The Combined Use of PRP with Lipoaspirate And/or Bone Marrow Aspirate in Osteoarthritis
Recruiting now · Phase 2
Conditions studied: Osteoarthritis
In brief
To demonstrate the efficacy of the combined use of platelet-rich plasma (PRP) with lipoaspirate and/or bone marrow aspirate in osteoarthritis of major joints, and to compare the outcomes achieved using three combinations: PRP plus lipoaspirate, PRP plus bone marrow aspirate, and PRP plus both lipoaspirate and bone marrow aspirate.
Key facts
- Study ID
- NCT03984461
- Run by
- Dr. Grant M. Pagdin
- People needed
- 240
- Starts
- 2020-09-01
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2024-11-15
Who can join
Age: 19 and older, up to 79. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Capable of providing written informed consent and willing and able to adhere to all protocol requirements.
- Male or female at least 19 years of age at the time of providing written informed consent.
- Evidence of OsteoArthritis in a major joint requires recent (within one year) imaging, either by x-ray or MRI. Kellgren \& Lawrence Grades 1-3 are accepted for participation.
You may not qualify if…
- BMI > 35
- Arthroscopic surgery to the treatment joint within 12 months
- Cortisone or HA injection within the last 3 months prior to stem cell injection
- Inability to hold antiplatelet therapy according to treating provider prior to procedure
- Kellgren \& Lawrence Grade 4 Osteoarthritis
- Participants with a platelet count less than 100 x 109
- Participants with a Hemoglobin less than 100 g/L
- Participants who have an active Infection with fever and/or elevated white blood cell (WBC) count
- Participants with an active Cancer diagnosis.
- Participants with autoimmune disorders including rheumatoid arthritis and lupus.
- Women who are pregnant will be excluded due to the possibility of fetal harm associated with x-rays. Should a participant become pregnant during the study, she will be withdrawn from further treatment and imaging, but can participate in symptom follow-up. Female participants of childbearing potential will be counseled at screening about contraception and encouraged to use birth control for the duration of the study.
- Participants with allergies to lidocaine, heparin, or epinephrine.
Where it is running
- Pagdin Health — Kelowna, British Columbia, Canada (enrolling)
Full record on ClinicalTrials.gov
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