Commercialization of a Tissue Engineered Blood Vessel

组织工程血管的商业化

• 批准号: 6933467
• 负责人: Nicolas L'Heureux
• 金额: $ 85.19万
• 依托单位: CYTOGRAFT TISSUE ENGINEERING, INC.
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-05-15 至 2008-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6933467
• 关键词: Macaca fascicularis; biological models; biomaterial development /preparation; biomaterial evaluation; biotechnology; blood vessels; clinical research; human subject; hyperplasia; patient oriented research; physiologic anastomosis; thrombosis; tissue engineering; vascular endothelium

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.

描述（由申请人提供）：此PA的既定目标是为临床前和临床测试提供资金，以支持有前途的医疗技术的监管要求。因此，该赠款的目的是进行过程验证测试和FDA定义的体内实验，以支持生命线（TM）血管移植的商业化。该组织工程移植物完全生物学和自体，并解决了与合成移植物相关的基本故障机制。生命线（TM）证明了有望是冠状动脉和外围旁路的天然动脉/静脉的临床可行替代品，以及血液透析患者的A-V进入。 根据透析结果质量倡议，本提案中列出的目标的完成将支持生命线（TM）移植物的商业化（TM），这是迫切需要替代EPTFE护理标准的替代品。