Combining PRP with fat and bone marrow for treating osteoarthritis

A Phase II, Randomized, Parallel-Group Study to Investigate the Combined Use of PRP with Lipoaspirate And/or Bone Marrow Aspirate in Osteoarthritis

This study is testing whether combining platelet-rich plasma with fat or bone marrow can help people with osteoarthritis feel better in their major joints.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 19 Years to 79 Years
• Sex: All
• Sponsor: Pagdin Health (Academic / other)
• Locations: 1 site (Kelowna, British Columbia)
• Trial ID: NCT03984461 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of combining platelet-rich plasma (PRP) with lipoaspirate and/or bone marrow aspirate in treating osteoarthritis in major joints. A total of 240 participants will be randomly assigned to one of three treatment groups: one receiving PRP plus lipoaspirate, another receiving PRP plus bone marrow aspirate, and the last group receiving all three treatments together. The outcomes of these combinations will be compared to determine the most effective approach for alleviating symptoms of osteoarthritis.

Who should consider this trial

Good fit: Ideal candidates are adults aged 19 and older with evidence of osteoarthritis in a major joint and Kellgren & Lawrence Grades 1-3.

Not a fit: Patients with severe osteoarthritis (Grade 4), high BMI, or recent joint surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve joint function and reduce pain for patients suffering from osteoarthritis.

How similar studies have performed: Other studies have shown promising results with similar combinations of biologic therapies for osteoarthritis, indicating potential for success.

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.

Where this trial is running

Kelowna, British Columbia

• Pagdin Health — Kelowna, British Columbia, Canada (Recruiting)

Study contacts

• Study coordinator: Grant Pagdin, MD

Conditions Osteoarthritis; Platelet Rich Plasma; Micronized Lipoaspirate; Bone Marrow Aspirate