40 Participants Needed

Bone Marrow Aspirate for ACL Injuries

Recruiting at 1 trial location
Dd
Overseen ByDaniel de la Huerta, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

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.12345

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.14678

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.13479

Who Is on the Research Team?

MO

Miguel Otero, PhD

Principal Investigator

Hospital for Special Surgery, New York

Are You a Good Fit for This Trial?

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 either male or female.
See 1 more

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.
See 5 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Investigational ArmExperimental Treatment2 Interventions
Group II: Control ArmPlacebo Group2 Interventions

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

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Bone Marrow Aspirate Concentrate for:

Find a Clinic Near You

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+

Published Research Related to This Trial

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.
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.
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.
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]

Citations

Stem Cell-Infused Anterior Cruciate Ligament Reconstruction. [2020]
Bone Marrow Aspirate Concentrate Augmentation May Accelerate Allograft Ligamentization in Anterior Cruciate Ligament Reconstruction: A Double-Blinded Randomized Controlled Trial. [2023]
Symptomatic anterior cruciate ligament tears treated with percutaneous injection of autologous bone marrow concentrate and platelet products: a non-controlled registry study. [2019]
Clinical and functional evaluation of bone marrow aspirate concentrate vs autologous conditioned serum in the treatment of knee osteoarthritis. [2023]
Clinical application of concentrated bone marrow aspirate in orthopaedics: A systematic review. [2020]
Short-Term Efficacy of Using a Novel Low-Volume Bone Marrow Aspiration Technique to Treat Knee Osteoarthritis: A Retrospective Cohort Study. [2022]
Effectiveness of a single intra-articular bone marrow aspirate concentrate (BMAC) injection in patients with grade 3 and 4 knee osteoarthritis. [2022]
Anterior cruciate ligament tears treated with percutaneous injection of autologous bone marrow nucleated cells: a case series. [2020]
Evaluation of the Consistency and Composition of Commercially Available Bone Marrow Aspirate Concentrate Systems. [2022]
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