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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments for knee osteoarthritis: BMAC, where bone marrow cells are injected back into the knee, and corticosteroid injections. The goal is to determine which treatment better improves symptoms like pain and mobility, based on patient reports. Individuals with long-term knee pain from osteoarthritis who haven't found relief with standard treatments might be suitable candidates. As an unphased trial, this study offers a unique opportunity to explore innovative treatments that could provide relief where traditional methods have failed.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that bone marrow aspirate concentrate (BMAC) is generally safe for people. Studies have found that BMAC can reduce pain and improve movement in those with osteoarthritis. These studies, which included follow-ups over several years, reported no major safety issues.

Corticosteroid injections, a well-known treatment with a long history of use, are usually safe. However, they can sometimes cause side effects like temporary pain at the injection site or a rise in blood sugar levels.

In summary, both BMAC and corticosteroid injections have been studied for safety. BMAC is a promising new treatment, while corticosteroid injections are already familiar and widely used. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike standard osteoarthritis treatments like NSAIDs, physical therapy, or hyaluronic acid injections, BMAC (Bone Marrow Aspirate Concentrate) injections offer a novel approach by using the patient's own cells to potentially regenerate damaged joint tissues. Researchers are excited about BMAC because it involves a unique mechanism where the concentrated cells, drawn from the patient's bone marrow, are injected back into the knee, possibly promoting natural healing and reducing inflammation. This autologous method not only minimizes the risk of rejection but also holds promise for long-term relief and improved joint function, making it an innovative alternative to traditional corticosteroid injections.

What evidence suggests that this trial's treatments could be effective for osteoarthritis?

This trial will compare BMAC (Bone Marrow Aspirate Concentrate) injections with corticosteroid injections for knee osteoarthritis. Research has shown that BMAC injections can help with this condition. In one study, patients experienced significant improvements in knee function and pain over four years, as measured by specific health scores. Another study with 231 patients also reported positive results using BMAC for knee osteoarthritis. These findings suggest that BMAC might help reduce pain and improve joint function for those with this condition. In contrast, corticosteroid injections, which participants in this trial may receive, are often used to reduce inflammation and pain but may not offer long-term relief. ^{2 4 6 7 8}

Who Is on the Research Team?

Jorge Chahla, MD

Principal Investigator

Rush University Medical Center Associate Professor and Surgeon

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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) 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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38929594/

Effectiveness and Complications of Bone Marrow Aspirate ... This study retrospectively evaluated data from 231 patients (285 knees) with knee OA treated with BMAC articular injection at a single center ...

2. nature.com nature.com/articles/s41598-024-51410-2

Intra-articular injection of bone marrow aspirate ... This is the first study on BMAC injections into 37 osteoarthritic knees with a 4-year follow up showing significant improvements in IKDC and WOMAC scores.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04716803

Bone Marrow Aspirate Concentrate (BMAC)Treatment for ... This is a pilot open-label, non-randomized, single institution study of BMAC administration in patient's with moderate to severe osteoarthritis of the knee who ...

4. mdpi.com mdpi.com/1648-9144/61/5/853

Bone Marrow Aspirate Concentrate (BMAC) for Knee ... [23] in patients with severe knee OA (Kellgren-Lawrence grade III–IV) demonstrated substantial and sustained improvements in IKDC (from 56 ± 12 to 73 ± 13, p < ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749806324000938

Meta-Analysis Platelet-Rich Plasma, Bone Marrow Aspirate ... At a minimum 6-month follow-up, PRP demonstrated significantly improved pain and function for patients with knee osteoarthritis compared to placebo.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11208346/

Safety and Efficacy of Bone-Marrow Aspirate Concentrate ... The results from this review demonstrated that administration of BMAC is safe and potentially efficacious in terms of reducing pain, improving function and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12113016/

Bone Marrow Aspirate Concentrate (BMAC) for Knee ... Bone marrow aspirate concentrate (BMAC) is an emerging regenerative therapy for OA. Unlike traditional intra-articular injections, such as hyaluronic acid (HA) ...

8. link.springer.com link.springer.com/article/10.1007/s43465-024-01183-7

Safety and Efficacy of Bone-Marrow Aspirate Concentrate ... The results from this review demonstrated that administration of BMAC is safe and potentially efficacious in terms of reducing pain, improving function and ...