Bone Marrow Aspirate Concentrate (BMAC) vs Corticosteroid Injection (BMAC)

August 12, 2025 updated by: Rush University Medical Center

Bone Marrow Aspirate Concentrate vs Corticosteroid Injection for Symptomatic Osteoarthritis (OA) of the Knee: A Randomized Controlled Trial

Prospective single-masked (study participant will be masked), randomized controlled trial to examine the influence of BMAC on patient-reported outcomes (PROs) in patients with primary knee osteoarthritis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to examine the influence of BMAC on patient-reported outcomes (PROs) in patients with primary knee osteoarthritis and compare that to patients receiving corticosteroid injections with six-month follow-up.

All patients who sign the consent form will be enrolled in the study and randomized to one of the two treatment arms. This study will aim to recruit and enroll a total of 100 patients (50 per group). Treatment arms include BMAC injections (ARM1) and corticosteroid injections (ARM 2). Patients in the corticosteroid injection group (ARM 2) will receive a sham incision. Follow-up will be up to six months (12-months if crossover (ARM 3)).

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 Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Contact:
        • Principal Investigator:
          • Jorge Chahla, MD, PhD
        • Sub-Investigator:
          • Adam Yanke, MD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients between the ages of 18-70
  • Long standing knee pain from osteoarthritis (KL grade 2-3) despite conventional treatments such as activity modification, weight loss, physical therapy, analgesics, nonsteroidal anti-inflammatory drugs, or injection therapy for at least 6 weeks
  • 7-day average pain score of at least 4 on VAS scale

Exclusion Criteria:

  • Systemic diseases (Diabetes, malignancies, infections, etc.)
  • Post-traumatic arthritis
  • Patient had intra-articular injection on affected knee in last three months

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Autologous (from subject to self) bone marrow aspirate concentrate (BMAC) injections
Autologous bone marrow aspirate concentrate (BMAC) will be removed from the subject knee body with a needle, processed and concentrated by an FDA-approved centrifuge (separator) system. The concentrated cells will be injected into the subject knee. "Autologous" means that the subject is receiving back their own cells that were collected.
Other: Autologous bone marrow aspirate concentrate (BMAC)
Bone marrow aspirate concentrate BMAC is a biologically substance harvested from a patient for autologous use. Bone marrow aspirate concentrate (BMAC) has been determined by the FDA to be a minimally manipulated biologic prepared for autologous use and does not require premarket FDA approval for clinical use.
Active Comparator: Corticosteroid injection
Corticosteroid injection group (ARM 2) will receive a sham incision.
Drug: Corticosteroid injections
Current standard of treatment for OA of the knee is corticosteroid injection.
Other: Crossover Group
Any patient in the corticosteroid injection group that shows no improvement in pain after 24 weeks (12 month follow-up if crossover), per physician discretion, will be allowed crossover to the BMAC injection group (ARM 3).
Other: Crossover Autologous bone marrow aspirate concentrate (BMAC)
Subjects who participate in this study and who are randomized to receive the BMAC may experience decreased pain and increased functionality after the injection compared to those that receive a corticosteroid injection. As such, participants who continue to have pain after a corticosteroid injection will be allowed to crossover to a BMAC injection at 24 weeks or 6 months post-surgery.(ARM 3)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale (VAS) for pain
Time Frame: Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)
The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line.
Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)
Intermittent and Constant Osteoarthritis Pain (ICOAP)
Time Frame: Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)
13 items survey that assess two forms of pain reported by people with osteoarthritis: intermittent and constant pain.
Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)
The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL)
Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)

Collaborators and Investigators

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

Sponsor

Rush University Medical Center

Investigators

  • Principal Investigator: Jorge Chahla, MD, Rush University Medical Center Associate Professor and Surgeon

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)

July 19, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

August 2, 2023

First Submitted That Met QC Criteria

August 2, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

August 13, 2025

Last Update Submitted That Met QC Criteria

August 12, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21052504

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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