State of the art and science for clinical translation of regenerative cardiac surgery

Cardiac surgery is entering a new era in which complex tissue reconstructions will be performed with bioengineered and tissue engineered constructs that reflect current discoveries in regenerative tissue methodologies. Cells of appropriate phenotype will be restored in well-designed functioning scaffolds using various methodologies including directed cell homing and seeding with pluripotent cells. Small children will benefit as hypoplastic vessels can be reconstructed with growth capable replacements obviating multiple reoperations. There has been a major need for pediatric heart valves that will allometrically grow and remodel synchronously with patient, somatic growth, this may be realized utilizing such technologies. The focus in this issue of Progress in Pediatric Cardiology is the clinical translation needed for the achievement of a tissue engineered heart valve. The numerous potential barriers are reviewed including scientific, surgical, logistical, regulatory challenges. Tissue engineered constructs will straddle the traditional definition of devices (the scaffold component) and biologics (the restored cell population component) and thus, may be defined as combination products. The central role of intellectual property in translational research may require different models of institutional research infrastructure and funding. Pediatric academic medical centers are adapting to these new realities, and instituting research programs, laboratories and collaborative science teams to tackle development of new regenerative surgical methodologies.