Commercialization of a Tissue Engineered Blood Vessel

描述(由申请人提供)：该PA规定的目标是资助临床前和临床测试，以支持对前景看好的医疗技术的监管要求。因此，这笔赠款的目标是执行FDA定义的过程验证测试和体内实验，以支持Lifeline(Tm)血管移植物的商业化。这种组织工程化移植物完全是生物的和自体的，并解决了与合成移植物相关的基本失败机制。LifeLine(Tm)作为冠状动脉和外周搭桥以及血液透析患者的动静脉通路的天然动脉/静脉的替代方案，在临床上前景看好。根据透析结果质量倡议，完成本提案中列出的目标将支持Lifeline(Tm)移植物的商业化，即迫切需要替代ePTFE护理标准的患者群体。

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.