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

Launched by RUSH UNIVERSITY MEDICAL CENTER · Dec 1, 2020

Keywords

ClinConnect Summary

Introduction

Anterior cruciate ligament (ACL) tears are a common and devastating injury among young athletes, and re-injury poses significant threats to both successful return to play and long term outcomes. Graft healing during ACL reconstruction (ACLR) is a slow biologic process, that involves graft incorporation into bone tunnel sites, as well as intra-articular graft remodeling . The intra-articular graft remodeling process is known as ligamentization, and occurs in three phases after ACLR. The first phase of early healing occurs between 0 and three months, the second phase occurs betw...

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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