The stem cell police are going global evidently. Health Canada even encourages people to fill out a form - "Canadians are encouraged to report information related to potential non-compliant products or activities related to health products using Health Canada's online complaint form."

Health Canada investigates Canadian stem cell clinics
CBC News Posted: Sep 09, 2017

http://www.cbc.ca/news/health/second...0909-1.4281703

Health Canada investigates private clinics selling unapproved stem cell therapies

Last week in Second Opinion, we told you about the rise of private Canadian clinics selling stem cell treatments for arthritis and other orthopedic conditions. This week Health Canada told CBC News it is following up with some of those clinics "to verify compliance with the Food and Drugs Act."

Health Canada has approved only one stem cell therapy in Canada, for use in complications from a childhood cancer treatment. Yet across Canada private clinics are offering a variety of stem cell treatments for arthritis and other orthopedic conditions.

They're unproven and they're expensive. And until recently they were only available through medical tourism. But increasingly, private clinics in Canada are advertising stem cell therapies, especially for osteoarthritis and other orthopedic conditions.

"To date, Health Canada has not taken compliance and enforcement action against any Canadian clinics offering direct to consumer stem cell therapies," Health Canada said in an email.

One expert told CBC News that the private procedures appear to fall outside the jurisdiction of Health Canada. That's because the method used to process the injected material is considered "minimally manipulated."

The two most common procedures use bone marrow aspirate concentrate or adipose derived stem cells which are removed from a patient's bone or fat tissue. The extract is placed in a centrifuge and mixed at high speed and then reinjected into the same patient the same day. The theory is that the extract contains cellular material that will help relieve pain or promote healing.

"The key word here is minimal manipulation," said Dr. Jas Chahal, orthopedic surgeon at Toronto's University Health Network. "If you minimally manipulate and you inject it into a knee or a hip, that's considered minimal manipulations. You don't need formal Health Canada approval for that."

But Chahal adds that the extract is not a pure "stem cell" product but rather a combination of biological material that includes stem cells.

"I think it's important to overcome that perception that you're getting a pure stem cell procedure," Chahal said. At the University Health Network he is conducting one of the few formal trials on the use of stem cells to treat osteoarthritis. In his study, the cells are removed and harvested in a lab, tested for safety and then reinjected into a patient's knee.

"The first thing to realize is that unless you're part of a clinical trial these are not expanded stem cells. So what you're getting is fat tissue that's broken down or you're getting bone marrow that's concentrated."

The procedures have not been tested in rigorous clinical trials to see whether they work. Basic questions have not been answered. Scientists still don't know what happens to the cells after they're injected. And they have not established a biological explanation for how the therapy could improve osteoarthritis or other orthopedic conditions.

"We still have to show that you can regenerate tissue," he said. "I think it's the responsibility of the scientific community to do these trials, and I think over the next four to five years this information will become available."

We asked to speak to someone at Health Canada for clarification about regulations on direct-to-consumer stem cell therapies but were told there was no spokesperson available.

In the meantime, Health Canada said in an email that "Canadians are encouraged to report information related to potential non-compliant products or activities related to health products using Health Canada's online complaint form."