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Infectious disease risks in xenotransplantation.

Jay A Fishman1

  • 1Infectious Disease Division and MGH Transplant Center, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.

American Journal of Transplantation : Official Journal of the American Society of Transplantation and the American Society of Transplant Surgeons
|March 8, 2018
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Clinical xenotransplantation faces infectious risks, but screening and pathogen-free pigs mitigate swine-to-human pathogen transmission. These infectious risks are manageable for safe clinical trials.

Keywords:
clinical research/practiceclinical trialcomplication: infectiousethicsinfection and infectious agentsinfection and infectious agents - viralinfectious diseasetranslational research/sciencexenotransplantation

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Area of Science:

  • Xenotransplantation
  • Infectious Disease Risk Assessment
  • Microbiology

Background:

  • Clinical xenotransplantation faces hurdles, primarily the risk of infectious disease transmission from animals to humans.
  • Swine (pigs) are a common source for xenografts, and potential zoonotic pathogens must be rigorously evaluated.
  • Intensive immunosuppression required for xenograft recipients can amplify infectious risks.

Purpose of the Study:

  • To investigate and evaluate the infectious risks associated with clinical xenotransplantation.
  • To assess the safety of upcoming clinical xenotransplantation trials regarding pathogen transmission.
  • To identify and characterize potential infectious agents transmissible from swine to humans.

Main Methods:

  • Review of existing data on swine pathogens, including porcine cytomegalovirus (PCMV), porcine lymphotropic herpesvirus (PLHV), and porcine endogenous retrovirus (PERV).
  • Evaluation of screening strategies, such as "designated pathogen free" breeding colonies and microbiological assays (antibody-based, molecular assays).
  • Assessment of the impact of immunosuppression on infectious risk in xenograft recipients.

Main Results:

  • Porcine herpesviruses (PCMV, PLHV) are generally species-specific and do not infect human cells.
  • Human cellular receptors exist for PERV, but human infection has not been documented; PERV-inactivated pigs are now available.
  • Screening paradigms and diagnostic assays can effectively identify and exclude potential human pathogens.

Conclusions:

  • Significant progress has been made in evaluating infectious risks for xenotransplantation.
  • Available data suggest that the risks of recipient infection are manageable, allowing for safe clinical trials.
  • Potential infectious risks to the wider community remain undefined and require further consideration.