Pre-clinical in vivo testing of GMP tissue-engineered small calibre arterial vessels and heart valves

(Prof. Dr. Augustinus Bader, Cell Techniques and Applied Stem Cell Biology, Biomedical Biotechnical Centre (BBZ), Leipzig; Email:Augustinus.Bader@bbz.uni-leipzig.de

The aim of the project is to investigate the safety and efficiency of tissue engineered small calibre vascular grafts and heart valves based on acellularised xenogenic starter matrices in a clinically relevant and regulatory approved large animal in vivo model. Regulatory considerations require that the in vivo trials are performed under standardised and reproducible conditions. The following steps were taken: (a) the standardisation of acquisition of biological material from the donor and preparation thereof; (b) the reseeding of the matrix structure with endothelial cells and myofibroblasts. The next step is (c); the investigation of the biocompatibility of the reseeded matrix structure in vivo.