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Xenotransplantation Science, Ethics, and Public Policy (1996) / Chapter Skim
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5. Conclusions and Recommendations
Pages 92-96

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From page 92...
... Because xenotransplants involve the direct insertion of potentially infected cells, tissues, or organs into humans, there is every reason to believe that the potential for transmission of infectious agents (some of which may not even now be recognized) from animals to human transplant recipients is real.
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From page 93...
... Screening of donor tissue must be complemented with mandatory active surveillance of patients receiving xenotransplants, as well as their contacts, for the sole purpose of determining the safety of xenotransplantation. Such surveillance will require collection of tissue and serum samples and coordination of information in a central database or registry.
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From page 94...
... Therefore: Recommendation 2: The committee recommends that adherence to specific national guidelines be required of all experimenters and institutions that undertake xenotransplantation trials in humans. Local institutional review boards and animal care committees, in consultation with outside experts, are appropriate vehicles for review of proposed protocols, provided that they are required to conform to the national guidelines for minimizing and for continued surveillance of infectious risks.
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From page 95...
... In addition, the advisory committee could regularly review and advise the Department of Health and Human Services on guidelines in the light of evolving knowledge. Coordination within a single federal agency is difficult because the establishment of guidelines for xenotransplants involves addressing a broad range of questions of science, ethics, and public policy currently addressed handled a number of agencies.
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From page 96...
... Hence: Recommendation 5: The committee recommends that, when the science base for specific types of xenotransplants is judged sufficient and the appropriate safeguards are in place, wellchosen human xenotransplantation trials using animal cells, tissues, and organs would be justified and should proceed. Clinical trials with cellular xenotransplants are already under way, and a real danger exists that the commercial applications of xenotransplant technology will outstrip both the research base and the national capacity to address special issues raised by xenotransplantation, including the risk of disease transmission.
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Key Terms

  • infectious disease
  • national guidelines
  • xenotransplantation trials
  • disease transmission
  • donor tissue

  • receiving xenotransplants
  • serum samples
  • infectious agents
  • institutional review
  • patient registries

  • human xenotransplantation
  • source animals
  • local institutional
  • continued surveillance
  • review boards

  • infectious diseases
  • committee agreed
  • local irb
  • animal donor
  • patients receiving

  • outside experts
  • individual clinical
  • specific augmentation
  • clinical science
  • science base

  • maintain patient
  • tissue banks
  • pancreatic islet
  • single federal
  • animal cells


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