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.
Is the treatment Concentrated Bone Marrow Aspirate Injection promising for ACL injuries?Yes, Concentrated Bone Marrow Aspirate Injection is promising for ACL injuries because it contains special cells and growth factors that can help repair and improve knee function. It has been increasingly used in orthopedic treatments and has shown potential benefits in studies.12356
What safety data exists for bone marrow aspirate treatments for ACL injuries?The research provided does not directly address the safety data for bone marrow aspirate treatments specifically for ACL injuries. However, it does mention the use of bone marrow aspirate concentrate (BMAC) in orthopaedic settings, including ACL reconstruction and osteoarthritis treatment. The studies focus on the efficacy and potential benefits of BMAC, but specific safety data for ACL injuries is not detailed in the abstracts provided.24589
Do I have to stop taking my current medications for the trial?Yes, you must stop taking certain medications. Specifically, you cannot use duloxetine, doxycycline, indomethacin, glucosamine, or chondroitin within 2 months before the trial. Also, you cannot have had oral or intra-articular corticosteroid injections within 3 months or hyaluronic acid or PRP injections within 6 months.
What data supports the idea that Bone Marrow Aspirate for ACL Injuries is an effective treatment?The available research shows that Bone Marrow Aspirate Concentrate (BMAC) may help improve outcomes in ACL injuries. One study found that using BMAC in ACL reconstruction could speed up the healing process of the ligament. Another study suggested that BMAC, when combined with platelet products, showed promise in treating ACL tears. While these studies indicate potential benefits, more research is needed to fully understand its effectiveness compared to other treatments.23578
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.Treatment Details
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Investigational ArmExperimental Treatment2 Interventions
Patients undergoing revision anterior cruciate ligament reconstruction surgery will get an intraoperative injection of concentrated bone marrow aspirate (cBMA).
Group II: Control ArmPlacebo Group2 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
Find a clinic near you
Research locations nearbySelect from list below to view details:
Hospital for Special SurgeryNew York, NY
Emory Orthopaedics & Spine CenterAtlanta, GA
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Who is running the clinical trial?
Hospital for Special Surgery, New YorkLead Sponsor
Arthritis FoundationCollaborator
Emory UniversityCollaborator
References
Anterior cruciate ligament tears treated with percutaneous injection of autologous bone marrow nucleated cells: a case series. [2020]This was a prospective case series designed to investigate treatment for anterior cruciate ligament (ACL) tears using an injection of autologous bone marrow concentrate.
Clinical application of concentrated bone marrow aspirate in orthopaedics: A systematic review. [2020]To examine the evidence behind the use of concentrated bone marrow aspirate (cBMA) in cartilage, bone, and tendon repair; establish proof of concept for the use of cBMA in these biologic environments; and provide the level and quality of evidence substantiating the use of cBMA in the clinical setting.
Symptomatic anterior cruciate ligament tears treated with percutaneous injection of autologous bone marrow concentrate and platelet products: a non-controlled registry study. [2019]Bone marrow concentrate (BMC) has shown promise in the treatment of several orthopedic conditions. This registry study investigated the use of autologous BMC and platelet products for percutaneous anterior cruciate ligament (ACL) treatment.
Effectiveness of a single intra-articular bone marrow aspirate concentrate (BMAC) injection in patients with grade 3 and 4 knee osteoarthritis. [2022]To evaluate the clinical efficacy and safety of an intra-articular injection of bone marrow aspirate concentrate (BMAC) as a treatment option for osteoarthritis (OA) of the knee.
Stem Cell-Infused Anterior Cruciate Ligament Reconstruction. [2020]Anterior cruciate ligament (ACL) tears are unfortunate but common injuries in the athletic population. The standard of care for ACL tears is a surgical intervention to reconstruct the ACL to restore knee functionality as well as quality of life. In recent years, bone marrow aspirate concentrate (BMAC) has seen increasing use in various orthopaedic settings. This increase can be attributed to the potential beneficial qualities that mesenchymal stem cells, progenitor cells, and growth factors, all of which are present in BMAC, can provide. In this technical note and accompanying video, we describe an anatomic allograft ACL reconstruction infused with BMAC to utilize BMAC's potential benefits.
Evaluation of the Consistency and Composition of Commercially Available Bone Marrow Aspirate Concentrate Systems. [2022]Bone marrow aspirate (BMA) concentrate (BMAC) has gained popularity as a treatment modality for various orthopaedic conditions; however, there are still inconsistencies in its reported therapeutic efficacy. This may be because of the many different commercial BMAC preparation systems used clinically, which generate dissimilar concentrate products.
Bone Marrow Aspirate Concentrate Augmentation May Accelerate Allograft Ligamentization in Anterior Cruciate Ligament Reconstruction: A Double-Blinded Randomized Controlled Trial. [2023]To assess the effect of bone marrow aspiration concentrate (BMAC) augmentation on clinical outcomes and magnetic resonance imaging (MRI) findings in anterior cruciate ligament (ACL) reconstruction (ACLR) with bone-patellar tendon-bone (BTB) allografts.
Clinical and functional evaluation of bone marrow aspirate concentrate vs autologous conditioned serum in the treatment of knee osteoarthritis. [2023]The aim of this study was to compare the efficacy of a single Bone Marrow Aspirate Concentrate (BMAC) with a cycle of 4 Autologous Conditioned Serum (ACS) injections in the treatment of early-stage knee osteoarthritis (OA).
Short-Term Efficacy of Using a Novel Low-Volume Bone Marrow Aspiration Technique to Treat Knee Osteoarthritis: A Retrospective Cohort Study. [2022]Intra-articular bone marrow concentrate (BMC) and aspirate (BMA) injections have been used with mixed results to treat osteoarthritis (OA). Given the various aspiration and concentration methods available for preparing bone marrow, more data are needed to identify the optimal bone marrow harvesting techniques to treat OA.