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Bone Marrow Aspirate Concentrate (BMAC) vs Corticosteroid Injection (BMAC)

Primary Purpose

Osteoarthritis of the Knee

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Autologous bone marrow aspirate concentrate (BMAC)
Corticosteroid injections
Crossover Autologous bone marrow aspirate concentrate (BMAC)
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Osteoarthritis of the Knee

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rush University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

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

Corticosteroid injection

Crossover Group

Arm Description

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.

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

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).

Outcomes

Primary Outcome Measures

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.
Intermittent and Constant Osteoarthritis Pain (ICOAP)
13 items survey that assess two forms of pain reported by people with osteoarthritis: intermittent and constant pain.
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)

Secondary Outcome Measures

Full Information

First Posted
August 2, 2023
Last Updated
August 2, 2023
Sponsor
Rush University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05985785
Brief Title
Bone Marrow Aspirate Concentrate (BMAC) vs Corticosteroid Injection
Acronym
BMAC
Official Title
Bone Marrow Aspirate Concentrate vs Corticosteroid Injection for Symptomatic Osteoarthritis (OA) of the Knee: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 19, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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)).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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)).
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Autologous (from subject to self) bone marrow aspirate concentrate (BMAC) injections
Arm Type
Experimental
Arm Description
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.
Arm Title
Corticosteroid injection
Arm Type
Active Comparator
Arm Description
Corticosteroid injection group (ARM 2) will receive a sham incision.
Arm Title
Crossover Group
Arm Type
Other
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Autologous bone marrow aspirate concentrate (BMAC)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Corticosteroid injections
Intervention Description
Current standard of treatment for OA of the knee is corticosteroid injection.
Intervention Type
Other
Intervention Name(s)
Crossover Autologous bone marrow aspirate concentrate (BMAC)
Intervention Description
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 Information:
Title
Visual analogue scale (VAS) for pain
Description
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.
Time Frame
Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)
Title
Intermittent and Constant Osteoarthritis Pain (ICOAP)
Description
13 items survey that assess two forms of pain reported by people with osteoarthritis: intermittent and constant pain.
Time Frame
Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
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)
Time Frame
Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carla M. Edwards, PhD
Phone
312-563-5735
Email
carla_edwards@rush.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jorge Chahla, MD
Phone
(312) 432-2818
Email
jorge.chahla@rushortho.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Chahla, MD
Organizational Affiliation
Rush University Medical Center Associate Professor and Surgeon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carla M Edwards, PhD
Phone
312-563-5735
Email
carla_edwards@rush.edu
First Name & Middle Initial & Last Name & Degree
Jorge Chahla, MD, PhD
First Name & Middle Initial & Last Name & Degree
Adam Yanke, MD

12. IPD Sharing Statement

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Bone Marrow Aspirate Concentrate (BMAC) vs Corticosteroid Injection

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