Health Canada says approval is required before stem cell therapies can be legally offered to patients but private clinics are performing unproven stem cell procedures on patients across Canada without approval.
Health Canada stated, “All cell therapies are considered drugs.This means that the distribution and use of these products would require authorization by Health Canada.”
Yet none of the stem cell injections being offered by private clinics have been approved by Health Canada.
Stem cells are a unique category of human cells that can develop into a variety of specialized cells. Scientists are studying the possibility of using stem cells to regenerate organs and tissues, and to treat human diseases.
But it’s still at the experimental stage. No stem cell therapies have been approved for human use, except the long established use of bone marrow transplants to treat blood disorders and cancer. There is also a stem cell product approved to treat complications from a childhood cancer treatment.
It has been identified that almost two dozen private clinics in Quebec, Ontario, Alberta and British Columbia that are advertising stem cell injections directly to patients through internet sites.
The procedures only take an hour or so and are done in doctors’ offices. The doctor extracts bone marrow or fat tissue from the patient, spins it in a centrifuge machine while the patient waits, and then injects the material into the patient’s knee or hip or other parts of the body.
The procedures are advertised to treat osteoarthritis and a variety of muscle, joint and sports injuries.
Stem cell injections seem to be falling between regulatory cracks. Health Canada is struggling with how to regulate this burgeoning practice. And none of the provincial colleges of physicians and surgeons, which regulate doctors, has a policy about them.
“Health Canada approval is required before any cell therapy can be legally used on human patients,” a Health Canada spokesperson said in an email.
But so far, the federal ministry has not taken any action to halt the growing stem cell industry.
In the U.S., where doctors are doing a broader range of unproven approaches, three women went blind from stem cell injections into their eyes to treat macular degeneration.
Health Canada says, “Health Canada is currently assessing the information to determine whether the specific activities being conducted by the clinics are subject to the Food and Drug Regulations and whether these clinics are in compliance with federal regulatory requirements.”