Stem Cell Clinical Trial
Stem Cell Research Project Update
I'm Dr. Grant Pagdin. I'm a graduate of the University of British Columbia medical school and I have a fellowship in family practice. I've also done board certification with the American Academy of Anti-aging and Regenerative Medicine and I have a fellowship in stem cell medicine. More recently, I was appointed to be a fellow of the Interventional Orthobiologics Foundation.
I developed a special interest in regenerative medicine back in 2014, using a combination of PRP and fat stem cells and bone marrow stem cells for various sports injuries, as well as for osteoarthritis. Now in 2019 Health Canada changed the rules and indicated that if we were to use these types of products for orthopedic applications, we needed to have a specific clinical trial with Health Canada approval. I actually was anticipating some of this kind of regulatory change, so I started a dialogue with Health Canada in August of 2018 to see if I could put together a clinical trial that would meet with their approval. After much back and forth, we did get the approval of Health Canada to have the first of its kind trial using these biologic materials for osteoarthritis. We received this approval in January of 2020.
Our research project is currently enrolling participants. We want to get a total of 240 participants, which are going to be divided into three groups of 80. All of the groups will get active treatment either with fat stem cells or bone marrow stem cells, or a combination of both fat and bone marrow. There is no placebo arm in this Phase Two clinical trial.
Once a person participates with the initial set of injections, they would be back to see us again for two follow-up injections of platelet-rich plasma followed by three telephone visits that take place at 6 months, 12 months and 24 months. We want to make sure that we track the long-term outcome of these procedures, as well as monitor for safety and any possible side effects.
The cost of this project is shared between my corporation, Dr. G Pagdin Inc., and the participant. This is because we have no independent industry sponsorship or pharmaceutical company sponsorship. So the cost to the participant is $5,900 and that includes your initial treatment with PRP and stem cells plus the two follow-up injections of PRP. Note that there's no GST or PST on that, so that's the total cost. We do have third-party financing options available if you're interested.
So if you're interested in participating in this research project, please click the green button immediately below for the participant questionnaire and then my office will be in touch with you to provide some further information.