NCT03984461

The Combined Use of PRP with Lipoaspirate And/or Bone Marrow Aspirate in Osteoarthritis

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Dr. Grant M. Pagdin · Academic / Other
• Sex: All
• Age: 19 Years – 79 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
BIOLOGICAL	Autologous cell therapy	Biologic material is harvested from the participant and re-injected into an osteoarthritic joint

Timeline

• Start date: 2020-09-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2019-06-13
• Last updated: 2024-11-15

Locations

1 site across 1 country: Canada