Clinical Trial Applications

July 2020

A whole year has now passed since the new regulation was set in July by Health Canada. We at Vancouver Regenerative Health and Wellness Centre would like to first and foremost thank everyone for their continued support and patience.

In May 2019 we received a letter from Health Canada to cease operations until we receive a No Objection Letter (NOL) for Clinical Trial Application (CTA). We understand that many were disappointed to hear this as were we at Vancouver Regenerative Health and Wellness centre. The great news is that we have taken the preliminary steps in applying to Health Canada for a CTA. Although it has been an extensive process we could not be more thrilled and excited for this opportunity. We are currently awaiting Health Canada’s response before we submit additional paperwork.

To give you a little insight, the CTA is composed of many technical components that require extensive expertise and detailed investigation. With further research we have updated our procedures for lipoaspirate to incorporate Platelet Rich Plasma (PRP) hence the additional time required to prepare the CTA.

Unfortunately due to COVID-19, there is likely to be further delay in the already lengthy process.

Rest assured, our team is working non-stop to bring lipoaspirate therapy to Canadians despite this setback.

If you have any more questions, please do no hesitate to contact us directly for more information.

 

 


Health Canada Regulatory Update (2019)

Vancouver Regenerative Health and Wellness 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.

VRHWC 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.