THE NEED FOR PATENT SMALL DIAMETER VASCULAR GRAFTS IS IMMEDIATE.

THE NEED FOR PATENT SMALL DIAMETER VASCULAR GRAFTS IS IMMEDIATE. AT PRESENT THERE IS NO FDA-APPROVED SMALL VESSEL GRAFT OF 5MM OR SMALLER; SMALL DIAMETER (58MM) GRAFTS CURRENTLY IN USE (DACRON, EXPANDED POLYTETRAFLUOROETHYLENE (PTFE) TEFLON, AUTOLOGOUS SAPHENOUS VEIN, UMBILICAL VEIN BIOGRAFT) GENERALLY PERFORM POORLY. HYALURONIC ACID IS A NATURAL BIOPOLYMER AND AN UBIQUITOUS GLYCOSAMINOGLYCAN COMPONENT OF THE INTERCELLULAR MATRIX. THE EXTRAORDINARY TISSUE COMPATIBILITY OF SOLUBLE HYALURONIC ACID IS WELL DOCUMENTED. IN PHASE I OF THIS PROPOSED PROGRAM, INSOLUBLE HYALURONIC ACID COATINGS WILL BE STUDIED IN ORDER TO DETERMINE THEIR EFFECTIVENESS AS BIOLOGICAL INTERFACES WHICH ARE NONTHROMBOGENIC AND WHICH PROMOTE NORMAL HEALING (ENDOTHELIALIZATION). EXTENSIVE IN VITRO ENDOTHELIALIZATION TESTS IN TISSUE CULTURE INDICATE THAT, FOLLOWING TREATMENT WITH HYALURONIC ACID-CONTAINING MATERIAL, SYNTHETIC BIOMEDICAL POLYMERS, WHICH ORDINARILY WOULD NOT SUPPORT CELL GROWTH, NOW HAVE THE ABILITY TO PROMOTE APPARENTLY NORMAL ENDOTHELIAL CELL ATTACHMENT AND PROLIFERATION. RESULTS FROM PRELIMINARY IN VITRO TESTS OF BLOOD COMPATIBILITY (PARTIAL THROMBOPLASTIN TIMES, FACTOR XII ACTIVATION) STRONGLY SUGGEST THAT HYALURONIC ACID IS A SUPERIOR BLOOD COMPATIBLE MATERIAL. IN THESE TESTS, HYALURONIC ACID WAS COMPARED WITH OTHER WIDELY USED BLOOD CONTACTING MATERIALS. THE OBJECTIVE OF THIS PHASE I PROGRAM IS TO DEMONSTRATE MORE COMPLETELY THE UNIQUE BIOLOGICAL COMPATIBILITY OF HYALURONIC ACID AND ITS POTENTIAL FOR USE IN A SMALL DIAMETER VASCULAR GRAFT.