Knee Arthritis > BMAC

BMAC vs Corticosteroids for Osteoarthritis

(BMAC Trial)

Recruiting in Palo Alto (17 mi)

Overseen By Jorge Chahla, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Rush University Medical Center

Disqualifiers: Diabetes, Malignancies, Infections, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing if BMAC injections can improve symptoms in patients with knee osteoarthritis by helping repair knee tissues and reduce inflammation. It compares BMAC to standard corticosteroid injections over several months. Bone Marrow Aspirate Concentrate (BMAC) has been studied as a regenerative therapy for knee osteoarthritis, showing promise in improving pain and functionality.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you've had an injection in the affected knee in the last three months, you cannot participate.

What data supports the effectiveness of the treatment BMAC for osteoarthritis?

Research suggests that Bone Marrow Aspirate Concentrate (BMAC) may help treat knee osteoarthritis by providing growth factors that reduce inflammation and promote healing. However, results have been mixed, and more studies are needed to determine the best methods for using BMAC effectively.

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Is BMAC safe for treating osteoarthritis?

Bone marrow aspirate concentrate (BMAC) injections have been used in studies for treating osteoarthritis, and while they show promise, more research is needed to fully understand their safety. No major safety concerns have been highlighted in the available studies, but the optimal methods for using BMAC are still being explored.

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How is the BMAC treatment different from other treatments for osteoarthritis?

BMAC (Bone Marrow Aspirate Concentrate) is unique because it involves using a patient's own bone marrow cells, which are injected into the joint to potentially help repair and regenerate tissue, unlike corticosteroid injections that mainly reduce inflammation and pain.

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Eligibility Criteria

This trial is for adults aged 18-70 with moderate knee osteoarthritis pain (KL grade 2-3) that persists despite treatments like exercise, weight loss, or painkillers. They must have a pain score of at least 4 and not have had recent knee injections. Those with post-traumatic arthritis, diabetes, cancer, infections or other systemic diseases cannot participate.

Inclusion Criteria

I have had knee pain from arthritis for a long time and treatments haven't worked.

My average pain level is 4 or more on a scale of 0-10.

I am between 18 and 70 years old.

Exclusion Criteria

I have a chronic condition like diabetes or cancer.

I have arthritis caused by a past injury.

I had a knee injection in the last 3 months.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either BMAC or corticosteroid injections

Immediate post-enrollment

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Crossover

Participants in the corticosteroid group showing no improvement may crossover to BMAC group

12 months if crossover

Participant Groups

The study compares the effects of corticosteroid injections versus bone marrow aspirate concentrate (BMAC), which is derived from the patient's own bone marrow. Participants are randomly assigned to one treatment and their reported outcomes are tracked over time.

Group I: Crossover Group Experimental Treatment 1 Intervention

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).

Group II: Autologous (from subject to self) bone marrow aspirate concentrate (BMAC) injections Experimental Treatment 1 Intervention

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.

Group III: Corticosteroid injection Active Control 1 Intervention

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

BMAC is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Bone Marrow Aspirate Concentrate for:

• Osteoarthritis
• Cartilage defects
• Tendon injuries
• Ligament injuries
• Muscle injuries
• Bone fractures

🇪🇺 Approved in European Union as Bone Marrow Aspirate Concentrate for:

• Osteoarthritis
• Cartilage defects
• Tendon injuries
• Ligament injuries
• Muscle injuries
• Bone fractures

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Rush University Medical Center Chicago, IL

Who Is Running the Clinical Trial?

Rush University Medical Center Lead Sponsor

References

1. Germany pubmed.ncbi.nlm.nih.gov

Bone marrow concentrate injections for the treatment of osteoarthritis: evidence from preclinical findings to the clinical application. [2022] To investigate the available literature on the use of bone marrow aspirate concentrate (BMAC) and summarize the current evidence supporting its potential for the injective treatment of joints affected by osteoarthritis (OA).

2. Italy pubmed.ncbi.nlm.nih.gov

Clinical and functional evaluation of bone marrow aspirate concentrate vs autologous conditioned serum in the treatment of knee osteoarthritis. [2023] The aim of this study was to compare the efficacy of a single Bone Marrow Aspirate Concentrate (BMAC) with a cycle of 4 Autologous Conditioned Serum (ACS) injections in the treatment of early-stage knee osteoarthritis (OA).

3. England pubmed.ncbi.nlm.nih.gov

Prospective double-blind randomised controlled trial protocol comparing bone marrow aspirate concentrate intra-articular injection combined with subchondral injection versus intra-articular injection alone for the treatment of symptomatic knee osteoarthritis. [2022] Subchondral and intra-articular injections of bone marrow aspirate concentrate (BMAC) showed promising results for knee osteoarthritis (OA) patients. To date, there is no evidence to demonstrate whether the combination of these treatments provides higher benefits than the intra-articular injection alone.

4. United States pubmed.ncbi.nlm.nih.gov

Short-Term Efficacy of Using a Novel Low-Volume Bone Marrow Aspiration Technique to Treat Knee Osteoarthritis: A Retrospective Cohort Study. [2022] Intra-articular bone marrow concentrate (BMC) and aspirate (BMA) injections have been used with mixed results to treat osteoarthritis (OA). Given the various aspiration and concentration methods available for preparing bone marrow, more data are needed to identify the optimal bone marrow harvesting techniques to treat OA.

5. United States pubmed.ncbi.nlm.nih.gov

Concentrated Bone Marrow Aspirate for the Treatment of Chondral Injuries and Osteoarthritis of the Knee: A Systematic Review of Outcomes. [2022] Bone marrow aspirate concentrate (BMAC) has emerged as a novel treatment for pathology of the knee. Despite containing a limited number of stem cells, BMAC serves as a source of growth factors that are thought to play an important role as a result of their anabolic and anti-inflammatory effects. To our knowledge, there is no systematic review regarding the outcomes of bone marrow aspirate concentrate used for the treatment of chondral defects and osteoarthritis of the knee.

6. Germany pubmed.ncbi.nlm.nih.gov

Bone marrow aspirate concentrate injections provide similar results versus viscosupplementation up to 24 months of follow-up in patients with symptomatic knee osteoarthritis. A randomized controlled trial. [2022] The purpose of this double-blind randomized controlled trial (RCT) was to compare clinical improvement and radiographic findings up to 2 years of follow-up of a single intra-articular injection of bone marrow aspirate concentrate (BMAC) versus hyaluronic acid (HA) for the treatment of knee osteoarthritis (OA). The hypothesis was that BMAC injection could lead to better clinical and radiographic results compared to viscosupplementation.

7. United States pubmed.ncbi.nlm.nih.gov

Bone Marrow Aspirate Concentrate for the Treatment of Knee Osteoarthritis: A Systematic Review. [2022] Bone marrow aspirate concentrate (BMAC) has emerged as a therapeutic option for symptomatic knee osteoarthritis (OA).