It has been widely reported recently, that Health Canada has started cracking down on private clinics offering so-called “stem cell” therapies.
The agency sent letters to 36 clinics across the country requesting them to stop performing stem cell treatments until stem cells have received regulatory approval. Health Canada considers all cell therapies to be drugs under the Food and Drugs Act.
The provincial Colleges of Physicians and Surgeons, who regulate physician licenses and practices, have the power to take disciplinary action against doctors who do not follow Health Canada directives.
What are Stem Cells?
Most cells have specific functions in the body. Stem cells are cells that do not yet have a specific role and can become other cells that are required. Adult stem cells can divide or self-renew indefinitely.
Stem cells originate from two main sources: adult body tissues and embryos.
Stem cells are present inside many different types of tissue. They are generally isolated from a patient’s own bone marrow or fat cells; these are referred to as autologous stem cell transfers.
Occasionally, stem cells are taken from a matched related or unrelated donor (allogeneic stem cell transfer). Because stem cells can take on the role of many types of cells, they can be used to regenerate damaged tissue, under the right conditions.
“Stem cell treatments have been used to treat a number of chronic diseases (e.g. Osteoarthritis) affecting hip, knee, shoulder and other joints. In addition, certain neurologic conditions and respiratory conditions have also been treated with stem cells.”
Even though autologous cell therapy uses a patient’s own cells, Health Canada’s opinion is that they have not yet been proven to be safe or effective. Therefore there remains an on-going need to gather supporting scientific evidence.
What are Exosomes?
Exosomes are used to transport information (proteins, growth factors or other messengers) beyond the cell to allow communication with other cells. Exosomes produced by stem cell can exert positive effects on regeneration in many tissues. It is believed that exosomes are the primary mechanism by which stem cells are able to exert a local healing and regenerative effect on other cells. However, exosomes lack the cellular material and potential immune reactions that comes with some stem cell therapies.
The field of exosome research is currently exploding. In the future, more refined exosome therapies will be available, which can target specific diseases. In addition, exosomes are being studied to see if they can be used to transfer tiny drug packages, able to precisely target “bad” cells.
What is Health Canada?
Health Canada is the Federal department responsible for helping Canadians maintain and improve their health, while respecting individual choices and circumstances. It does so by preserving and modernizing Canada’s health care system, enhancing and protecting the health of Canadians, working in partnership with other agencies, and by communicating health promotion and disease prevention.
Canadian Regulatory Context:
Health Canada’s authority to regulate health products comes from the Food and Drugs Act that was enacted by Parliament to protect Canadians from unsafe and deceptive practices relating to therapeutic products. Cell therapy products collected and manipulated for use in the diagnosis and treatment of disease or in restoring organic functions, meet the definition of drug in the Act.
International Regulatory Context:
Other national regulatory authorities, such as the US Food and Drug Administration (US FDA) and the European Medicines Agency (EMA) have laws similar to Canada’s that allow them to regulate the distribution of cell therapy products in their respective jurisdictions. However, important differences exist. In particular, the European Union (EU) has enacted regulations specifically for cell therapy products, while the US FDA, like Health Canada, applies existing drug regulatory frameworks. Some national regulatory authorities have special exemptions for certain cell therapy products, which explains why stem cell therapies in other jurisdictions are easier to acquire than in Canada.
What is Health Canada’s Position Regarding Stem Cells?
In May, Health Canada announced that it considers the cell therapies to be a form of drug treatment, which means they must undergo a rigorous review and be formally approved before they can be legally offered to the public. Health Canada considers that products using stem cells to cure or treat disease remain in the investigational stage of development. This means that Health Canada has not yet seen enough evidence to state that they are safe and effective,
Health Canada’s position statement regarding stem cells can be read at the following link:
What is PRP?
Plasma is the liquid portion of whole blood. It is composed largely of water and proteins, and it provides a medium for red blood cells (RBCs), white blood cells (WBCs) and platelets to circulate through the body. Platelets, also called thrombocytes, are blood cells that cause blood clots and other necessary healing functions.
“PRP is the common term used to describe Platelet-Rich Plasma. To make PRP, blood is taken from a patient, centrifuged and the PRP is removed from the plasma and RBCs. It is then injected into injured joints, skin, the scalp or elsewhere. Platelet activation plays a key role in the body’s natural healing process.”
Activation occurs to release growth factors from the platelets. These growth factors then attract and direct healing cells to the area, including the patient’s own stem cells. PRP is offered on its own or in conjunction with stem cell treatments and/or with the addition of other growth factors (in the form of exosomes).
What is Health Canada’s Position Regarding PRP?
Some of the Health Canada correspondence included references to another procedure called Platelet-Rich Plasma (PRP), which is widely used in sports medicine.
In an email to CTV News, Health Canada indicated the crackdown did not involve PRP further, the Health Canada representative stated in writing:
“The administration of PRP may be considered to be an established medical practice by provincial health care professional colleges in instances where autologous (from the same patient) PRP is obtained by the centrifugation of whole blood which is then injected immediately into patients by licenced health care practitioners operating under their scope of practice. In these instances, the provincial colleges could provide oversight of this practice.”
Bottom Line: External Affairs has never offered stem cell therapies to our clients. PRP is used for a number of procedures. All the providers that use PRP have been appropriately trained to do so, in compliance with requirements.