Determine the Stem Cell Product Type: Autologous treatments (using a patient’s own cells) and allogeneic treatments (using donor cells) are both available but regulated differently. Autologous stem cell therapies meet the definition of a drug under the Food and Drugs Act.

Comply with Health Canada Regulations: Point-of-care procedures (where cells are processed and reinjected during a single visit) must comply with drug regulations if the cells undergo more than minimal manipulation or are used for non-homologous purposes (i.e., not for their original function).

Check if the treatment fits under Health Canada’s Advanced Therapeutic Products pathway for innovative therapies.

Clinical Trial Requirements: If offering novel or experimental stem cell therapies, ensure enrollment in a Health Canada-approved clinical trial. This applies if the therapy's safety and efficacy are not well-established.

Collaborate with the Office of Clinical Trials at Health Canada for adaptive trial designs and regulatory support.

Obtain Market Authorization: If the stem cell product is commercially distributed, ensure that it has market authorization. Unauthorized products could result in regulatory action, even if provided with patient consent.

Ethical and Safety Compliance: Align the treatment with the ethical guidelines for the use of human cells, tissues, and organs to safeguard patient safety.

Seek approval from institutional ethics boards, especially if treatments are part of research studies or trials.

Documentation and Patient Consent: Maintain accurate records of treatments, including the source and handling of stem cells.

Obtain informed consent from patients, ensuring they understand the risks, benefits, and experimental status (if applicable) of the treatment.

Provincial Licensing and Oversight: Comply with any provincial medical guidelines, such as those from the College of Physicians and Surgeons in provinces like Alberta, which may impose additional standards for regenerative medicine.