The Combined Use of PRP With Lipoaspirate and/or Bone Marrow Aspirate in Osteoarthritis

  • STATUS
    Recruiting
  • End date
    Dec 15, 2025
  • participants needed
    240
  • sponsor
    Dr. Grant M. Pagdin
Updated on 15 September 2021
x-rays

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.

Description

The purpose of this study is 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.

A total of 240 participants will be randomly assigned to one of three treatment groups: Group A will receive PRP plus lipoaspirate, Group B will receive PRP plus bone marrow aspirate, and Group C will receive tri-partite therapy of PRP + lipoaspirate + bone marrow aspirate which allows for 80 in each group. The combination of biologic materials will be injected in to an arthritic joint.

Details
Condition Arthritis, Osteoarthritis, Arthritis and Arthritic Pain, Arthritis and Arthritic Pain (Pediatric), degenerative arthritis
Treatment Autologous cell therapy
Clinical Study IdentifierNCT03984461
SponsorDr. Grant M. Pagdin
Last Modified on15 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Capable of providing written informed consent and willing and able to adhere to all protocol requirements
Male or female at least 19 years of age at the time of providing written informed consent
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

BMI > 35
Arthroscopic surgery to the treatment joint within 12 months
Cortisone or HA injection within the last 3 months prior to stem cell injection
Inability to hold antiplatelet therapy according to treating provider prior to procedure
Kellgren & Lawrence Grade 4 Osteoarthritis
Participants with a platelet count less than 100 x 109
Participants with a Hemoglobin less than 100 g/L
Participants who have an active Infection with fever and/or elevated white blood cell (WBC) count
Participants with an active Cancer diagnosis
Participants with autoimmune disorders including rheumatoid arthritis and lupus
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
Participants with allergies to lidocaine, heparin, or epinephrine
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