Combining PRP with fat and bone marrow for treating osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 Should a participant become pregnant during the study, she will be withdrawn from further treatment and imaging, but can participate in symptom follow-up.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 it's running

• Pagdin Health
  Kelowna, British Columbia, Canada Recruiting

Study contacts

• Study coordinator: Grant Pagdin, MD
• Email: info@pagdinhealth.com
• Phone: 250-717-3200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.