Bone Marrow Aspirate Concentrate (BMAC) vs Corticosteroid Injection

Conditions

• Osteoarthritis of the Knee

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

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.
• Corticosteroid injections — DRUG
  Current standard of treatment for OA of the knee is 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)

Study Details

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.

Key Dates

Start date

Jul 19, 2022

Status verified

Aug 2025

Primary completion

Dec 31, 2027

Completion

Mar 31, 2028

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

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).

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) ]

Central Contacts

• Carla M. Edwards, PhD
  312-563-5735
  [email protected]
• Jorge Chahla, MD
  (312) 432-2818
  [email protected]

Locations (1)

Find similar trials in Chicago, IL

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