in vivo Evaluation of a Tissue Blood Vessel

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DESCRIPTION (provided by applicant): Coronary heart disease is the leading cause of death in the industrialized world. Despite advances in catheter-based interventions, bypass remains the treatment with the greatest long-term efficacy. The primary limitation of this approach is the availability of native vessels. Researchers have investigated synthetic grafts, cell seeded synthetics, and decellularized tissues as alternates to native grafts. These alternative vascular conduits are limited by early thrombosis and/or aneurysm. We have developed a completely autologous human tissue engineered blood vessel (TEBV) with a functional endothelium and burst pressures 20-fold physiological blood pressure. Since the vessel is completely autologous, we do not expect immune reaction and subsequent degradation. We have completed our Phase I objectives of automating key steps in the fabrication of these TEBVs and we have biomechanically characterized TEBVs built from cells harvested from humans with advanced vascular disease. We have xenografted these human vessels into canines and rats (14 and 90 day patency respectively) to successfully demonstrate short-term mechanical strength and anti-thrombogenicity. In Phase II, we will: . Evaluate efficacy in an animal model,Optimize compliance and strength of the human TEBVs, . Study diffusion and optimize strength per unit thickness . Integrate the bioreactor modules