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Updated: Jun 30, 2026

Porcine Liver Transplantation Without Veno-Venous Bypass As an Extended Criteria Donor Model
Published on: August 17, 2022
Porcine endogenous retroviruses and xenotransplantation
1Division of Cellular and Gene Therapies, Gene Transfer and Immunogenicity Branch, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, MD 20892, USA. Carolyn.wilson@fda.hhs.gov
Abstract:
Xenotransplantation is defined by the PHS as any procedure that involves the transplantation, implantation or infusion into a human recipient of either (a) live cells, tissues or organs from a nonhuman animal source, or (b) human body fluids, cells, tissues or organs that have had ex vivo contact with live nonhuman animal cells, tissues or organs (Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation). Use of pigs for human xenotransplantation raises concerns about the risks of transfer of infectious agents from the pig cells to xenotransplantation recipients. The observation that the porcine germline harbors genetic loci encoding porcine endogenous retroviruses (PERVs) that are in some cases infectious for human cells has resulted in renewed scientific interest in PERVs. However, in spite of the past 10 years of investigation, the actual risk for PERV infection, replication, and pathogenic outcome in human recipients of xenotransplantation products is still undefined. (Part of a multi-author review).

