Clinical Trial Finder

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 1-3 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 4 on flexion posterior-anterior (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/viscosupplementation/ (platelet rich plasma) PRP injection within 6 weeks

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.

Arms

Experimental: Meniscectomy with Bone Marrow Aspirate Concentrate (BMAC)

Subjects will undergo the scheduled meniscectomy procedure. Following the procedure the investigator will make a small incision and create the marrow access channel in the proximal tibia. The experimental group will then have bone marrow harvested and BMAC will be prepared using a BMAC harvesting system. The automated centrifuge system rapidly concentrates cellular contents and growth factors in bone marrow aspirate using flow cytometry. The BMAC will be injected intra-articularly.

Placebo Comparator: Meniscectomy with Placebo

Subjects will undergo the same meniscectomy procedure and will also have an incision and marrow access channel made in the proximal tibia, however no bone marrow will be harvested. The control group will have a placebo injection of saline into the affected knee.

Interventions

Biological: - Bone Marrow Aspirate Concentrate

Subjects undergoing autologous bone marrow aspirate concentrate will receive an intra-articular injection into the affected knee.

Procedure: - Standard Meniscectomy

All subjects will undergo either a partial or complete meniscectomy to treat the torn meniscus.