The Present Status of Xenotransplantation and its Potential Role in the Treatment of End-Stage Cardiac and Pulmonary Diseases

Report of the Xenotransplantation Advisory Committee of the ISHLT

Published 1 December 2000

D.K.C. Cooper, MD; A.M. Keogh, MD; J. Brink; P.A. Corris; W. Klepetko, MD; R.N. Pierson III, MD; M. Schmoeckel, MD; R. Shirakura, MD; L. Warner Stevenson, MD

J Heart Lung Transplant. 2000 Dec;19(12):1125-65

  • Advanced Heart Failure & Transplantation
  • Advanced Lung Failure & Transplantation
  • Cardiology
  • Cardiothoracic Surgery
  • Consensus Document
  • Publications & Journals
  • Pulmonology
  • Research & Immunology
  • Standards & Guidelines

An urgent and steadily increasing need exists worldwide for a greater supply of donor thoracic organs. Xenotransplantation offers the possibility of an unlimited supply of hearts and lungs that could be available electively when required. However, antibody-mediated mechanisms cause the rejection of pig organs transplanted into non-human primates, and these mechanisms provide major immunologic barriers that have not yet been overcome.

In August 1999, ISHLT established a Xenotransplantation Advisory Committee to develop a paper on the the present status of xenotransplantation (XTx) and its potential role in the future of treating patients with end-stage cardiac and pulmonary diseases. The committee was made up of members from a wide geographic background and diverse professional interest to consider the topic in a global context.

Members considered the need for a new source of thoracic organs for transplantation; the potential of XTx to fulfill this need in comparison with other therapeutic modalities; the immune barriers and potential complications of clinical XTx; as well as some of its ethical, regulatory, and financial aspects. They also considered the results believed to be necessary in experimental models before progression to a clinical trial should be undertaken, the criteria for patient selection for the initial clinical trials, and the results necessary in the clinical trials to further pursue this field of therapy. The group also assessed whether the state of the science was adequate at this stage to initiate a clinical trial, what regulatory mechanisms would be advisable to oversee such a trial, and who or what body should financially support such a trial.

This document presents a number of conclusions from the ISHLT Xenotransplantation Advisory Committee on the current status of xenotransplantation with regard to thoracic organs, and provides recommendations relating to eventual clinical trials.

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