Pediatric Cardiac Xenotransplantation and Expanded Access: Ethical Considerations

Authors

Daniel J Hurst, Rowan University
Christopher Bobier, Central Michigan University
Anthony Merlocco, University of Tennessee Health Science Center
Luz A Padilla, University of Alabama, Birmingham
Daniel Rodger, London South Bank University
David Cleveland, Children's Hospital of Los Angeles
John D Cleveland, Children's Hospital of Los Angeles

Document Type

Article

Version Deposited

None (link only)

Publication Date

10-16-2024

Publication Title

Pediatric Transplantation

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.

Recommended Citation

Hurst, Daniel J; Bobier, Christopher; Merlocco, Anthony; Padilla, Luz A; Rodger, Daniel; Cleveland, David; and Cleveland, John D, "Pediatric Cardiac Xenotransplantation and Expanded Access: Ethical Considerations" (2024). Rowan-Virtua School of Osteopathic Medicine Departmental Research. 250.
https://rdw.rowan.edu/som_facpub/250

Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial-No Derivative Works 4.0 International License.

Published Citation

Hurst DJ, Bobier C, Merlocco A, Padilla LA, Rodger D, Cleveland D, Cleveland JD. Pediatric Cardiac Xenotransplantation and Expanded Access: Ethical Considerations. Pediatr Transplant. 2024 Nov;28(7):e14876. doi: 10.1111/petr.14876. PMID: 39412392.