Abstract
Prosthetic materials currently used in pediatric cardiovascular surgery such as expanded polytetrafluoroethylene （ePTFE）, lack growth potential and are prone to thrombosis and infection. We developed a novel tissue-engineered vascular graft （TEVG） using a biodegradable scaffold seeded with bone marrow mononuclear cells. By use of the TEVG, vascular neotissue forms and, a living, biocompatible conduit was created as the scaffold degraded. We performed a pilot clinical study in Japan in 2001 using TEVG as a conduit for extracardiac total cavopulmonary connections in patients with single ventricle cardiac anomalies. Twenty-five TEVGs were implanted with ten-year follow up. The TEVGs were shown to function well without evidence of aneurysmal change or calcification. No graft had to be replaced and there was no graft related mortality. Four patients required catheter intervention for the stenosis. We started a clinical trial under Food and Drug Administration （FDA） approval in the United States in 2011. To develop the second generation of the TEVG, extensive laboratory research is underway to figure out the mechanism of vascular tissue formation and stenosis formation using various genetically engineered mouse models.
