Pediatric Cardiac Xenotransplantation and Expanded Access: Ethical Considerations

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...

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Bibliographic Details
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
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Summary: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.
ISSN:1397-3142
1399-3046
1399-3046
DOI:10.1111/petr.14876