Stem Cell Clinical Trial

Stem Cell Therapy Clinical Trial Application Update

November 26, 2019

Back in May, Health Canada sent out letters to all of the clinics in Canada that were doing work with stem cells to indicate that we must immediately stop until we have an official approval of Health Canada to conduct a clinical trial. I had been anticipating this request, so I had begun dialogue with Health Canada back in 2018 to have a clinical trial approved.

Our clinical trial aims to compare three different types of treatments for osteoarthritis and our project will be open to Canadians between the ages of 19 and 79 with osteoarthritis in any major joint.

There is no sponsorship from industry or corporations, so patients who want to participate in this project will have to pay the cost of having this type of treatment.

We had initially submitted this project to Health Canada in July 2019, but they had a number of concerns and sent it back to us requesting substantial amounts of additional information. I spent the rest of the summer collating this information which included some basic research in animal studies as well as a lot of background information in human trials using these types of cells for osteoarthritis. I have worked diligently compiling this information and we are now in the final stages of having all of the documents ready to submit to Health Canada.

I have hired a consultant to help me to make sure that all of the documents are in order and we expect to be able to submit this complete package to Health Canada in the early part of December 2019. Health Canada then has 10 days to review the documents for completeness. Once they are satisfied that the submission is complete, they will then undergo a detailed analysis of the protocol which will take a further 30 days.

There likely will be some back and forth discussions to help to clarify any issues over that period of time, which means it puts us into the middle of January 2020 before we would be in a position to finally receive the approval of Health Canada to get the project underway. The soonest we would begin to enroll candidates into this project would be the early part of March 2020.

If, in the meantime, you are considering having Stem Cell therapy outside of Canada, it would be important that you ask some very critical questions:

  1. Where do the stem cells come from? If the clinic you're hoping to attend is using stem cells that derive from birth products such as amniotic fluid, placental extracts, umbilical cords, you can rest assured they will be absolutely no living stem cells in that injection. The processing that takes place with these birth products eliminates all living cells. You'll simply be getting a vile of powder that might contain a little bit of proteins, but there will be no stem cells in there. The preferred source of stem cells, of course, is to take them from your own body. If they're harvested from your own body, then you can be certain that these cells will be live and be viable.
  2. Ascertain the level of training of the individual doing the injections. You would want to make sure that this is a physician who has been adequately trained in stem cell medicine to understand not only how to harvest these, but also how to inject them precisely into the area where it's required.
  3. Inquire about how these injections are guided. It should be with a bedside ultrasound or with fluoroscopy, a type of x-ray.
  4. Determine the cost of these procedures as sometimes these clinics can charge exorbitant fees.
  5. How are these clinics tracking their outcome and do they put all of the patients into a database which can be shared among other providers?
  6. What kind of follow up do these clinics offer? If you, for instance, are heading to central America or Southeast Asia to have a stem cell procedure, what would happen if you get a complication? Would you have to go back to that clinic again and would they look after you afterwards?

I understand that the news about these delays that we've been facing with Health Canada are frustrating to many of you as they are to me, but rest assured, we will endeavor to keep you abreast of how things progress over these next few weeks.

If you would like to have a complimentary call with me to discuss the options that are available in Canada for things like mild to moderate osteoarthritis, sports injuries such as tennis elbow, Achilles tendons, a patellar tendons, and rotator cuff problems, I would be pleased to schedule a no cost, no obligation consultation at your request. Please contact our office at: 250-717-3200

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