Ethical and regulatory issues concerning engineered tissues for congenital heart repair

Recent progress in the fields of tissue engineering and xenotransplantation has brought the reality of using engineered tissues for the treatment of congenital heart disease ever closer. However, the introduction of complex scientific advances into the clinic can generate difficult ethical dilemmas for surgeons, patients, and the wider public. Conventional regulatory approaches are not well suited to the introduction of novel cell- and tissue-based therapies. This review presents a short summary of the current state of the art of tissue engineering and xenotransplantation as it relates to congenital heart surgery. The ethical arguments and emerging regulatory framework are then presented, with emphasis on the regulation of tissue-engineered heart valves and the ethics of cardiac xenotransplantation.