Evaluating Bone Marrow Aspirate and Lipoaspirate Micronized with Platelet-Rich Plasma Injections Compared to Placebo for Knee Osteoarthritis Treatment

What this Trial Is About

Researchers are evaluating two minimally manipulated autologous cellular treatments for knee osteoarthritis OA in a phase IIIII multi-center, double-blinded, randomized, placebo-controlled trial. The study compares bone marrow aspirate BMA injection and a combination of lipoaspirate micronized LAM with leukocyte-poor platelet-rich plasma LP-PRP injections against placebo saline injections. The goal is to measure pain improvement and functional outcomes in adults with knee OA. Participants will receive either an intra-articular injection of BMA collected from bone marrow aspiration or an injection of LAM plus LP-PRP prepared from lipoaspirate and whole blood. Each treatment is compared to a placebo saline injection group. Bone marrow aspiration or lipoaspiration plus blood draw are performed before injections. Injections are ultrasound-guided and given as a single dose. Two independent studies are conducted under one protocol, each with a treatment and placebo group. Participants will complete patient-reported outcome questionnaires at baseline, 3, 6, and 12 months post-injection. Biological samples including blood, synovial fluid, and urine will be collected at baseline and 6 months. Safety is monitored through adverse event reporting and X-rays at 6 months. The main outcome is a pain score improvement at 6 months. Other measures include functional scores, health-related quality of life, treatment satisfaction, and health care usage. Total participation lasts up to 12 months post-injection.

Autologous BMA vs Saline and LAM + LP-PRP vs Saline Evaluations in Knee OA