CRYOPRESERVATION OF VENOUS AND ARTERIAL TISSUE

CURRENTLY IN THE UNITED STATES THERE ARE 360,000 SMALL VESSEL IMPLANTS AND 100,000 PERIPHERAL VASCULAR RECONSTRUCTIONS ANNUALLY. OF THIS POPULATION NEEDING VASCULAR SURGERY, APPROXIMATELY 15 PERCENT OF THE PATIENTS DO NOT HAVE VESSELS SUITABLE FOR AUTOGRAFTS. A PROTOTYPE PROCEDURE HAS BEEN DEVELOPED FOR THE CRYOGENIC PRESERVATION OF ARTERIES AND VEINS WITH AN INTACT ENDOTHELIAL LINING FOR TRANSPLANTATION. THIS PROPOSAL IS FOR COMPLETION OF THE DEVELOPMENT OF CRYOGENIC TECHNOLOGY ALONG WITH ANCILLARY SURGICAL AND TRANSPORT METHODOLOGIES TO ENABLE THE COMMERCIALIZATION OF ARTERIAL AND VENOUS HOMOGRAFTS FOR THE MEDICAL COMMUNITY. IN PHASE I, OPTIMIZATION OF THE CRYOBIOLOGICAL PROCEDURES AND TESTING OF THE EFFICACY OF VESSELS STORED IN THIS TECHNOLOGY WILL BE PERFORMED IN A CANINE MODEL SYSTEM. EFFICACY OF THE PRESERVATION WILL BE JUDGED BY THE INTEGRITY OF THE ENDOTHELIUM USING MORPHOLOGICAL CRITERIA, PATENCY, FACTOR VIII STAINING, ADHESION OF RADIO-LABELED PLATELETS, IN VITRO PROLIFERATIVE CAPACITY, AND PROSTACYCLIN PRODUCTION.