Commercialization of a Tissue Engineered Blood Vessel

描述（由申请人提供）：本PA的既定目标是资助临床前和临床试验，以支持有前景的医疗技术的监管要求。因此，该资助的目的是进行FDA规定的工艺验证试验和体内实验，以支持Lifeline（TM）血管移植物的商业化。这种组织工程移植物是完全生物和自体的，并解决了与合成移植物相关的基本失效机制。Lifeline（TM）显示出作为自体动脉/静脉的临床可行替代品的前景，用于冠状动脉和外周旁路以及血液透析患者的A-V通路。 完成本提案中列出的目标将支持Lifeline（tm）移植物的商业化，用于根据透析结果质量倡议急需ePTFE标准治疗替代品的患者人群。

DESCRIPTION (provided by applicant): 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.