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Biologic Augmentation for ACL Reconstruction

This study is looking at whether adding Mesenchymal Stem Cells (special cells from your own bone marrow) can help heal and integrate the graft used in Anterior Cruciate Ligament (ACL) reconstruction surgery. You might be able to join if you are between 18 and 60 years old, speak English, and are having ACL reconstruction for a recent injury (within 6 months) using a patellar tendon allograft (tissue from a donor). Researchers will measure how well the graft is healing and integrating using MRI scans at 9 months after surgery. They will also look at your reported outcomes and how well your knee functions. The current status of this study is unclear, and it plans to enroll 100 participants.

Study design
This is an interventional study planning to enroll 100 participants. It compares injecting Mesenchymal Stem Cells into the ACL graft to a sham procedure (a small incision where bone marrow would have been taken).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 9 months, suggesting follow-up for at least that long after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04650568

Biologic Augmentation With Mesenchymal Stem Cells in Patients Undergoing Anterior Cruciate Ligament Reconstruction

Enrolling by Invitation
NAAges 18–60InterventionalTreatment
Rush University Medical Center
~100 participants
Updated 2026-06-18 on ClinicalTrials.gov
What's tested:Autologous Bone Marrow Derived Mesenchymal Stem CellsSham incision

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Signal to Noise Quotient
Measured over 9 months

Conditions

Anterior Cruciate Ligament Injury
Anterior Cruciate Ligament Rupture

Explore related trials

Injury of anterior cruciate ligament

NCT04650568

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Rush University Medical Center

    Chicago, Illinoisno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

English-speaking patients
18-60 years of age with acute ACL injury (\<6 months from time of injury to reconstruction) and undergoing reconstruction with patellar tendon allograft
Written informed consent is obtained

Exclusion

Revision Surgery
Prior history of knee surgery
Concomitant ligamentous injury
Inability to obtain an MRI
Inability to participate in follow-up for the study
Any patient lacking decisional capability
Diagnosed musculoskeletal cancer or any diagnosed cancer, other than
musculoskeletal if not on long term remission (e.g. at least 5 years or negative biopsy at last exam), except basal cell carcinoma
Patients who are at higher risk for post-surgical bleeding (e.g., bleeding disorder taking anticoagulants except low dose aspirin) or post-surgical infection (e.g., taking immunosuppressants; have a severe infection or a history of serious infection or use of systemic steroids)
Known history of HIV, or has active Hepatitis B or active Hepatitis C
Alcohol and drug (medication) abuse
Pregnant or breast feeding women. Pregnancy as determined by a positive pregnancy test prior to procedure. Females of childbearing potential must agree to use an acceptable birth control method during study participation.
Patients that have received PRP, other platelet-based product, or investigational treatment in another cell/biologic study for the target knee in the 12 months prior to the injection procedure
Any clinically significant finding that would place the patient at health risk, impact the study, or affect the completion of the study
Any psychiatric illness that would prevent comprehension of the details and nature of the study and interfere with follow-up clinic visits

What this trial measures

  • Signal to Noise Quotient9 months

    Signal intensity of the ACL graft on T2 weighted MRI imaging compared to a reference structures' signal intensity