From the Bench to the Clinic: Advancing Extracellular Matrix Material for Ligament Repair

Abstract

The field of orthopedic biomaterials has advanced significantly in recent years, particularly in the development of alternatives to traditional surgical approaches for ligament and tendon injuries. Our team is currently in the process of translating an extracellular matrix-based biomaterial from the bench into the clinic for first-in-human clinical trials. The two projects presented in this thesis represent a portion of the translational process in preparation for an Investigational Device Exemption (IDE) application to the Food and Drug Administration (FDA). As part of this application, we have conducted in vitro studies optimizing a variety of parameters such as composition, concentration and sterilization. In parallel, we have conducted three large animal studies to validate the efficacy and safety of our ECM-based biomaterial. The first project in this thesis investigates the composition of our material and whether the use of whole blood versus platelet rich plasma (PRP) mixed with our ECM material, stimulates ACL fibroblast growth more. The second project investigates post-sterilization treatments to mitigate potential cytotoxic effects from residual sterilants. Both projects share a common goal: to enhance the clinical translation of biologically inspired therapies that promote tissue healing and regeneration. These efforts address critical limitations in current surgical techniques and biomaterial processing methods.