Bone Marrow Aspirate Concentrate vs Corticosteroid Injection for Symptomatic Osteoarthritis (OA) of the Knee: A Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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
Locations
United States
Illinois
Rush University Medical Center
RECRUITING
Chicago
Contact Information
Primary
Carla M. Edwards, PhD
carla_edwards@rush.edu
312-563-5735
Backup
Jorge Chahla, MD
jorge.chahla@rushortho.com
(312) 432-2818
Time Frame
Start Date: 2022-07-19
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 100
Treatments
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).
Related Therapeutic Areas
Sponsors
Leads: Rush University Medical Center