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Recruiting Phase 2 NCT03984461

The Combined Use of PRP with Lipoaspirate And/or Bone Marrow Aspirate in Osteoarthritis

Trial Parameters

Condition Osteoarthritis
Sponsor Dr. Grant M. Pagdin
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 240
Sex ALL
Min Age 19 Years
Max Age 79 Years
Start Date 2020-09-01
Completion 2027-12
Interventions
Autologous cell therapy

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: 1. Capable of providing written informed consent and willing and able to adhere to all protocol requirements. 2. Male or female at least 19 years of age at the time of providing written informed consent. 3. 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. Exclusion Criteria: 1. BMI \> 35 2. Arthroscopic surgery to the treatment joint within 12 months 3. Cortisone or HA injection within the last 3 months prior to stem cell injection 4. Inability to hold antiplatelet therapy according to treating provider prior to procedure 5. Kellgren \& Lawrence Grade 4 Osteoarthritis 6. Participants with a platelet count less than 100 x 109 7. Participants with a Hemoglobin less than 100 g/L 8. Participants who have an active Infection with fever and/or elevated white blood cell (WBC) count 9. Participants with an active Cancer diagnosis. 10. Participants wi

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