Expert opinion on the identification, risk assessment, and mitigation of microorganisms and parasites relevant to xenotransplantation products from pigs

Huybert Groenendaal, Solenne Costard, Reid Ballard, Stephen Bienhoff, Diana C. Challen, Brandon J. Dominguez, Douglas R. Kern, Dan Miller, Jeske Noordergraaf, Larisa Rudenko, Henk Jan Schuurman, Tom Spizzo, Matthew Sturos, Bill Zollers, Jay A. Fishman

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

Xenotransplantation has the potential to address shortages of organs available for clinical transplantation, but concerns exist regarding potential risks posed by porcine microorganisms and parasites (MP) to the health of human recipients. In this study, a risk-based framework was developed, and expert opinion was elicited to evaluate porcine MP based on swine exposure and risk to human health. Experts identified 255 MP to include in the risk assessment. These were rated by experts for five criteria regarding potential swine exposure in the USA and human health risks. MP were subsequently categorized into three risk mitigation groups according to pre-defined rules: disqualifying porcine MP (due to their pathogenic potential, n = 130); non-disqualifying porcine MP (still relevant to consider for biosecurity or monitoring efforts, n = 40); and alert/watch list (not reported in the USA or MP not in swine, n = 85). Most disqualifying (n = 126) and non-disqualifying (n = 36) porcine MP can effectively be eliminated with high biosecurity programs. This approach supports surveillance and risk mitigation strategies for porcine MP in swine produced for xenotransplantation, such as documentation of freedom from porcine MP, or use of porcine MP screening, monitoring, or elimination options. To the authors’ knowledge, this is the first effort to comprehensively identify all relevant porcine MP systematically and transparently evaluate the risk of infection of both donor animals and immunosuppressed human recipients, and the potential health impacts for immunosuppressed human recipients from infected xenotransplantation products from pigs.

Original languageEnglish (US)
Article numbere12815
JournalXenotransplantation
Volume30
Issue number5
DOIs
StatePublished - Sep 1 2023

Bibliographical note

Publisher Copyright:
© 2023 BioPolicy Solutions, LLC. EpiX Analytics. et al and The Authors. Xenotransplantation published by John Wiley & Sons Ltd.

Keywords

  • hazard identification
  • human health
  • pig
  • porcine microorganisms
  • porcine parasites
  • risk assessment
  • risk management
  • xenotransplantation

PubMed: MeSH publication types

  • Journal Article

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