Stem Cell Clinical Trial
Stem Cell Research Project Update
Hi there. It's Dr. Grant Pagdin. I figured it was about time that I gave you an update as to my clinical research project investigating the use of stem cells for osteoarthritis. We got the Health Canada approval to launch our project in January of 2020. Then we got ethics approval in February of 2020, and unfortunately, things came to a halt with the onset of the COVID pandemic in March of 2020; the office was closed and we weren't seeing any patients in person.
We didn't actually enroll our first subject in the project until September of 2020. Of course, the uptake was a bit slow because people were reluctant to travel. So here we are in July of 2022, and we have enrolled a total of 85 subjects so far out of a projected number of 240 in the complete cohort.
Now, our subjects get randomized into one of three treatment arms. One group gets a combination of PRP with lipoaspirate, the second group gets PRP with bone marrow aspirate, and the third group gets a combination of all three: PRP, lipoaspirate and bone marrow aspirate.
The joints we are investigating include shoulders, elbows, wrists, hips, knees, and ankles. And the outcome measures that we are tracking include the visual analog scale for pain, as well as the SF 12, which is a 12 question function questionnaire. We track the outcomes at baseline, 6 months, 12 months, and 24 months.
Now, for the purposes of Health Canada, they want to make sure that these type of therapies are both safe and effective, so not only do we report to them our outcome measures, but also any adverse events. And these are tracked at every follow up visit.
In addition, to assure quality control, we send away a small number of our samples for cell counting. When we send away our blood to analyze the PRP, we want to make sure that it truly is leukocyte poor and red cell poor, and that it concentrates our platelets by a factor of four to five times baseline, and this, we have been able to confirm.
With regard to our lipoaspirate and bone marrow aspirate, we are interested in the total number of mesenchymal stem cells. These are the cells that are in the lineage of cartilage, muscle, tendon, ligament, and so on, so we get excellent cell viability. We ship our samples overnight and we have the analysis performed the next morning. Cell viability is excellent, and the numbers of the mesenchymal stem cells that come out of a typical sample of bone marrow would be about 100,000 cells per CC. Whereas the number of mesenchymal stem cells coming out of fat is about 4 to 5 times that much, 400,000 to 600,000 mesenchymal stem cells per CC from our fat samples. So we're getting excellent numbers of stem cells and excellent cell viability.
Now, in terms of outcomes, this is what people are really interested in knowing: how are the subjects doing? Well, we followed about 60 of our subjects out to between 6 to 12 months now of follow up, and at least 75% of these are reporting substantial improvements in pain and function, and these would be of a clinically meaningful amount. Now, it doesn't seem to matter which study group they were randomly assigned to. All of the groups are improving to a similar extent, so we haven't yet been able to tease out any differences between those three treatment arms.
Now, there's a smaller percentage of people that report some improvements, but they don't quite reach the threshold that we set for being a clinically meaningful improvement. And then there are a small number of our subjects that have failed to have any improvement whatsoever, but we can't expect that any given treatment is going to fix every participant, every time.
So, we're quite pleased with how the early results are going, and we certainly have room to enroll numerous more candidates over the next couple of years, then we will be performing our two year follow up. So, the total length of time that I expect that it will take me to wrap up this project will be about four more years.
We look forward to giving you some future updates as more information becomes available.