Selection of Pediatric Patients for the Initial Clinical Trials of Cardiac Xenotransplantation

Abstract

Since the first pediatric xenotransplantation (baboon-to-human) in 1984 by Bailey, no further pediatric xenotransplants have been performed in humans. Today, with over two decades of scientific progress in the science of xenotransplantation, investigators appear to be on the verge of optimizing genetically engineered pigs suitable for human heart transplantation. The most logical first step among infants or small children would be to utilize pig xenotransplantation as a bridge-to-transplant therapy in patient groups for which available organs are rarely available in a suitable time frame. Such a clinical experiment could be considered if consistent 6-month survival can be achieved in a genetically engineered pig-to-nonhuman primate model. The most likely initial candidates would be infants with single ventricle physiology with severe heart failure after initial palliation, isolated unstable unoperated single ventricle patients, and children with severe graft failure early post-allotransplantation.