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Bone Marrow Aspirate Concentrate (BMAC) vs Corticosteroid Injection

NCT05985785 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-08-13

No results posted yet for this study

Summary

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.

Conditions

  • Osteoarthritis of the Knee

Interventions

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.

DRUG

Corticosteroid injections

Current standard of treatment for OA of the knee is corticosteroid injection.

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)

Sponsors & Collaborators

  • Rush University Medical Center

    lead OTHER

Principal Investigators

  • Jorge Chahla, MD · Rush University Medical Center Associate Professor and Surgeon

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-19
Primary Completion
2027-12-31
Completion
2028-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05985785 on ClinicalTrials.gov