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

Enrolling by invitation · Not applicable · Has a placebo group

Conditions studied: Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Rupture

In brief

This study will evaluate the efficacy of biologic augmentation of ACL reconstruction with bone marrow derived mesenchymal stem cells as measured by magnetic resonance imaging to detect graft healing and integration. Secondary endpoints will include validated patient reported outcome measures, as well as functional outcome using objective examination findings.

Key facts

Study ID

NCT04650568

Run by

Rush University Medical Center

People needed

100

Starts

2017-11-03

Expected to finish

2027-12-31

Last updated by the study team

2026-06-18

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Rush University Medical Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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