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

Trial Summary

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.

What data supports the effectiveness of the treatment Bone Marrow Aspirate (BMA) for knee injuries?

Research shows that Bone Marrow Aspirate (BMA) can significantly reduce knee pain in patients with severe osteoarthritis, with more than 50% pain reduction observed in a case study. Additionally, BMA contains growth factors that may help repair knee injuries by reducing inflammation and promoting healing. ^{1 2 3 4 5}

Is bone marrow aspirate safe for treating knee injuries?

In a study involving patients with severe knee osteoarthritis treated with bone marrow aspirate, no adverse events were reported, suggesting it is generally safe for use in humans. ^{1 2 6 7 8}

How is Bone Marrow Aspirate treatment different from other treatments for knee injuries?

Bone Marrow Aspirate (BMA) treatment is unique because it uses a patient's own cells, specifically mesenchymal stem cells and growth factors, to potentially reduce inflammation and promote healing in knee injuries. Unlike traditional treatments, BMA involves injecting these cells directly into the knee, which may offer significant pain relief and improved function for those with severe knee osteoarthritis. ^{1 2 4 5 7}

What is the purpose of this trial?

This study will examine whether using bone marrow aspirate (BMA) during knee arthroscopy surgery can improve patient outcomes. The investigators will enroll 50 patients who need knee arthroscopy surgery for meniscus injuries or cartilage damage. Like flipping a coin, patients will be randomly assigned to one of two groups of 25 patients each. One group will receive standard arthroscopic surgery plus an injection of bone marrow aspirate, while the other group will receive standard surgery plus a saline (salt water) injection. During surgery, for patients in the treatment group, approximately 4mL (less than one teaspoon) of bone marrow will be taken from their hip bone using a special needle system. A small amount (1mL) will be sent to the laboratory for testing. Patients will be followed for 12 months after surgery and will complete questionnaires about their pain levels and knee function at several time points: before surgery, 2 weeks, 6 weeks, 3 months, 6 months, and 12 months after surgery. These questionnaires will ask about pain, daily activities, and overall improvement.

Research Team

Anil S Ranawat, MD

Principal Investigator

Hospital for Special Surgery, New York

Eligibility Criteria

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 have not used any OrthoBiologics within 6 months before surgery.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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) 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) 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]

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]

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]

References

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

High Variability of Mesenchymal Stem Cells Obtained via Bone Marrow Aspirate Concentrate Compared With Traditional Bone Marrow Aspiration Technique. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Short-term outcomes after pure bone marrow aspirate injection for severe knee osteoarthritis: a case series. [2021]

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

Quantitative T2 MRI Mapping and 12-Month Follow-up in a Randomized, Blinded, Placebo Controlled Trial of Bone Marrow Aspiration and Concentration for Osteoarthritis of the Knees. [2022]

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

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

A single step, centrifuge-free method to harvest bone marrow highly concentrated in mesenchymal stem cells: results of a pilot trial. [2022]

7. 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]

8. 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]