of thousands of dollars for unproven stem cell interventions. Obviously, I’m not trying to claim that all patients who undergo unproven stem cell interventions must inevitably suffer horrible injuries. Rather, I’m drawing attention to cases where such harms have occurred,” he said.