Xenotransplantation

Xenotransplantation

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Author(s):
OECD
06 Apr 1999
Pages:
116
ISBN:
9789264172654 (PDF) ;9789264170308(print)
http://dx.doi.org/10.1787/9789264172654-en

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Over one million people world-wide have benefited from successful tissue and organ transplants and survival rates have dramatically improved. But transplantation has become a victim of its own success. The demand for human organs can no longer be met and deaths of persons on waiting lists have more than doubled since 1988. A number of alternatives have been proposed to fill the gap between the supply and demand of organs and the past few years have seen the development of various approaches derived from recent advances in biotechnology. Among these technologies is xenotransplantation - the transplantation of viable cells, tissues and organs from one animal species to another. Xenotransplantation of cells and tissues has been approved for clinical trials in a number of OECD countries. However, opinions about the risks from these early procedures and whether to proceed any further vary. At the New York 1998 Workshop on "International issues in transplantation biotechnology including the use of non-human cells, tissues and organs", world leaders in the field reported on the state of the art and unmet needs in transplantation, addressing in particular the potential, the risks, the ethics and socio-economic impacts of xenotransplantation. 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.

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Table of Contents

SUMMARY OF POLICY CONSIDERATIONS FROM THE NY’98 WORKSHOP
Part I. Transplantation
1. INTERNATIONAL TRANSPLANTATION ISSUES: PROBLEMS AND NEEDS
-The core of the problem: the shortage of organ donors
-Can the organ procurement gap be narrowed?
2. IMMUNOLOGICAL HURDLES FOR TRANSPLANTATION
-Current methods to prevent rejection
-New immunosuppressive drugs
-Infections in organ transplant recipients on immunosuppressive treatment
3. NEW APPROACHES TO INDUCE TOLERANCE
-Inbred miniature swine and cloning
Part II. Xenotransplantation
1. A HISTORICAL PERSPECTIVE
2. PIGS AS ORGAN DONORS
-Science: perspectives and issues
-Will pig organs be physiologically capable of supporting prolonged human life
-Infectious risk: What precautions should be taken to avoid the transfer of porcine pathogens?
-Micro-organisms that pigs may harbour
3. BABOONS AS ORGAN DONORS
-What is the risk of infectious disease when performing baboon-to-man transplants
Part III. International Policy Issues in Xenotransplantation
1. HANDLING THE RISK: THE CHALLENGE OF INTERNATIONAL SURVEILLANCE
-Notification systems
-Registry systems
-Archive systems
2. INTERNATIONAL CO-OPERATION
-Current developments on national and international draft guidelines on xenotransplantation
3. LESSONS LEARNED IN GENE THERAPY
4. INDUSTRY INVOLVEMENT
5. ECONOMIC ASPECTS
6. SOCIO-LEGAL AND ETHICAL ASPECTS
-Legal issues
-Ethical issues
-Animal welfare and husbandry
-Public perception
-Developing countries
-Patient monitoring
CONCLUDING CONSIDERATIONS
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What is the actual economic burden to society of diseases where xenotransplantation may have a role?
-What are the options today to alleviate organ shortage?
-What are the options today to alleviate the burden of disease where xenotransplantation may have a role?
-What are the options for treatment derived from recent technological advances?
-What public health tools are there to reduce or eliminate the risk of transmission of infectious agents?
-What are the key features of an international framework to detect, identify, monitor, evaluate and manage xenozoonotic risk
-What can we learn from the international regulatory experience on gene therapy?
-How can the OECD and other international organisations assist the development of international public health tools?
-What can we learn about animal welfare and about accessibility, equity and acceptance in the context of xenotransplantation?
-What are the salient features that prevent the adoption of xenotransplantation?
-What are the research gaps that must be addressed to move the field forward?
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

 
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