Safety Evaluation Of MAPC/EPC Tissue Engineered Venous Coduit With Valve

It is accepted generally that the transplantation of autologous vein valve is the final treatment for patients suffered from the primary valve insufficiency, post-thrombotic venous valve damage and congenital vein valve defect. However, the limited source, insufficient strength of transplanted venous valve, and mismatch between the donor and host is still challenges in this field. The tissue engineered vein valve with biological activity and without immunogenicity is an idea approach to treat the primary valve insufficiency. Our previous studies in vivo showed that the engineered venous valve has a potential as a replacement for autologous venous valve transplantation. However, the safety evaluation is critical issue for translating tissue engineered vein valve into clinic application.In accordance of ISO100993-biological evaluation of medical devices, the heterogeneous decellularized venous conduit with valve, as well as the tissue engineered venous valve created by seeding autologous MAPCs and EPCs onto decelluarized scaffold were evaluated in this study including cytotoxicity assay in vitro, blood compatibility test, tests for local effects after implantation, test for immunogenicity...