Bone Marrow Aspirate Concentrate (BMAC) vs Corticosteroid Injection

Osteoarthritis of the Knee Clinical Trial

— BMAC  

Official title:

Bone Marrow Aspirate Concentrate vs Corticosteroid Injection for Symptomatic Osteoarthritis (OA) of the Knee: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05985785
• Other study ID #: 21052504
• Status: Recruiting
• Phase: N/A
• Start date: July 19, 2022
• Est. completion date: March 31, 2026

Study information

• Verified date: August 2023
• Source: Rush University Medical Center
• Contact: Carla M. Edwards, PhD
• Phone: 312-563-5735
• Email: carla_edwards[@]rush.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The purpose of this study is to examine the influence of BMAC on patient-reported outcomes (PROs) in patients with primary knee osteoarthritis and compare that to patients receiving corticosteroid injections with six-month follow-up.

All patients who sign the consent form will be enrolled in the study and randomized to one of the two treatment arms. This study will aim to recruit and enroll a total of 100 patients (50 per group). 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)).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

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)

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)