Autologous Bone Marrow Aspirate Concentrate in Patients Undergoing Meniscectomy

Study Purpose

The proposed research study aims to evaluate the effects of autologous bone marrow aspirate concentrate (BMAC) on the development and progression of osteoarthritis (OA) in patients undergoing meniscectomy. This prospective, randomized, double-blind clinical trial will compare patient-reported outcomes, specifically IKDC scores between patients who receive BMAC post-meniscectomy and those who receive a saline control injection. The study will also compare physical examination, MRI, radiographs, and synovial fluid analysis. Our hypothesis is that those who receive the autologous BMAC injection after the procedure will have better outcomes than those who do not.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Rush University Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Brian J Cole, MD, MBA
Principal Investigator Affiliation Midwest Orthopaedics at Rush
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Osteoarthritis Post-meniscectomy
Additional Details

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 & Interventions


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.


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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Rush University Medical Center, Chicago, Illinois




Rush University Medical Center

Chicago, Illinois, 60612

Site Contact

Barb L Ramsey, RN

[email protected]