In cases where autologous cell therapies are being used without the proper indications or scientific research, Health Canada is taking the right approach. But it needs to be careful and nuanced.
Health Canada announced recently that it was engaged in a more aggressive crackdown on clinics offering autologous cell therapies, citing the lack of evidence for these procedures and the potential for harm from unsafe techniques in their administration. This comes on the heels of its position paper, published as the first shot across the bow.
Autologous cell therapies are defined as therapeutic products produced for individuals using their own biological starting material. Generally speaking, this refers to the process whereby a patient’s blood is obtained, subsequently processed, then returned to the patient usually through intravenous or injectable procedures. The most popularized of these methods is the use of stem-cells.
The majority of Health Canada’s efforts have been focused on clinics offering stem-cell procedures as treatments for pain, anti-aging cosmetics and conditions such as multiple sclerosis (MS) and autism. The lack of comprehensive evidence for these costly therapies is an example of what experts call “scienceploitation,” and puts patients at an increased likelihood for developing complications, a situation that could be viewed as all risk with no reward.
In cases where autologous cell therapies are being used without the proper indications or scientific research, Health Canada is taking the right approach in its posture for sanctions. However, given the diversity that exists within the definition of autologous cell therapies, Health Canada should be more nuanced with the language it uses with respect to its policies.
For example, platelet-rich plasma (PRP) – a technique that creates a high-concentration platelet mixture from centrifuged patient blood – is also considered an autologous cell therapy. However, unlike the lack of evidence for stem-cell therapies for certain conditions, PRP has been shown to be effective in a number of specific musculoskeletal pathologies.
According to MSK Medicine, a physician-led translational knowledge resource for evidence-based musculoskeletal clinical care, PRP has been shown to be useful in function and pain reduction for tennis elbow and knee osteoarthrits.
These procedures were also evaluated for their safety and were shown to have similar adverse events compared to a control group not using the procedures. It should be noted that PRP for other types of conditions like ankle arthritis are not proven to work.
Health Canada invokes the Food and Drugs Act in order to make the distinction that any blood product removed from and reintroduced to a patient is a drug and therefore subject to regulation. This important interpretation is well-meaning and is aimed at ensuring that the Canadian public health interest is maintained as its top priority. As Canadians, we should value the efforts of the agency in attempting to safeguard the health of our communities.
The importance of language should be a focus given our current context of pseudoscience proliferation. With the rise of anti-vaccination rhetoric and correlated increases in diseases like measles, Health Canada has an extremely important role in our society. It should, therefore, seek to enact regulations that will encourage a collaborative approach to medical innovation without compromising both patient safety and progress.
Ultimately, given that medical science is careful and nuanced, we should expect the very same from the organization that is responsible for important patient care regulations.
Dr. Adam Kassam is a rehabilitation physician based in Toronto. Dr. Kshitij Chawla and Dr. Najam Mian are clinical assistant professors at the University of British Columbia and co-founders of the Canadian Pain & Regenerative Institute.