Development of Novel Biodegradable Scaffold for Non-Cell-Seeding In-vivo Tissue-Engineering Vasculature for Clinical Applications

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We have developed a new biodegradable scaffold that does not require any cell preparation steps before its implantation to create an in-situ tissue-engineering vasculature (iTEV). Animal experiments were conducted to test its characteristics and long-term efficacy in a venous and a pulmonary positions. Eight to 10-millimeter tubular-shaped biodegradable scaffolds which consist of polyglycolide knitted fiber and L-lactide and -caprolactone copolymer sponge with outer glycolide and e-caprolactone copolymer monofilament reinforcement were implanted into canine inferior vena cava (IVC) and left pulmonary artery. All canines were well alive until each experiment, and the utility of the iTEV was evaluated from 1 to 24 months according to the studies. Histological studies and angiographies revealed well formed iTEV without marked stenosis/thrombosis or calcifications. These results provide direct evidence that this new scaffold can be useful for cell free tissue-engineering of vasculature.