Arterial-Mimetic Grants Molded from Purified Proteins

DESCRIPTION (provided by applicant): The development of an alternative to the currently available synthetic vascular prosthesis is of great value. Atherosclerosis vascular disease, in the form of coronary artery and peripheral vascular disease, is the leading cause of mortality in the United States. Despite vast improvements in the field of biomaterials, a useful biocompatible material is still not available for the production of small vascular grafts largely because of blood clotting/thrombosis. To overcome this problem, Dr. David B Masters, GeI-Del Technologies, Inc., has developed a patented fabrication process that uses purified proteins, water and other biochemicals to produce biomimetic material in the shape of tubes that can mimic the wall structure of blood vessels (Gel-Del TM Vasograft). Pure collagen and elastin is mixed together to create a non-woven material without protein denaturation. This material has the capacity to act as a therapeutic delivery system to allow biochemical and pharmacological intervention of graft failure and host remodeling (e.g., heparin to prevent thrombosis; growth factors for capillary formation). Vasograft can be made into conduits of any dimension, including small to medium vascular reconstructions: coronary, femoral, renal, carotid. In vitro results show that Vasograft TM has all the necessary functional and structural characteristics to become clinically useful, that is: mechanical strength >500mmHg, weeks of non-thrombogenicity from heparin release, compliance, suture strength/ reapproximation, semipermeability, fast endothelial cell attachment/migration, >50 percent elasticity, and porosity. The principal investigator's hypothesis is that implantation of Vasograft TM in arterial circulation will result in a functional and durable vascular bioprosthesis. The biologic nature of this graft will facilitate native cellular in-growth and potential "neovessel" formation. Success in these studies will lead to development of Vasograft TM for humans. Aim: 1. To prepare and evaluate Vasograft TM for vascular reconstruction, using 2.5 mm (i.d.) and 1-2cm long Vasografts TM as small diameter arterial graft in animal studies. 2a. To evaluate the patency rates of Vasograft TM as a small diameter arterial reconstruction conduit in a pig model for 30 days. 2b. To evaluate the histological characteristics of Vasograft TM after implantation in pigs.