There is a major clinical need for products to repair articular cartilage defects. The objective of this project is to develop a chondral repair device for articular cartilage that can be formed in vivo, and adheres to the surrounding host articular cartilage. The project uses two recently developed and complementary technologies that together have the potential to provide a mechanically functional and stable implant for articular cartilage repair. The intent of this Phase I project is to determine the feasibility of this product concept. The hypothesis for this proposal is that a composite construct with mechanical properties similar to native articular cartilage can be formed, adhered to native cartilage and provide an in situ articular chondral repair. To test the hypothesis three Specific Aims are proposed.
Specific Aim 1. Optimize the composite construct to compressive and tensile properties of native human adult articular cartilage. Component variables will be assessed in a factorial study, to determine the optimal combination of biomaterials that provide tensile and compressive properties similar to native articular cartilage.
Specific Aim 2. Optimize adherence of the composite construct to articular cartilage.
Specific Aim 3. Demonstrate formation and attachment of the device in situ. The conditions identified in Aims 1 and 2 will be used to determine if the composite construct can be assembled within an articular defect in situ. The successful completion of this Phase I project will lead to a Phase II project, where the objective will be to determine safety and effectiveness of the device and method in vivo, using appropriate animal models. If successful, the data generated from these studies will be used in an IDE submission to the FDA to initiate a clinical trial. ? ? ?
