The field of stem cell research has received a great deal of attention as it offers great promise for the treatment of numerous diseases through cell therapy and regenerative medicine. Despite this potential, it is believed that further research is required before this technology can be utilized in a safe and routine manner in patients.
In response to reports of a rise in the number of private Canadian clinics selling unapproved stem cell treatments for arthritis and other orthopedic conditions, Health Canada has indicated that it is following up with select clinics to verify compliance with the Food and Drugs Act.
To date, only one stem cell therapy has been approved in Canada. Both in Canada and in many other countries, there are however private clinics that offer and advertise various unapproved stem cell treatments and do so by circumventing restrictions and guidelines set up by public national health departments such as Health Canada and the US FDA.
"The key word here is minimal manipulation," stated Jas Chahal (University of Toronto, Canada). "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."
The governmental department also stated 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.”
This news follows a recent declaration of intent from the US FDA, with regard to the organizations plans to increase oversight and enforcement over stem cell therapies and regenerative medicine. This came in the form of a statement issued by Scott Gottlieb, commissioner of FDA, which has been supported by various experts including past President of the ISCT, Massimo Dominici.
In line with this, the FDA also recently announced that it has issued a warning letter to a US stem cell clinic for marketing unapproved stem cell products and significantly deviating from current good manufacturing practice guidelines.