PRP + Cell Therapy for Osteoarthritis

Phase 2

Recruiting

Research Sponsored by Dr. Grant M. Pagdin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female at least 19 years of age at the time of providing written informed consent

Be older than 18 years old

Must not have

Participants who have an active Infection with fever and/or elevated white blood cell (WBC) count

Arthroscopic surgery to the treatment joint within 12 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the sf12-v2 will be measured at baseline (week 1) through to the end of the study (week 104). to test for improvement, comparisons to baseline will be made at 6 months (week 26,) 12 months (week 52) and 24 months (week 104).

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether combining platelet-rich plasma (PRP) with either lipoaspirate or bone marrow aspirate can improve outcomes in osteoarthritis patients, compared to using PRP alone.

Who is the study for?

This trial is for adults over 19 with Osteoarthritis in a major joint, confirmed by recent imaging. They must be able to consent and follow the study plan. Excluded are those with BMI >35, recent joint surgery or injections, certain medication restrictions, severe arthritis (Grade 4), low platelet or hemoglobin levels, active infection or cancer, pregnant women, and those with autoimmune diseases or allergies to specific medications.

What is being tested?

The trial tests how effective PRP therapy combined with lipoaspirate and/or bone marrow aspirate is for Osteoarthritis. Participants will receive one of three treatment combinations: PRP plus lipoaspirate; PRP plus bone marrow aspirate; or PRP with both lipoaspirate and bone marrow aspirate.

What are the potential side effects?

Potential side effects may include discomfort at injection sites, swelling, bruising from needle insertion for collecting fat/bone marrow cells used in treatments. There's also a risk of infection post-procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 19 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently have an infection with a fever or high white blood cell count.

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I have not had arthroscopic surgery on the joint in question in the last year.

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I currently have an active cancer diagnosis.

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My condition is severe osteoarthritis.

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My doctor says I can't stop my blood thinning medication before a procedure.

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My BMI is over 35.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the vas will be measured at baseline (week 1) through to the end of the study (week 104). to test for improvement, comparisons to baseline will be made at 6 months (week 26,) 12 months (week 52) and 24 months (week 104).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the vas will be measured at baseline (week 1) through to the end of the study (week 104). to test for improvement, comparisons to baseline will be made at 6 months (week 26,) 12 months (week 52) and 24 months (week 104).

This trial's timeline: 3 weeks for screening, Varies for treatment, and the vas will be measured at baseline (week 1) through to the end of the study (week 104). to test for improvement, comparisons to baseline will be made at 6 months (week 26,) 12 months (week 52) and 24 months (week 104). for reporting.