Bone Marrow Aspirate for ACL Injuries

Recruiting at 1 trial location

Overseen By Daniel de la Huerta, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Hospital for Special Surgery, New York

Must not be taking: Corticosteroids, Hyaluronic acid, PRP, others

Disqualifiers: Inflammatory arthritis, Joint sepsis, Avascular necrosis, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

Duration: Intraoperative

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this pilot randomized clinical trial is to look into the efficacy of concentrated bone marrow aspirate (cBMA) in improving post traumatic osteoarthritis (PTOA) symptoms in patients undergoing revision anterior cruciate ligament reconstruction surgery. The main questions it aims to answer are whether clinical outcomes, such as pain, are improved in patients who get cBMA with surgery, if there is a change in circulating markers of inflammation and what part of the cellular and molecular composition of cBMA may explain its effects.

Will I have to stop taking my current medications?

The trial requires that you stop using certain medications like duloxetine, doxycycline, indomethacin, glucosamine, and chondroitin at least 2 months before participating. If you are using oral or injected corticosteroids, you must stop 3 months prior, and for hyaluronic acid or PRP injections, you must stop 6 months before.

What data supports the effectiveness of the treatment Concentrated Bone Marrow Aspirate Injection for ACL injuries?

Research suggests that bone marrow aspirate concentrate (BMAC) may help improve outcomes in ACL reconstruction by providing beneficial cells and growth factors. Studies have shown that BMAC can accelerate the healing process in ACL surgeries and has been promising in treating other orthopedic conditions. ^{1 2 3 4 5}

Is bone marrow aspirate concentrate (BMAC) safe for use in humans?

Research indicates that bone marrow aspirate concentrate (BMAC) has been used in various orthopedic treatments, including knee osteoarthritis, with studies evaluating its safety. While specific safety data for ACL injuries is limited, BMAC has been generally considered safe in other orthopedic applications. ^{1 4 5 6 7}

How is the treatment with concentrated bone marrow aspirate injection different from other treatments for ACL injuries?

Concentrated bone marrow aspirate injection (BMAC) is unique because it uses a patient's own bone marrow cells, which contain stem cells and growth factors, to potentially aid in healing ACL injuries. Unlike traditional surgical reconstruction, BMAC is a less invasive option that involves injecting these concentrated cells directly into the injury site to promote tissue repair. ^{1 3 5 8 9}

Research Team

Miguel Otero, PhD

Principal Investigator

Hospital for Special Surgery, New York

Eligibility Criteria

This trial is for individuals who have had a previous ACL (Anterior Cruciate Ligament) reconstruction and are now in need of a revision surgery. They should be experiencing symptoms related to post-traumatic osteoarthritis. Specific eligibility criteria details were not provided.

Inclusion Criteria

I had ACL surgery in the past 5 years and it didn't work as expected.

I am scheduled for a repeat ACL surgery using any graft type.

I am between 18 and 55 years old.

Exclusion Criteria

I have had inflammatory arthritis or an infection in my joint.

I have not taken oral steroids or had a steroid injection in the last 3 months.

I do not have any severe health issues that could make the trial unsafe for me.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo revision ACL reconstruction surgery with either cBMA injection or sham incision

Intraoperative

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at multiple time points

24 months

Multiple visits (in-person and virtual) at 6 weeks, 6 months, 12 months, and 24 months

Biological Specimen Collection

Collection and analysis of biological specimens (blood, urine, synovial fluid) to evaluate inflammatory markers

Up to 24 months

Specimen collection at baseline, 6 weeks, and 12 months

Treatment Details

Interventions

• Concentrated Bone Marrow Aspirate Injection

Trial Overview The study is testing the effectiveness of concentrated bone marrow aspirate (cBMA) injections during revision ACL surgery, compared to standard care with sham incision. It aims to see if cBMA can reduce pain and inflammation markers after surgery.

Participant Groups

Group I: Investigational Arm Experimental Treatment 2 Interventions

Patients undergoing revision anterior cruciate ligament reconstruction surgery will get an intraoperative injection of concentrated bone marrow aspirate (cBMA).

Group II: Control Arm Placebo Group 2 Interventions

Patients undergoing revision anterior cruciate ligament reconstruction surgery will get a sham incision in lieu of bone marrow harvesting.

Concentrated Bone Marrow Aspirate Injection is already approved in United States for the following indications:

Approved in United States as Bone Marrow Aspirate Concentrate for:

• Osteoarthritis
• Cartilage defects
• Tendinopathies
• Chronic ACL graft failure

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials

257

Recruited

61,800+

Arthritis Foundation

Collaborator

Trials

36

Recruited

46,500+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Findings from Research

Bone marrow aspirate concentrate (BMAC) is being increasingly used in ACL reconstruction surgeries due to its potential benefits from mesenchymal stem cells and growth factors.

The technique described involves infusing BMAC into an anatomic allograft ACL reconstruction, which may enhance knee functionality and improve recovery outcomes for athletes with ACL tears.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stem Cell-Infused Anterior Cruciate Ligament Reconstruction. Youn, GM., Remigio Van Gogh, AM., Alvarez, A., et al.[2020]

In a study of 80 patients undergoing ACL reconstruction, those who received bone marrow aspiration concentrate (BMAC) showed significantly improved MRI signal intensity at 3 months, indicating enhanced metabolic activity and potential for faster healing of the graft.

At 9 months post-surgery, patients with BMAC augmentation reported better knee function (IKDC scores) compared to the control group, although both groups had similar rates of achieving clinically meaningful improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone Marrow Aspirate Concentrate Augmentation May Accelerate Allograft Ligamentization in Anterior Cruciate Ligament Reconstruction: A Double-Blinded Randomized Controlled Trial. Forsythe, B., Chahla, J., Korrapati, A., et al.[2023]

In a study of 29 patients with symptomatic ACL tears, 77% showed significant improvement in ACL integrity after receiving autologous bone marrow concentrate (BMC) injections, indicating its potential as an effective non-surgical treatment option.

Patients reported an average improvement of 72% in their symptoms at around 23 months post-treatment, with significant reductions in pain and improved functional scores measured at multiple time points, suggesting long-term benefits of BMC therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptomatic anterior cruciate ligament tears treated with percutaneous injection of autologous bone marrow concentrate and platelet products: a non-controlled registry study. Centeno, C., Markle, J., Dodson, E., et al.[2019]

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]

Concentrated bone marrow aspirate (cBMA) shows significant clinical benefits in repairing cartilage, bone, and tendon injuries, with improvements in healing rates and quality of repair surfaces observed in various studies involving 36 trials.

Despite the promising results, there is considerable variability in cBMA preparation methods and outcomes across studies, highlighting the need for standardized protocols and further research to optimize its use in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical application of concentrated bone marrow aspirate in orthopaedics: A systematic review. Gianakos, AL., Sun, L., Patel, JN., et al.[2020]

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]

In a small case series of 10 patients with ACL tears, 70% showed objective improvements in ligament integrity after receiving an injection of autologous bone marrow concentrate, suggesting this treatment may enhance healing.

Patients reported significant improvements in knee function, with a mean increase of 23.3 points on the Lower Extremity Functional Scale, indicating that this treatment could be effective for managing ACL injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anterior cruciate ligament tears treated with percutaneous injection of autologous bone marrow nucleated cells: a case series. Centeno, CJ., Pitts, J., Al-Sayegh, H., et al.[2020]

The Harvest SmartPrep 3 system demonstrated greater consistency in concentrating white blood cells compared to the Arthrex Angel system, indicating it may be more reliable for certain therapeutic applications.

Different BMAC preparation systems yield varying compositions of cell types, with Harvest recovering the highest percentages of colony-forming unit-fibroblasts and CD34+ cells, while Biomet excelled in platelet recovery, suggesting that each system has unique advantages for specific treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Consistency and Composition of Commercially Available Bone Marrow Aspirate Concentrate Systems. Dragoo, JL., Guzman, RA.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Stem Cell-Infused Anterior Cruciate Ligament Reconstruction. [2020]

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

Bone Marrow Aspirate Concentrate Augmentation May Accelerate Allograft Ligamentization in Anterior Cruciate Ligament Reconstruction: A Double-Blinded Randomized Controlled Trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Symptomatic anterior cruciate ligament tears treated with percutaneous injection of autologous bone marrow concentrate and platelet products: a non-controlled registry study. [2019]

4. 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]

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

Clinical application of concentrated bone marrow aspirate in orthopaedics: A systematic review. [2020]

6. 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]

7. 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]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Anterior cruciate ligament tears treated with percutaneous injection of autologous bone marrow nucleated cells: a case series. [2020]

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

Evaluation of the Consistency and Composition of Commercially Available Bone Marrow Aspirate Concentrate Systems. [2022]