Osteoarthritis of the KneeBMACNCT05985785
Bone Marrow Aspirate Concentrate (BMAC) vs Corticosteroid Injection
A study testing Autologous bone marrow aspirate concentrate (BMAC), Corticosteroid injections and Crossover Autologous bone marrow aspirate concentrate (BMAC) in people with Osteoarthritis of the Knee, run by Rush University Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Autologous bone marrow aspirate concentrate (BMAC), Corticosteroid injections and Crossover Autologous bone marrow aspirate concentrate (BMAC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2022to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Systemic diseases (Diabetes, malignancies, infections, etc.)
- Post-traumatic arthritis
- Patient had intra-articular injection on affected knee in last three months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Carla M Edwards, PhD, 312-563-5735, carla_edwards@rush.edu
Jorge Chahla, MD, PhD
About this study
Official title: Bone Marrow Aspirate Concentrate vs Corticosteroid Injection for Symptomatic Osteoarthritis (OA) of the Knee: A Randomized Controlled Trial
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.
Read the 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)).
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Autologous bone marrow aspirate concentrate (BMAC), Corticosteroid injections, Crossover Autologous bone marrow aspirate concentrate (BMAC)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 injectionsDrug
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Autologous bone marrow aspirate concentrate (BMAC) |
| Corticosteroid injection | Active comparator | Corticosteroid injection group (ARM 2) will receive a sham incision. Receives: 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). Receives: Other: Crossover Autologous bone marrow aspirate concentrate (BMAC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Measured: Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start19 Jul 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jorge Chahla, MD, Principal investigator, Rush University Medical Center Associate Professor and Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985785
- Sponsor's protocol ID
- 21052504
- Acronym
- BMAC
- Status last verified
- Aug 2026
- First submitted
- 2 Aug 2023
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Marrow Aspirate Concentrate vs Corticosteroid Injection for Symptomatic Osteoarthritis (OA) of the Knee: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05985785
- Acronym / sponsor ID
- BMAC / 21052504
- Conditions
- Osteoarthritis of the Knee
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 19 Jul 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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)).
| Arm | Type | Receives |
|---|---|---|
| Autologous (from subject to self) bone marrow aspirate concentrate (BMAC) injections | Experimental | Other: Autologous bone marrow aspirate concentrate (BMAC)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 | Active comparator | Drug: Corticosteroid injectionsCorticosteroid injection group (ARM 2) will receive a sham incision. |
| Crossover Group | Other | Other: Crossover Autologous bone marrow aspirate concentrate (BMAC)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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Systemic diseases (Diabetes, malignancies, infections, etc.)
- Post-traumatic arthritis
- Patient had intra-articular injection on affected knee in last three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Autologous (from subject to self) bone marrow aspirate concentrate (BMAC) injections |
| Corticosteroid injectionsCurrent standard of treatment for OA of the knee is corticosteroid injection. | Drug | Corticosteroid injection |
| 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) | Other | Crossover Group |
Primary outcome
Visual analogue scale (VAS) for pain
Time frame: Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)
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)
Time frame: Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)
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)
Time frame: Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jorge Chahla, MD principal investigator
Rush University Medical Center Associate Professor and Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous bone marrow aspirate concentrate (BMAC), Corticosteroid injections and Crossover Autologous bone marrow aspirate concentrate (BMAC) in people with Osteoarthritis of the Knee, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carla M. Edwards, PhD (312-563-5735, carla_edwards@rush.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.