PHS Guideline on Infectious Disease Issues in Xenotransplantation

Abstract

Definition of Xenotransplantation and Xenotransplantation Product. The definition of "xenotransplantation" has been revised from that used in the Draft Guideline. For the purposes of this document and US PHS policy xenotransplantation is now defined to include 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. Furthermore, xenotransplantation products have been defined to include live cells, tissues or organs used in xenotransplantation. The term xenograft, used in previous PHS documents, will no longer be used to refer to all xenotransplantation products.Secretary's Advisory Committee on Xenotransplantation. Xenotransplantation research brings to the fore certain challenges in assessing the potential impact of science on society as a whole, including the role of the public in those assessments. The broad spectrum of public opinions expressed since the publication of the Draft Guideline indicates that there is neither uniform public endorsement nor rejection of xenotransplantation. The fields of research involved are rapidly moving ones, at the leading edge of medical science. Furthermore, in many instances the clinical trials are privately funded and the public may not even be aware of them. However, public awareness and understanding of xenotransplantation is vital because the potential infectious disease risks posed by xenotransplantation extend beyond the individual patient to the public at large. In addition to these safety issues, a variety of individuals and groups have identified and/or raised concerns about issues such as animal welfare, human rights, community interest and consent, social equity in access to novel biotechnologies, and allocation of human allografts versus xenotransplantation products. For all of these reasons, public discourse on xenotransplantation research is critical and necessary