Bone Marrow Aspirate Concentrate (BMAC) vs Corticosteroid Injection
NCT ID: NCT05985785
Last Updated: 2025-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2022-07-19
2028-03-31
Brief Summary
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Detailed Description
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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)).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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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.
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.
Corticosteroid injection
Corticosteroid injection group (ARM 2) will receive a sham incision.
Corticosteroid injections
Current standard of treatment for OA of the knee is corticosteroid injection.
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).
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)
Interventions
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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.
Corticosteroid injections
Current standard of treatment for OA of the knee is corticosteroid injection.
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)
Eligibility Criteria
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Inclusion Criteria
* 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
* Post-traumatic arthritis
* Patient had intra-articular injection on affected knee in last three months
18 Years
70 Years
ALL
No
Sponsors
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Rush University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Jorge Chahla, MD
Role: PRINCIPAL_INVESTIGATOR
Rush University Medical Center Associate Professor and Surgeon
Locations
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Rush University Medical Center
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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21052504
Identifier Type: -
Identifier Source: org_study_id
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