Biohybrid Material With Extracellular Matrix Core and Polymeric Coating as a Cell Honing Cardiovascular Material

Objective: To characterize the safety and efficacy of a hybrid composite material for cardiovascular applications. Background: Cardiovascular tissue substitutes that resorb and become host like tissues, are needed, especially for children undergoing congenital cardiac surgery. In this work, we report a biohybrid material consisting of a native extracellular matrix core, and engulfed in a thin layer of cell-honing, degradable, polymer, to achieve host integration of the implanted material. Methods and Results: Decellularized bovine pericardial extracellular matrix was used as the core, with 70µm thick nanofiber matrix of polycaprolactone-chitosan electrospun onto it. Spectroscopy of the cross-section depicted new amide chemical bond formation and C-O-C stretch at the interface. Mechanical strength and extensibility ratio of the matrix alone was 18,000±4200 KPa, and 0.18+0.03 %, whereas the composite was 20,000±6600 KPa, 0.35+0.20% indicating an increase in strength as well as extensibility. In 46 rats implanted with the material subcutaneously, cellular infiltration into the material core was significantly higher in the biohybrid, compared to the core alone or other alternatives. In 3 juvenile sheep the material was non-thrombogenic, with good cellular infiltration and remodeling, when used as a left atrial, carotid, and a pulmonary artery patch. Conclusions: The feasibility of a new biohybrid material is demonstrated, with the potential to hone host cells and remodel into a native tissue like structure.