This $369,178 Project Grant award from the National Heart, Lung, and Blood Institute (NHLBI) under the Cardiovascular Diseases Research program (CFDA 93.837) supports the preclinical optimization and design for manufacturability of immunoregulatory tissue-engineered vascular grafts (TEVGs).
The University of Pittsburgh, the prime awardee, is conducting final in vitro testing and large animal validation of its silk scaffold-based TEVG constructs seeded with extracellular vesicles. This work aims to demonstrate acceptable critical quality attributes and in vivo performance over 8 weeks and 6 months when implanted as carotid artery interposition grafts in a sheep model. The project also addresses manufacturing feasibility and regulatory planning to prepare for a pre-IDE meeting with the FDA, with the goal of advancing this TEVG technology towards clinical translation.
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