Recent studies have demonstrated both the safety of BMAC intra-articular injection and improvements in subjective, patient reported outcomes in patients with existing knee OA. Unfortunately these studies were largely uncontrolled, underpowered, and/or retrospective in nature. Additionally, a recent prospective, randomized clinical study of allograft mesenchymal stem cells (MSCs) injected at a separate time point post surgical intervention has highlighted the ability of MSCs to increase meniscal volume and improve knee pain following injection.
This will be the first study to examine the effects of autograft BMAC intra-articular injection in a single-stage procedure and in a prospective, randomized, double-blind fashion. The results of this study, if the null hypothesis is rejected, will have far-reaching implications for the standard of care in meniscal treatment and on OA progression in the knee. Additionally, if the results of this study are favorable in reduction of OA progression this study will change the surgical approach to all axial, synovial joints including the shoulder, elbow, wrist, hip, and ankle.