BMAC for Osteoarthritis

Overseen By Adam Yanke, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Diabetes, Rheumatoid arthritis, Transplantation, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 1 day

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The proposed research study aims to evaluate the effects of autologous bone marrow aspirate concentrate (BMAC) on the development and progression of osteoarthritis (OA) in patients undergoing meniscectomy. This prospective, randomized, double-blind clinical trial will compare patient-reported outcomes, specifically IKDC scores between patients who receive BMAC post-meniscectomy and those who receive a saline control injection. The study will also compare physical examination, MRI, radiographs, and synovial fluid analysis. Our hypothesis is that those who receive the autologous BMAC injection after the procedure will have better outcomes than those who do not.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have had a cortisone, viscosupplementation, or PRP injection in the last 6 weeks, you may not be eligible to participate.

Is BMAC safe for treating osteoarthritis?

Research on BMAC for osteoarthritis suggests it is generally safe for use in humans, with studies evaluating its safety alongside its effectiveness for joint treatment. ^{1 2 3 4 5}

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

BMAC (Bone Marrow Aspirate Concentrate) is unique because it involves injecting a concentrate derived from a patient's own bone marrow into the affected joint, which provides growth factors with potential anti-inflammatory and tissue-repairing effects. Unlike other treatments, BMAC uses the body's own cells to potentially improve joint function and reduce symptoms. ^{1 2 4 6 7}

What data supports the effectiveness of the treatment Autologous Bone Marrow Aspirate Concentrate (BMAC) for osteoarthritis?

Research shows that BMAC, which is a treatment made from a patient's own bone marrow, has shown promising results in reducing symptoms of knee osteoarthritis. It contains growth factors that help reduce inflammation and promote healing in the joints. ^{1 2 4 6 7}

Who Is on the Research Team?

Brian Cole, MD

Principal Investigator

Midwest Orthopaedics at Rush

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a painful meniscal tear confirmed by MRI and surgery, who need a meniscectomy. They must have mild to moderate osteoarthritis but no history of rheumatoid arthritis, recent infections requiring antibiotics, prior knee surgeries, or injections within the last 6 weeks. Pregnant individuals or those with diabetes, transplant history, decision-making impairments, recent cancer (except basal cell), or severe osteoarthritis are excluded.

Inclusion Criteria

I am over 18 years old.

Written informed consent is obtained

I need surgery for a painful knee tear.

Exclusion Criteria

I have rheumatoid arthritis or another autoimmune disorder.

I am having or have had surgery for ligament or cartilage repair.

I currently have an infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo meniscectomy followed by either a BMAC injection or a placebo saline injection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including IKDC scores, synovial fluid analysis, and radiographic analysis

2 years

Multiple visits at 7-10 days, 6 weeks, 3 months, 6 months, 1 year, and 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Autologous Bone Marrow Aspirate Concentrate

Trial Overview The study tests if injecting Bone Marrow Aspirate Concentrate (BMAC) after meniscectomy can slow down osteoarthritis progression compared to a saline injection. It's randomized and double-blind meaning neither patients nor doctors know who gets BMAC or saline. Outcomes will be measured through patient scores on knee function (IKDC), physical exams, MRIs, X-rays and joint fluid analysis.

How Is the Trial Designed?

Group I: Meniscectomy with Bone Marrow Aspirate Concentrate (BMAC) Experimental Treatment 2 Interventions

Subjects will undergo the scheduled meniscectomy procedure. Following the procedure the investigator will make a small incision and create the marrow access channel in the proximal tibia. The experimental group will then have bone marrow harvested and BMAC will be prepared using a BMAC harvesting system. The automated centrifuge system rapidly concentrates cellular contents and growth factors in bone marrow aspirate using flow cytometry. The BMAC will be injected intra-articularly.

Group II: Meniscectomy with Placebo Placebo Group 1 Intervention

Subjects will undergo the same meniscectomy procedure and will also have an incision and marrow access channel made in the proximal tibia, however no bone marrow will be harvested. The control group will have a placebo injection of saline into the affected knee.

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Published Research Related to This Trial

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]

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]

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 of 233 patients with knee osteoarthritis, a single intra-articular injection of bone marrow aspirate concentrate (BMAC) led to significant pain reduction, with the numeric pain scale decreasing from 8.33 to 4.49 after treatment.

The procedure was found to be safe, with no complications reported, and resulted in improved knee function as indicated by an increase in the Oxford knee score from 20.20 to 32.29 over an average follow-up period of 11 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a single intra-articular bone marrow aspirate concentrate (BMAC) injection in patients with grade 3 and 4 knee osteoarthritis. Themistocleous, GS., Chloros, GD., Kyrantzoulis, IM., et al.[2022]

Intra-articular injections of bone marrow aspirate concentrate (BMC) for early knee and hip osteoarthritis showed significant improvement in patient-reported outcomes, with scores decreasing from 40.8% to 20.6% (P < .001) over an average follow-up of 13.2 months.

The treatment was deemed safe, with a satisfaction rate of 63.2%, and 64% of patients achieved the minimal clinically important difference, although two patients required total hip arthroplasty within 8 months post-injection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Clinical Outcomes of Intra-Articular Injections of Bone Marrow Aspirate Concentrate for the Treatment of Early Osteoarthritis of the Hip and Knee: A Cohort Study. Rodriguez-Fontan, F., Piuzzi, NS., Kraeutler, MJ., et al.[2022]

Citations

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

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

2. Germany pubmed.ncbi.nlm.nih.gov

Bone marrow concentrate injections for the treatment of osteoarthritis: evidence from preclinical findings to the clinical application. [2022]

3. 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]

4. 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]

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. England pubmed.ncbi.nlm.nih.gov

Effectiveness of a single intra-articular bone marrow aspirate concentrate (BMAC) injection in patients with grade 3 and 4 knee osteoarthritis. [2022]

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

Early Clinical Outcomes of Intra-Articular Injections of Bone Marrow Aspirate Concentrate for the Treatment of Early Osteoarthritis of the Hip and Knee: A Cohort Study. [2022]