Xenotransplantation involves the transplantation of cells, tissues, and whole organs from one species to another. Interest in animal-to-human xenotransplants has been spurred by the continuing shortage of donated human organs and by advances in knowledge concerning the biology of organ and tissue rejection. The scientific advances and promise, however, raise complex questions that must be addressed. This book considers the scientific and medical feasibility of xenotransplantation and explores the ethical and public policy issues surrounding the possibility of renewed clinical trials. The volume focuses on the science base of xenotransplantation, public health risks of infectious disease transmission, and ethical and public policy issues, including the views of patients and their families.
Some developing biotechnologies challenge accepted legal and ethical norms because of the risks they pose. Xenotransplantation (cross-species transplantation) may prolong life but may also harm the xeno-recipient and the public due to its potential to transmit infectious diseases. These trans-boundary diseases emphasise the global nature of advances in health care and highlight the difficulties of identifying, monitoring and regulating such risks and thereby protecting individual and public health. Xenotransplantation raises questions about how uncertainty and risk are understood and accepted, and exposes tensions between private benefit and public health. Where public health is at risk, a precautionary approach informed by the harm principle supports prioritising the latter, but the issues raised by genetically engineered solid organ xenotransplants have not, as yet, been sufficiently discussed. This must occur prior to their clinical introduction because of the necessary changes to accepted norms which are needed to appropriately safeguard individual and public health.
Based on presentations, transcripts of round-table discussions and comments raised at the workshop, this book provides an overview of the field and of current regulatory frameworks and addresses the most pressing international policy considerations on xenotransplantation.
One of the leading causes of death is organ failure, and the supply of replacement parts is limited due to its dependence on donors. This volume examines the legal and ethical issues surrounding xenotransplantation and considers the implications for the future.
This title provides an illuminating examination of the current state of xenotransplantation – grafting or transplanting organs or tissues between members of different species – and how it might move forward into the clinic. To be sure, this is a critical topic, as a major problem that remains worldwide is an inadequate supply of organs from deceased human donors, severely limiting the number of organ transplants that can be performed each year. Based on presentations given at a major conference on xenotransplantation, this title includes important views from many leading experts who were invited to present their data and opinions on how xenotransplantation can advance into the clinic. Attention was concentrated on pig kidney and heart transplantation as it is in regard to these organs that most progress has been made. Collectively, these chapters effectively highlight the many advantages of xenotransplantation to patients with end-stage organ failure, thereby encouraging the mapping of a concrete pathway to clinical xenotransplantation. The book is organized across 22 chapters, beginning with background information on clinical and experimental xenotransplantation. Following this are discussions addressing how pigs can be genetically engineered for their organs to be resistant to the human immune response through deletion of pig xenoantigens, and the insertion of ‘protective’ human transgenes. Subsequent chapters analyze complications that arise in practice, comparing allotransplant and xenotransplant rejection. The selection of the ideal patients for the first clinical trials is discussed. Finally, the book concludes with an analysis on the regulatory, economic, and social aspects of this research, including FDA perspectives and the sensitive, psychosocial factors regarding allotransplantation and xenotransplantation. A major and timely addition to the literature, Clinical Xenotransplantation will be of great interest to all researchers, physicians, and academics from other disciplines with an interest in xenotransplantation.
Recently, remarkable progress has been made in the area of preclinical xenotransplantation experiments. Surprisingly, a heterotopic heart from the gene-editing pig continued to beat for almost 2.5 years, when implanted in the monkey abdomen, and a pig life-supporting kidney could also function for over 1.3 years in monkeys. Concerning islets, islets from gene-editing pigs could work for more than one year in monkeys. It is noteworthy that one group reported a survival of adult wild-type pig islets of over 600 days. On the other hand, the progress in these preclinical trials strongly affected not only the xenotransplantation study itself but regeneration studies to use pigs as a scaffold to foster human induced pluripotent stem cells.
Of policy considerations from the NY'98 Workshop -- pt. I. Transplantation. 1. International transplantation issues: problems and needs. 2. Immunological hurdles for transplantation. 3. New approaches to induce tolerance -- pt. II. Xenotransplantation. 1. A historical perspective. 2. Pigs as organ donors. 3. Baboons as organ donors -- pt. III. International policy issues in xenotransplantation. 1. Handling the risk: the challenge of international surveillance. 2. International co-operation. 3. Lessons learned in gene therapy. 4. Industry involvement. 5. Economic aspects. 6. Socio-legal and ethical aspects -- Concluding considerations -- Annex I. Working Party on Xenografts (of the Nuffield Council on Bioethics): Summary of Recommendations -- Annex II. Article 152 of the Amsterdam Treaty (ex Article 129) -- Annex III. Recommendation of the Council of Europe -- Annex IV. Workshop on Transplantations, Including Xenotransplantations: Proposed Strategy for Developing Research into and Accessibility to these Technologies in Africa and the Third World -- Annex V. Joint OECD-New York Academy of Sciences Workshop Programme -- Annex VI. Steering and Expert Group for the Preparation of the OECD Workshop New York '98 -- References.
This title was first published in 2003. Xenotransplantation - the transplantation of animal organs into humans - poses a fascinating moral dilemma. Should this ability to extend the lives of millions of older people be permitted given that it might trigger a new pandemic similar to AIDS? This study examines the moral dilemma from a combination of humanistic, legalistic, bioethical, economical and technological perspectives. The first part of the book demonstrates that xenografts are the only realistic near-term technological answer to the organ shortage problem. The balance of the book is devoted to assessing whether doctrines such as the 'right to health care' trump the moral and ethical conundrums posed by xenotransplantation. The book concludes with a 'geoethical' solution that proposes authorization of xenotransplantation subject to the prior implementation of a new international organization for epidemiology and basic health care. It also suggests that the costs of operating such an organization could be covered by a global tax on xenografts.
