NCT03984461 The Combined Use of PRP with Lipoaspirate And/or Bone Marrow Aspirate in Osteoarthritis
| NCT ID | NCT03984461 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Dr. Grant M. Pagdin |
| Condition | Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2020-09-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 240 participants in total. It began in 2020-09-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 with autoimmune disorders including rheumatoid arthritis and lupus. 11. 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. 12. Participants with allergies to lidocaine, heparin, or epinephrine.
Contact & Investigator
Stephen Rosenfeld, MD
STUDY CHAIR
Quorum Review IRB
Frequently Asked Questions
Who can join the NCT03984461 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 79 Years, studying Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03984461 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03984461 currently recruiting?
Yes, NCT03984461 is actively recruiting participants. Contact the research team at info@pagdinhealth.com for enrollment information.
Where is the NCT03984461 trial being conducted?
This trial is being conducted at Kelowna, Canada.
Who is sponsoring the NCT03984461 clinical trial?
NCT03984461 is sponsored by Dr. Grant M. Pagdin. The principal investigator is Stephen Rosenfeld, MD at Quorum Review IRB. The trial plans to enroll 240 participants.