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Abstract

Grant Number: 5R44HL064462-06
Project Title: Commercialization of a Tissue Engineered Blood Vessel
PI Information:NameEmailTitle
L'HEUREUX, NICOLAS nico@cytograft.com CHIEF SCIENTIFIC OFFICER

Abstract: 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.

Thesaurus Terms:
biomaterial development /preparation, biomaterial evaluation, blood vessel, tissue engineering
biological model, hyperplasia, physiologic anastomosis, thrombosis, vascular endothelium
Macaca fascicularis, biotechnology, clinical research, human subject, patient oriented research

Institution: CYTOGRAFT TISSUE ENGINEERING, INC.
NOVATO, CA 94949
Fiscal Year: 2007
Department:
Project Start: 15-MAY-2000
Project End: 31-JUL-2008
ICD: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
IRG: ZRG1


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