Bone Marrow Aspirate for Knee Injuries

(BMA Trial)

Overseen By Akshay K Raghuram

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Hospital for Special Surgery, New York

Must not be taking: DMARDs, Steroids

Disqualifiers: Prior knee surgery, Anemia, others

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

Compensation: Varies

Number of Visits: 7

Duration: 1 day

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding bone marrow aspirate (BMA) during knee surgery can enhance recovery from meniscus injuries or cartilage damage. Participants will receive either standard knee surgery with a BMA injection or standard surgery with a saline (salt water) injection. The study will monitor patients' knee function and comfort over the next year. Individuals needing knee surgery for a meniscus tear or cartilage issue, who have not undergone prior knee surgeries, might be suitable candidates for this study. As an unphased trial, it offers patients the chance to contribute to innovative research that could improve future knee surgery outcomes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used DMARDs (disease-modifying antirheumatic drugs) in the last three months or have had a prior steroid injection.

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

Research has shown that using bone marrow aspirate (BMA) for knee treatments is generally safe. Taken from the patient's own body, BMA is well-tolerated, with most patients experiencing few issues. One study found only a small number of complications when BMA was used for knee osteoarthritis. Because BMA is autologous, meaning it comes from the patient, it usually lowers the risk of side effects. Overall, BMA is accepted as a safe option for knee problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatment for knee injuries, which typically involves arthroscopic debridement surgery to clean out damaged tissue, the investigational approach in this trial includes injecting bone marrow aspirate (BMA) alongside the surgery. BMA is special because it contains stem cells and growth factors that might help speed up healing and tissue regeneration. Researchers are excited about this because it could potentially enhance recovery and improve joint function more effectively than surgery alone. This combination could offer a promising new way to treat knee injuries, giving patients a better chance at a faster and more complete recovery.

What evidence suggests that bone marrow aspirate might be an effective treatment for knee injuries?

Research has shown that bone marrow aspirate (BMA) can improve knee function and reduce pain. One study found that patients experienced significant improvement in their knee condition for up to four years after receiving BMA injections. Another study reported reliable and effective results for patients with knee osteoarthritis treated with BMA. In this trial, one group will receive arthroscopic debridement surgery combined with BMA, while another group will receive the surgery with a saline injection. BMA appears to aid in repairing cartilage, potentially helping with knee injuries like meniscus tears or cartilage damage. While more research is needed, early findings suggest BMA could be a promising addition to knee surgery. ^{1 2 3 5 6}

Who Is on the Research Team?

Anil S Ranawat, MD

Principal Investigator

Hospital for Special Surgery, New York

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-55 with mild knee arthritis or cartilage damage who need primary knee arthroscopy. Candidates should not have had previous knee surgery, metabolic bone diseases, recent OrthoBiologics treatments, ligament deficiencies, severe arthritis, anemia, bleeding disorders or inflammatory joint disease.

Inclusion Criteria

My arthritis is at the earliest stage according to Kellgren-Lawrence grading.

Have Outerbridge cartilage grade 2 or lower

I need knee surgery for a torn meniscus or cartilage damage.

Exclusion Criteria

I have had surgery on the same knee before.

I have a history of bone disease such as osteoporosis or Paget's disease.

I need surgery to fix my knee's meniscus.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo arthroscopic debridement surgery with either bone marrow aspirate or saline injection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment through questionnaires and objective tests

12 months

6 visits (in-person or virtual) at baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Bone Marrow Aspirate (BMA)

Trial Overview

The study tests if injecting Bone Marrow Aspirate (BMA) during knee arthroscopy improves outcomes compared to a saline injection. Participants are randomly divided into two groups: one receives BMA and the other saline alongside standard surgery. They're monitored for a year post-surgery.

How Is the Trial Designed?

Group I: Arthroscopic Debridement Surgery + Bone Marrow Aspirate (BMA) Experimental Treatment 2 Interventions

Arthroscopic debridement surgery is standard of care to treat the conditions that are within the inclusion criteria of the study. The study investigates the effect of combining the standard of care with a bone marrow aspirate (BMA), therefore this serves as the Active Experimental arm.

Group II: Arthroscopic Debridement Surgery + Saline Active Control 2 Interventions

Arthroscopic debridement surgery is standard of care to treat the conditions that are within the inclusion criteria of the study, therefore it serves as an Active Comparator to the experimental arm which is the same procedure but with the addition of bone marrow aspirate (BMA) injection.

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials

257

Recruited

61,800+

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]

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 (BMA) contains a higher concentration of mesenchymal stem cells (MSCs) and more colony-forming units (CFUs) compared to bone marrow aspirate concentrate (BMAC), indicating that BMA may be more effective for cell-based therapies.

BMAC failed to concentrate MSCs in 6 out of 8 samples tested, highlighting significant variability in MSC quantity and potency between BMA and BMAC, which raises concerns about the reliability of BMAC for clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High Variability of Mesenchymal Stem Cells Obtained via Bone Marrow Aspirate Concentrate Compared With Traditional Bone Marrow Aspiration Technique. Brozovich, A., Sinicrope, BJ., Bauza, G., 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]

Citations

1.

pubmed.ncbi.nlm.nih.gov

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

Effectiveness and Complications of Bone Marrow Aspirate ...

This study aimed to identify the effectiveness and potential complications on the harvest site and knee of bone marrow aspirate concentrate ...

2.

nature.com

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

Intra-articular injection of bone marrow aspirate ...

Pre- and postoperative results show significant improvement up to year 4 in both scores.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11206007/

Effectiveness and Complications of Bone Marrow Aspirate ...

This study showed that BMAC treatment in patients with K–L grades II–III knee OA provides reliable and effective clinical outcomes over a 6- ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2773157X25002486

Repairing Knee Cartilage with Hyalofast: A Systematic ...

When combined with Hyalofast, microfracture and bone marrow aspirate concentrate achieve comparable improvements in functional and pain outcomes ...

5.

aaos.org

aaos.org/globalassets/quality-and-practice-resources/biologics/technology-overview-concentrated-bone-marrow-aspirate-for-knee-osteoarthritis.pdf

Concentrated Bone Marrow Aspirate for Knee Osteoarthritis

Basic science studies have shown promising results with increased anabolic function of cartilage with limited high quality randomized clinical ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06311513

Concentrated Bone Marrow Aspirate in Revision ACL ...

The primary outcome measured for this study will be postoperative knee pain. This will be achieved using the Knee Injury and Osteoarthritis Outcome Score (KOOS) ...