Autologous Bone Marrow Aspirate Concentrate in Patients Undergoing Meniscectomy

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.

Inclusion Criteria:

- Subject is greater than 18 years old

- Written informed consent is obtained

- Subject is determined to have a symptomatic meniscal tear requiring a meniscectomy

- Meniscal pathology is confirmed through MRI and arthroscopically

- Subject agrees to all follow-up evaluations

- Osteoarthritis Kellen-Lawrence grade 1-2 on flexion PA and extension AP views

Exclusion Criteria:

- Any subject lacking decisional capability

- Unwillingness to participate in the necessary follow-up

- Subject is pregnant or may become pregnant

- History of diabetes mellitus

- History of rheumatoid arthritis or other autoimmune disorder

- History of solid organ or hematologic transplantation

- Diagnosis of a non-basal cell malignancy within the preceding 5 years

- Infection requiring antibiotic treatment within the preceding 3 months

- Osteoarthritis Kellen-Lawrence grade 3 or 4 on flexion posteroanterior (PA) or
extension anteroposterior (AP) views

- Prior surgery on the index meniscus

- Concomitant surgery such as ligament surgery or cartilage repair or restoration

- Infection

- Prior cortisone/viscoscupplemtation/PRP injection within 6 weeks