Tissue-engineered heart valves (TEHV) have the potential to revolutionize valve replacements therapies, especially for pediatric patients. While much progress has been made toward implanting a TEHV, a major limitation to date has been in vivo leaflet retraction due to the contractile nature of the cells transplanted within the TEHV. This phenomenon has been problematic in numerous studies, particularly for approaches employing the use of a fibrin scaffold (Syedain et al. 2011, Flanagan et al. 2009). Additional challenges in the development of a TEHV include designing a 3D mold that allows for proper coaptation and functionality of engineered leaflets. Herein, we present a novel approach for developing a TEHV from a decellularized engineered tube fabricated from fibrin that is remodeled by entrapped dermal fibroblasts, and matured using a custom pulse flow-stretch bioreactor. This approach has the potential to deliver an off-the-shelf engineered heart valve that exhibits the ability to be readily recellularized in contrast to current clinically employed tissue-based valve replacements.

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