A RESORBABLE COLLAGEN PROSTHESES FOR REPAIR

THE CENTRAL PURPOSE OF THIS RESEARCH IS TO TEST THE EFFICACY OF A COLLAGEN-BASED TUBULAR PROSTHESIS TO PROMOTE AXONAL REGENERATION IN THE PERIPHERAL NERVOUS SYSTEM IN VIVO. THE PROSTHESIS IS NONTOXIC AND BIODEGRADABLE AND IS FABRICATED FROM NATURAL CONNECTIVE-TISSUE COMPONENTS. DURING PHASE I, AMERICAN BIOMATERIALS CORPORATION WILL CONTINUE STUDIES IN RODENTS, WHILE PHASE II WILL CONCENTRATEON NONHUMAN PRIMATES AND POTENTIAL HUMAN CLINICAL TRIALS. USING BOTH ANATOMIC AND PHYSIOLOGIC TECHNIQUES, AMERICAN BIOMATERIALS CORPORATION WILL QUANTIFY AND DIRECTLY COMPARE CURRENT STANDARD NERVE-REPAIR PROCEDURES WITH THE NEW PROPOSED TUBULAR PROSTHESIS. THE FIRST SPECIFIC AIM WILL FOCUS ON THE PRODUCTION AND QUALITY-CONTROL TESTING OF COLLAGEN-BASED NERVE GUIDES. OTHER SPECIFIC AIMS WILL INVOLVE BIOLOGICAL TESTING OF THE NERVE GUIDES AND A CRITICAL COMPARISON OF PERIPHERAL NERVE REPAIR USING STANDARD CLINICAL NERVE MICROSUTURE AND GRAFTING PROCEDURES VERSUS ENTUBULATION REPAIR WITH THE COLLAGEN-BASED PROSTHESIS. SUCH QUANTITATIVE COMPARISONS HAVE DIRECT CLINICAL RELEVANCE TO HUMAN PERIPHERAL NERVE REPAIR.