BMAC vs Corticosteroids for Osteoarthritis

(BMAC Trial)

Overseen By Jorge Chahla, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Diabetes, Malignancies, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate post-enrollment

100 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

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. ^{1 2 3 4 7}

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.

Research Team

Jorge Chahla, MD

Principal Investigator

Rush University Medical Center Associate Professor and Surgeon

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.

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.

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

Treatment Details

Interventions

• BMAC
• Corticosteroid Injection

Trial Overview 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.

Participant Groups

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

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Findings from Research

Bone marrow aspirate concentrate (BMAC) injections show promise for treating osteoarthritis (OA), with 22 studies involving 4626 patients indicating overall safety and low adverse events.

Most studies reported improvements in pain and function, but significant variability in study quality and methodology suggests that more rigorous, large-scale trials are needed to confirm BMAC's effectiveness in OA treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone marrow concentrate injections for the treatment of osteoarthritis: evidence from preclinical findings to the clinical application. Cavallo, C., Boffa, A., Andriolo, L., et al.[2022]

A single injection of Bone Marrow Aspirate Concentrate (BMAC) significantly improved knee osteoarthritis symptoms, showing better results in pain and function compared to a cycle of 4 Autologous Conditioned Serum (ACS) injections over a six-month follow-up.

Both BMAC and ACS treatments were found to be safe and effective, but BMAC demonstrated greater efficacy in reducing pain and improving function as measured by the WOMAC index.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and functional evaluation of bone marrow aspirate concentrate vs autologous conditioned serum in the treatment of knee osteoarthritis. Vitali, M., Ometti, M., Pironti, P., et al.[2023]

A study involving 86 patients with knee osteoarthritis is investigating whether combining subchondral and intra-articular injections of bone marrow aspirate concentrate (BMAC) leads to greater improvements in knee pain and function compared to intra-articular injections alone.

The primary outcome will be measured using the Western Ontario and McMaster Universities Osteoarthritis Index, with additional assessments at 12 months, providing a comprehensive evaluation of the treatment's efficacy.

NCBI (Pubmed)

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. Silva, S., Andriolo, L., Boffa, A., et al.[2022]

Intra-articular injections of low-volume bone marrow aspirate harvested using the Marrow Cellution™ device significantly reduced pain in knee osteoarthritis patients, with VAS scores improving from 7.29 to 3.76 over six months (p < 0.0001).

A substantial 71% of patients showed improvements in VAS scores that surpassed the minimal clinically important difference, indicating that this treatment is not only effective but also leads to meaningful pain relief and improved function in daily activities.

NCBI (Pubmed)

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. Kuebler, D., Schnee, A., Moore, L., et al.[2022]

Bone marrow aspirate concentrate (BMAC) shows promising efficacy in treating chondral defects and osteoarthritis of the knee, with all studies reporting good to excellent outcomes.

The procedure is considered safe, but the review highlights a lack of high-quality studies, indicating a need for more rigorous research to confirm these findings.

NCBI (Pubmed)

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. Chahla, J., Dean, CS., Moatshe, G., et al.[2022]

In a study involving 60 patients with knee osteoarthritis, a single injection of bone marrow aspirate concentrate (BMAC) showed more durable clinical improvements over 24 months compared to hyaluronic acid (HA), particularly in patients with mild OA.

Both treatments were safe, with no severe adverse events reported, and similar rates of mild adverse events and treatment failures, indicating that BMAC is a viable alternative to HA for knee OA management.

NCBI (Pubmed)

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. Boffa, A., Di Martino, A., Andriolo, L., et al.[2022]

Bone marrow aspirate concentrate (BMAC) injections significantly improve pain and patient-reported outcomes in knee osteoarthritis, with 94.4% of outcomes showing improvement over a mean follow-up of 12.9 months across 299 knees.

Despite its effectiveness, BMAC did not show clinical superiority over other treatments like platelet-rich plasma or microfragmented adipose tissue, and its high cost may limit its use compared to other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone Marrow Aspirate Concentrate for the Treatment of Knee Osteoarthritis: A Systematic Review. Keeling, LE., Belk, JW., Kraeutler, MJ., et al.[2022]

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]

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]

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]

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]

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]

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]

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

Bone Marrow Aspirate Concentrate for the Treatment of Knee Osteoarthritis: A Systematic Review. [2022]