Pediatric Cardiac Xenotransplantation and Expanded Access: Ethical Considerations

• Published in: Pediatric transplantation 2024-11, Vol.28 (7), p.e14876-n/a
• Main Authors: Hurst, Daniel J., Bobier, Christopher, Merlocco, Anthony, Padilla, Luz A., Rodger, Daniel, Cleveland, David, Cleveland, John D.
• Format: Article
• Language: English
• Subjects: Allografts; Animals; Animals, Genetically Modified; cardiac; Child; ethics; expanded access; Health Services Accessibility - ethics; Heart transplantation; Heart Transplantation - ethics; Humans; Infant; Infant, Newborn; Informed Consent; Kidney transplantation; Neonates; pediatric; Pediatrics; Population genetics; Swine; Tissue and Organ Procurement - ethics; Transplantation, Heterologous - ethics; United States; United States Food and Drug Administration; Waiting Lists; Xenografts; xenotransplantation
• ISSN: 1397-3142; 1399-3046; 1399-3046
• DOI: 10.1111/petr.14876

ABSTRACT Due to the current organ shortage waitlist, alternatives to allotransplantation are necessary. Xenotransplantation is currently being pursued as one such alternative in adults in need of kidney or heart transplantation. Cardiac xenotransplantation of genetically modified pig hearts has been conducted twice in adults under the United States Food and Drug Administration (FDA) expanded access criteria. Because of the shortage of transplantable hearts for children as well as the lack of mechanical circulatory support in this population, pediatric researchers are exploring FDA expanded access in high‐risk neonates and infants who lack alternative options for survival. The adult cardiac xenotransplantation experience with expanded access can provide lessons and highlight nuances for researchers preparing pediatric application. This includes aspects of informed consent, biosurveillance, and protection of bystanders from potential xenozoonoses.