What are the only stem cell therapy conditions currently approved in Canada?

As of 2020, Canada has approved a total of 3 cellular therapeutic products! These include the use of stem cells for the treatment of acute lymphoblastic leukemia (ALL), Adult B-cell Lymphoma, and Graft V Host disease.

Most approved therapies use hematopoietic stem cells (HSC). Bone marrow, blood, and the umbilical cord all contain HSCs. HSCs mature into cells that make up the blood and immune system. This makes them perfect for the treatment of conditions such as leukemia, lymphoma, and blood disorders. We can now treat over 80 medical conditions with the HSCs collected from cord blood.

Three cellular therapeutic products do not sound like enough. To understand why there are a few approved stem cell therapies on the market we must first ask the following questions:

How do stem cell therapies get approved in Canada?

In Canada, all cell therapies are considered drugs under the Food and Drugs Act. They must be authorized by Health Canada to ensure they are safe and effective before they are offered to Canadians. All other treatments are experimental or unproven. Canadians should refer to Health Canada’s Drug Product Database [2]and Clinical Trials Database [3].

How do stem cell therapies work?

Stem cell therapies can work in one of two ways to reduce the severity of a disease or disorder. The first is a stem cell transplant, and the second one is to act as a target for a drug or other biologic. A stem cell transplant is when existing stem cells in your body, which have been damaged or destroyed by disease, are replaced. The stem cell transplant can either be allogeneic or autologous.

  • An allogeneic transplant involves a person (donor) giving his/her stem cells to another person (recipient).
  • An autologous transplant involves a person giving his/her stem cells, which are then manipulated or processed and reintroduced to the same person.

Stem cells can also act as a target for a drug or other biologic. In this type of treatment, the drug activates a desired response from the stem cells that already exist in the patient’s tissues or organs.

The future of stem cell treatments is dependent on Induced Pluripotent Stem Cell (IPSC) technology. This technology involves reprogramming skin or blood cells into an embryonic-like pluripotent state. Cells in a pluripotent state can generate any other type of cell in the human body.

The promise of stem cells lies in the clinical trials

Unapproved therapies are those that have gone through the safety and efficacy process through clinical trials. Clinical trials are research studies performed in people to find out if a new treatment is safe and effective. There are approximately 1300 trails underway that use HSCs to address conditions such as[5]:

  • Cerebral Palsy
  • Diabetes
  • Multiple Sclerosis (MS)

Mesenchymal stem cells (MSCs), found in cord tissue and placental tissue, can differentiate into many types of cells and tissues. These include cartilage, skin, bone, and fat cells. There are more than 300 major MSC clinical trials underway worldwide for conditions such as:

  • Spinal Cord Injuries
  • Lung Cancer
  • Type 1 diabetes
  • Stroke

Finally, IPSC based clinical trials have been at the forefront of stem cell therapeutics. In 2019, heart surgeons used IPSC-derived cardiomyocytes to treat patients with heart disease. There is hope to treat patients with Parkinson’s Disease by 2022[6].

With so many ongoing trials, those who choose to invest in cord blood, placental tissue banking or live cell tissue banking are not just investing in the medicine of today, but recognize the future of stem cell and regenerative medicine.