The stated objective for this PA is to fund pre-clinical and clinical tests to support regulatory requirements for promising medical technologies. Accordingly, the objective of this grant is to perform process validation tests and in vivo experiments defined by the FDA to support commercialization of the Lifeline(tm) vascular graft. This tissue engineered graft is completely biological and autologous, and addresses the fundamental failure mechanisms associated with synthetic grafts. Lifeline(tm) demonstrates promise as a clinically viable alternative to native artery/vein for coronary and peripheral bypass as well as A-V access for hemodialysis patients. Completion of the Aims listed in this proposal will support commercialization of the Lifeline(tm) graft for a patient population that is, according to the Dialysis Outcome Quality Initiative, in desperate need of an alternative to the ePTFE standard of care.
|Peck, Marissa; Gebhart, David; Dusserre, Nathalie et al. (2012) The evolution of vascular tissue engineering and current state of the art. Cells Tissues Organs 195:144-58|
|Konig, Gerhardt; McAllister, Todd N; Dusserre, Nathalie et al. (2009) Mechanical properties of completely autologous human tissue engineered blood vessels compared to human saphenous vein and mammary artery. Biomaterials 30:1542-50|
|L'Heureux, Nicolas; Dusserre, Nathalie; Konig, Gerhardt et al. (2006) Human tissue-engineered blood vessels for adult arterial revascularization. Nat Med 12:361-5|