PRIMATE MODEL EVALUATION OF A TISSUE ENGINEERED HEART VALVE

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This translational research project is prompted by the need to develop new evaluative tools to assess the preclinical safety of tissue engineered biological heart valves intended for use in infants, children and young adults. Chronic in vivo studies in sheep may not be sufficient to adequately evaluate primate-specific complex biology, immune and inflammatory-mediated responses that are critical factors expected to significantly impact the safety, performance and therapeutic durability of a tissue engineered biological heart valve for human clinical use. Such a tissue engineered cardiovascular construct, by definition, includes both cells (derived from the patient/recipient), and structural proteins (derived from the donor heart valve). The putative prototypical tissue engineered pulmonary valved conduit scaffold to be tested consists of either an allograft (homograft; ie, baboon species for orthotopic transplant) or a xenograft (human semilunar valve) scaffold. Both test valve types will have been engineered to effect removal of donor cells and reduce antigenicity (using our novel decellularization process). This design will test the safety of the acellular construct and the immunogenic and proinflammatory potential of allograft (papio) versus xenograft (human) structural proteins.