Recruiting

BMAC vs. Corticosteroid

Sponsor:

Rush University Medical Center

Code:

NCT05985785

Conditions

Osteoarthritis of the Knee

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Autologous bone marrow aspirate concentrate (BMAC)

Corticosteroid injections

Crossover Autologous bone marrow aspirate concentrate (BMAC)

Study Details

Brief 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

Study ID

NCT05985785

Start date

Jul 19, 2022

Status verified date

Aug, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

active comparator: Corticosteroid injection

Corticosteroid injection group (ARM 2) will receive a sham incision.

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).

Interventions

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)

Primary outcome measure

  • Visual analogue scale (VAS) for pain [ Time Frame: 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) ]
  • 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) ]

Central Contacts and Locations

Central contacts

Carla M. Edwards, PhD

312-563-5735carla_edwards@rush.edu

Jorge Chahla, MD

(312) 432-2818jorge.chahla@rushortho.com

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Carla M Edwards, PhD

312-563-5735carla_edwards@rush.edu

Principal Investigator:

Jorge Chahla, MD, PhD

More Information

Sponsor

Rush University Medical Center

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rush University Medical Center on 2026-08-24.