Stem Cell Clinical Trial
Stem Cell Therapy Clinical Trial Application Update
February 2, 2020
I sure am pleased to announce that finally, after a year and a half of hard work and much deliberation, we received our letter of no objection from Health Canada so we are going ahead with our research project investigating the use of stem cells for osteoarthritis.
As you can imagine, the clinic is in a flurry of activity right now as we put all the finishing touches together to be able to launch this project. We hope to be screening participants at the beginning of March and to start these procedures in the middle of March.
To be included in this research project, you need to meet certain criteria. The specific inclusion criteria are: you need to be capable of providing written informed consent; you need to be a Canadian resident age 19 -79 years; you need to have evidence of osteoarthritis in one of your major joints, so this would include shoulder, elbow, wrist, hip, knee or ankle (please keep in mind that we do not treat any back or spine problems); you need to have some symptomatic complaints of pain or reduced function in that particular joint for at least three months prior to enrolment. You would be excluded from participating if you have severe obesity, which means a BMI of greater than 35; if you have had arthroscopic surgery to the joint in question within the last 12 months; if you've had an injection of cortisone or hyaluronic acid within the last three months; if you've had an injection of PRP to this joint within the last six months. Another exclusion would be if you are on a blood thinner and your doctor says you are not allowed to stop that for two or three days prior to being treated; we also exclude patients that have extremely severe end stage osteoarthritis, (that would be called a grade four stage).
You would be excluded if your platelet count was less than a hundred or if your hemoglobin was less than a hundred; we would also exclude participants who have an active infection, so if you had a fever or an elevated white blood cell count; participants with active cancer; participants with autoimmune disorders, like Rheumatoid Arthritis, Lupus or Crohn's Disease; and women who are pregnant would be excluded from participating because of the possibility of fetal harm associated with x-rays. Now, if a female becomes pregnant while they are in the study, we would simply withhold any additional treatments and x-rays, but we would still like them to participate in the follow up. The other thing we would take into consideration is if a person were allergic to lidocaine, heparin or epinephrine.
The cost to participate in this project is $5,900 which is payable by the participant when they sign up. The reason there is a cost is because we don't have the backing of industry, we don't have a pharmaceutical company here and we don't have independent financial support, so this project needs to be paid for by the participant. We've tried to keep the cost as modest as possible while still covering off the expenditures including surgical equipment and supplies. Of course, all of the equipment that we use for these procedures is single use only disposable products which completely eliminates any risk of cross contamination and infection.
To participate in this research project, it will require a total of seven encounters. The first encounter is the intake assessment with the nurse that can be done over the telephone. The next three are visits that you need to make here in person to the clinic in Kelowna. At your first clinic visit, you will be randomized to one of three groups: the first group would get a combination of fat and platelets, the second group gets a combination of bone marrow and platelets, the third group gets a combination of fat and bone marrow and platelets. Neither the investigator nor the participant is going to know which group they are assigned to until they open the envelope. You will then come back to the clinic for two follow up injections of just platelets. So, a total of three visits here to the clinic, and these visits are spaced almost exactly four weeks apart.
Finally, there'll be three follow up visits that can be done over the telephone, and these are very important as they allow us to track your outcome, as well as the possibility of any side effects or adverse events that could happen. We want to do these visits at 6 months, 12 months, and 24 months after your initial study procedure. It would be very important that you commit to participating in every one of these visits.
If you would like to participate in this ground-breaking research project, the first of its kind in Canada, please click on the link below to see if you would qualify.
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