Bone Marrow Aspirate Concentrate (BMAC) vs Corticosteroid Injection

NCT05985785 | Recruiting

• 1 other identifier: 21052504
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Visual analogue scale (VAS) for pain

  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)

  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)

  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)

Study Arms (3)

Autologous (from subject to self) bone marrow aspirate concentrate (BMAC) injections

EXPERIMENTAL

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)

Corticosteroid injection

ACTIVE COMPARATOR

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

Drug: Corticosteroid injections

Crossover Group

OTHER

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)

Interventions

Autologous bone marrow aspirate concentrate (BMAC) OTHER

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.

Autologous (from subject to self) bone marrow aspirate concentrate (BMAC) injections

Corticosteroid injections DRUG

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

Corticosteroid injection

Crossover Autologous bone marrow aspirate concentrate (BMAC) OTHER

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)

Crossover Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• day average pain score of at least 4 on VAS scale

You may not qualify if:

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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Jorge Chahla, MD

  Rush University Medical Center Associate Professor and Surgeon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carla M. Edwards, PhD

CONTACT

312-563-5735; carla_edwards@rush.edu

Jorge Chahla, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: August 2, 2023
• First Posted: August 14, 2023
• Study Start: July 19, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: August 13, 2025

Record last verified: 2025-08

Locations

US (1)