Health Canada Regulatory Update

Vancouver Stem Cell Treatment Centre is committed to providing treatments in the safest and most effective way possible for our patients. We have been providing adipose-derived autologous stem cell treatments and HcPRP for musculoskeletal/joints and other various conditions with a commitment to providing these treatments solely to those with a strong potential of success.

Health Canada has recently made a regulatory statement change that classifies all stem cell therapies “drugs” and have therefore deemed that stem cells from your own body are regulated under the Food and Drug Act of Canada.  Every clinic in Canada performing any medical procedures using biologic materials must either obtain a new drug permit or have a registered clinical trial with Health Canada which will provide the necessary NOL (No Objection Letter).

Health Canada’s statement insists that stem cell therapies is the process of “manufacturing a drug.”  However, as indicated in the “Health Canada Consolidated Policy Statement – Autologous Cell Therapy Products”, Statement 2:

Autologous cell therapy products, “except lymphohemopoietic cells which have been minimally manipulated and are intended for homologous use in transplantation” like other new drugs are regulated…

Your autologous stromal vascular fraction contains lymphohematopoietic cells and therefore should qualify as an exemption.

We have been ordered by Health Canada to suspend providing autologous stem cell treatments while we await our request for more clarity on their regulation.  VSCTC is committed to being in compliance with the various regulatory bodies.

VSCTC has submitted a Clinical Trial Application to Health Canada requesting approval to conduct research using adipose-derived stem cells for osteoarthritis. This protocol has previously been sent to a research ethics board and has IRB approval. We are currently awaiting a No Objection Letter (NOL) for our research.

Your feedback is very important for Health Canada and the Minister of Health to hear. Please take the time to email us and we will pass your input along:

info@vanstemcell.com

Alternatively, you can email or write to the Minister of Health of Canada and the BC Minister of Health:

Canadian Minister of Health (Honourable Ginette Petitpas Taylor)
Email: Ginette.PetitpasTaylor@parl.gc.ca

BC Minister of Health (Honourable Adrian Dix):
Email: HLTH.Minister@gov.bc.ca
**we are happy to provide the contact information for your MP or your provincial Minister of Health as well.

We appreciate your patience while we wait for further guidance and look forward to helping you with all of the other treatments we provide!  We look forward to having the right to try and right to alternative medicine when deciding the future of your own health in Canada.

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