Autologous Bone Marrow Aspirate Concentrate in Patients Undergoing Meniscectomy

April 9, 2026 updated by: Rush University Medical Center

Prospective, Randomized, Double-blind Clinical Trial to Investigate the Efficacy of Autologous Bone Marrow Aspirate Concentrate Post-Meniscectomy

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
Procedure: Standard Meniscectomy
All subjects will undergo either a partial or complete meniscectomy to treat the torn meniscus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Knee Documentation Committee (IKDC) Score
Time Frame: One Year
The primary outcome measure will be the IKDC score at one year follow-up
One Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient reported outcomes throughout follow-up period
Time Frame: 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years
Patient reported outcomes will include change in scores from preoperative to Postoperative Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years
Synovial fluid analysis
Time Frame: 2 weeks, 6 weeks
To investigate any changes in synovial fluid markers of osteoarthritis.
2 weeks, 6 weeks
Radiographic analysis
Time Frame: 1 year, 2 years
The degree of OA will be examined in all patients preoperatively and at subsequent follow-up visits at 1 and 2 years.
1 year, 2 years
Patient reported outcomes throughout follow-up period (VAS)
Time Frame: 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years
Visual Analog Score (VAS)
7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years
Patient reported outcomes throughout follow-up period (IKDC)
Time Frame: 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years
International Knee Documentation Committee form (IKDC)
7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years
Patient reported outcomes throughout follow-up period (KOOS)
Time Frame: 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years
Knee injury and Osteoarthritis Outcome Score (KOOS)
7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years
Patient reported outcomes throughout follow-up period (SF-12)
Time Frame: 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years
(Short Form Health Survey) SF-12
7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rush University Medical Center

Investigators

  • Principal Investigator: Brian J Cole, MD, MBA, Midwest Orthopaedics at Rush

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2017

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

October 19, 2015

First Submitted That Met QC Criteria

October 19, 2015

First Posted (Estimated)

October 21, 2015

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15090903

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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