Skip to main content

Xenotransplantation

Science, Risk and International Regulatory Efforts

  • Chapter

Abstract

Xenotransplantation today is characterized by uncertainty and differences of opinion. The science, in the laboratory, is progressing at a satisfactory pace, with a number of advances; at the same time, however, the science is also indicating that there are significant potential risks.

This is a preview of subscription content, log in via an institution.

Buying options

Chapter
USD   29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD   129.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD   169.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD   169.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Learn about institutional subscriptions

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  • Acute Services Policy Unit. 1994. “Identification of Potential Donors of Organs for Transplantation” London: Department of Health {HSG(94)1}.

    Google Scholar 

  • AGEX. Advisory Group on the Ethics of Xenotransplantation. 1997. Animal Tissues into Humans, London: London Stationery Office.

    Google Scholar 

  • Allan, J.S. 1998. “The Risk of Using Baboons as Transplant Donors. Exogenous and Endogenous Retroviruses” Ann. NY Acad. Sci., Vol. 862, pp. 87–99.

    Article  Google Scholar 

  • Allan, J.S. et al. 1996. “Letter to T.W. Beth” Food and Drug Admin. USA, Dec. 20. Re: Draft PHS guidelines. Document no. 96M-0311.

    Google Scholar 

  • Arnold, R.M. & Youngner, S.J. (Eds.) 1993. ‘Ethical, Psychological, and Public Policy Implication of Procuring Organs from Non-Heart-Beating Cadavers“ Special Issue, Kennedy Institute of Ethics Journal, Vol. 3(2), pp. 103–277.

    Google Scholar 

  • ASTP. American Society of Transplant Physicians. 1996. Comments from the Xenotransplant Committee of the ASTP. Wayne Hancock, Chair. http://www.ASTP.org(posted Dec. 22, 1996).

    Google Scholar 

  • Bach, F.H. & Fineberg, H.V. 1998. “Call for Moratorium on Xenotransplants” Nature, Vol. 391(6665), p. 326.

    Article  Google Scholar 

  • Bach, F.H. et al. 1998. “Uncertainty in Xenotransplantation: Individual Benefit Versus Collective Risk” Nat Med, Vol. 4(2), pp. 141–144.

    Article  Google Scholar 

  • Bailey, L.L. et al. 1985. “Baboon to Human Cardiac Xenotransplantation in a Neonate” JAMA, Vol. 254, p. 3321.

    Article  Google Scholar 

  • Butler, D. 1998. “Briefing” Nature, Jan. 22.

    Google Scholar 

  • Butler, D. 1999a. “Pig in the middle” Nature, Vol. 397, p. 279.

    Article  Google Scholar 

  • Butler, D. 1999b. Transplant panel “Could be Model for Ethics Thinktank.”

    Google Scholar 

  • Caplan, A.L. 1992. “Is Xenotransplantation Morally Wrong?” Transplant Proc, Vol. 24(2), pp. 722–727.

    Google Scholar 

  • Chapman, L.E. 1996. Presentation to the Conference on Xenograft Transplantation: Science, Ethics and Public Policy. Institute of Medicine. June 25–27, 1997, p. 15.

    Google Scholar 

  • Chapman, L.E. et al. 1995. “Xenotransplantation and Xenogeneic Infections” N Eng. J Med., Vol. 333, pp. 1498–1501.

    Article  Google Scholar 

  • CNN. 1999. “Advisers Propose Rules for Stem Cell Research” CNN Interactive. Web posted at: 11.-45 AM EDT. Associated Press. April 9.

    Google Scholar 

  • Collins, B.H., Parker, W. & Platt, J.L. 1994. “Characterization of Porcine Endothelial Cell Determinants Recognized by Human Natural Antibodies” Xenotransplantation, Vol. 1, pp. 36–46.

    Article  Google Scholar 

  • Council on Scientific Affairs. 1985. “Xenografts: Review of the Literature and Current Status” JAMA, Vol. 254, pp. 3353–3357.

    Article  Google Scholar 

  • Cozzi, E. et al. 1997. “Effect of Transgenic Expression of Human Decay-Accelerating Factor on the Inhibition of Hyperacute Rejection of Pig Organs” Xenotransplantation: The Transplatation of Organs and Tissues between Species, D.K.C. Cooper, E. Kemp, J.L. Platt & D.J.G. White (Eds.), Berlin: Springer-Verlag, pp. 665–682.

    Google Scholar 

  • Daar, A.S. 1999. “Animal-to-Human Organ Transplants-A Solution or a New Problem?” (Round Table), World Health Bulletin, Vol. 77(1), pp. 54–81.

    Google Scholar 

  • Daar, A.S. 1998. ‘Analysis of Factors for the Prediction of the Response to Xenotransplantation“ Ann. N.Y. Acad. Sci., Vol. 862, pp. 222–233.

    Article  Google Scholar 

  • Daar, A.S. 1995. “Living-Organ Renal Donation: Time for a Donor Charter” Clinical Transplants (1994), UCLA, pp. 376–380.

    Google Scholar 

  • Daar, A.S. I997a. “Xenotransplants: Proceed with Caution” Nature, Vol. 392, p. 11.

    Article  Google Scholar 

  • Daar, A.S. 1997b. “Ethics of Xenotransplantation: Animal Issues, Consent and Likely Transformation of Transplant Ethics” World J Surgery, Vol. 21, pp. 975–982.

    Article  Google Scholar 

  • Daar, A.S. et al. 1997. “Living-Donor Renal Transplantation: Evidence-Based Justification for an Ethical Option” Transplantation Reviews, Vol. 11, pp. 95–108.

    Article  Google Scholar 

  • Daar, A.S. & Sells, R.A. 1990. “Living Non Related Donor Renal Transplantation -A Reappraisal” Transplantation Reviews, Vol. 4(2), pp. 128–140.

    Article  Google Scholar 

  • Daar, A.S. 1994a. “Xenotransplantation and Religion: The Major Monotheistic Religions” Xeno, Vol. 2(4), pp. 61–64.

    Google Scholar 

  • Daar, A.S. 1994b. “Transplantation in Developing Countries” Kidney Transplantation, Principles and Practice, 4th ed., P.J. Morris (Ed.), Philadelphia: Saunders, pp. 478–503.

    Google Scholar 

  • Deacon, T. et al. 1997. “Histological Evidence of Pig Neural Cell Survival After Transplantation into a Patient with Parkinson’s Disease” Nature Medicine, Vol. 3, pp. 350–353.

    Article  Google Scholar 

  • DHHS. 1999. Department of Health and Human Services. Food and Drug Administration. Center for Biologics Evaluation and Research (CBER). April Guidance For Industry. Public Health Issues Posed by the Use of Non-human Primate Xenografts in Humans. (Available from the Office of Communication, Training and Manufacturers Assistance (HFM-40), 1401 Rockville Pike, Rockville, MD 20852–1448. U.S.)

    Google Scholar 

  • Ethics Committee, The International Transplantation (Sheil, A.G.R. et al.) Society 1997. “The Transplantation Society and Xenotransplantation” Transplantation Soc. Bulletin Issue 6, pp. 11–14.

    Google Scholar 

  • Good, A.H. et al. 1992. “Identification of Carbohydrate Structures that Bind Human Antiporcine Antibodies: Implications for Discordant Xenografting in Humans” Transpl. Proc., Vol. 24, pp. 559–562.

    Google Scholar 

  • Groth, C.G. et al. 1994. “Transplantation of Porcine Fetal Pancreas to Diabetic Patients” Lancet, Vol. 344, pp. 1402–1404.

    Article  Google Scholar 

  • Hammer, C. 1998. “Physiological Obstacles After Xenotransplantation” Ann. NY Acad. Sci., Vol. 862, pp. 19–27.

    Article  Google Scholar 

  • Heneine, W. et al. 1998. “Identification of a Human Population Infected with Simian Foamy Viruses” Nature Medicine, Vol. 4(4), pp. 403–407.

    Article  Google Scholar 

  • IOM. Institute of Medicine. 1996. Xenotransplantation: Science, Ethics and Public Policy. Washington, D.C.: National Acad. Press.

    Google Scholar 

  • Jakobovitz, I. 1975. Jewish Medical Ethics, New York: Bloch Publishing Co.

    Google Scholar 

  • La Prairie, A. 1999. “Current Information on the Status of Xenotransplantation in Canada” Personal Communication, April 28, 1999.

    Google Scholar 

  • LeTissier, P. et al. 1997. “Two Sets of Human-Tropic Pig Retrovirus. Scientific Correspondence” Nature, Vol. 389, pp. 681–682.

    Article  Google Scholar 

  • Lock, M. 1996. “Ideologies and Brain Death in Japan” Organ Transplantation: Meaning and Realities.

    Google Scholar 

  • S.J. Youngner, R.C. Fox & L.J. O’Connel (Eds.), Madison: Univ. Wisconsin Press, pp. 142–167.

    Google Scholar 

  • Morris, P.J. 1999. quoted in: “Claims Animal Organ Transplants Unlikely” Australian Broadcasting Corp. Online News. Monday 8 March, 1999. Comments apparently made at the 12th Biennial Congress of the Asian Surgical Association in Brisbane, March, 1999.

    Google Scholar 

  • Mudur, G. 1999. “Indian Surgeon Challenges Ban on Xenotransplantation” News, BMJ, Vol. 318, p. 79.

    Article  Google Scholar 

  • Mukherjee, M. 1997. “Trends in Animal Research” News Scientist, Feb.

    Google Scholar 

  • Nature. 1998. Opinion. “Halt the Xeno-Bandwagon. Xenotransplantations Risk Makes Moratorium Essential” Nature, Vol. 391, p. 309.

    Article  Google Scholar 

  • Nature. 1995. “Aids Patient Given Baboon Bone Marrow” Nature, Vol. 378, p. 756.

    Google Scholar 

  • Nuffield Council on Bioethics. 1996. Animal-to-Human Transplants. The Ethics of Xenotransplantation, London: Nuffield Council on Bioethics.

    Google Scholar 

  • O’Riardan, T. & Jordan, A. 1995. “The Precautionary Principle in Contemporary Environmental Politics” Environmental Values, Vol. 4, pp. 191–212.

    Article  Google Scholar 

  • OECD. 1998. Policy Considerations on International Issues in Transplantation Biotechnology Including the use of Non-Human Cells, Tissues and Organs, A Report Prepared by Elettra Ronchi, Paris: Organisation For Economic Co-Operation And Development.

    Google Scholar 

  • OECD. 1996. Advances in Transplantation Biotechnology. Animal to Human Organ Transplants. - Xenotransplantation, Paris: Organisation for Economic Cooperation and Development.

    Google Scholar 

  • OECD/NYAS. 1998. “Xenotransplantation: Scientific Frontiers and Public Policy” Ann. NY Acad. Sci., Vol. 862, pp. 1–251.

    Article  Google Scholar 

  • Oman Daily Observer. 1997. “Organ Transplant Doctor Held” Jan. 11.

    Google Scholar 

  • Patience, C., Takeuchi, Y. & Weiss, R.A. 1997. “Infection of Human Cells by an Endogamous Retrovirus of Pigs” Nature Medicine, Vol. 3, pp. 282–286.

    Article  Google Scholar 

  • PHS. 1996. “Public Health Service, Draft Guidelines on Infectious Disease Issues in Xenotransplantation” Fed. Register, Vol. 61(185), pp. 49919–49932.

    Google Scholar 

  • Platt, J.L. & Lin, S.S. 1998. “The Future Promises of Xenotransplantation. Xenotransplantation: Scientific Frontiers and Public Policy” Ann. NY Acad. Sci., Vol. 862, pp. 5–18.

    Article  Google Scholar 

  • Reemtsma, K. et al. 1964. “Renal Hetero-Xenotransplantation in Man” Ann. Surg., Vol. 160, pp. 384–410.

    Article  Google Scholar 

  • Regan, T. 1983. The Case for Animal Rights, Berkeley: Univ. of California Press.

    Google Scholar 

  • Russel, W.M.S. & Burch, R.L. 1959. The Principles of Humane Experimental Technique, London: Methuen.

    Google Scholar 

  • Sachs, D.H. et al. 1998. “Xenotransplantation Caution, But No Moratorium” Nature Medicine, Vol. 4(4), pp. 372–373.

    Article  Google Scholar 

  • Salomon, D.R., Ferguson, R.M. & Helderman, J.H. 1998. “Xenotransplants: Proceed With Caution” Nature, Vol. 392(6671), pp. 11–12.

    Article  Google Scholar 

  • Sandrin, M.S. et al. 1993. “Anti-Pig IgM Antibodies in Human Serum React Predominantly with Gala(1,3) Gal Epitopes” Proc. Natl. Acad. Sci. USA, Vol. 90, pp. 11391–11395.

    Article  Google Scholar 

  • Sandrin, M.S. et al. 1995. “Enzymatic Remodelling of the Carbohydrate Surface of a Xenogeneic Cell Substantially Reduces Human Antibody Binding and Complement-Mediated Cytosis” Nature Medicine, Vol. 1, pp. 1261–1267.

    Article  Google Scholar 

  • Sells, R.A. 1996. “Ethics of Xenotransplantation” Xeno, Vol. 4(2), pp. 18–20.

    Google Scholar 

  • Shamblott, M.J. et al. 1998. “Derivation of Pluripotent Stem Cells from Cultured Human Primordial Germ Cells” Proc Natl Acad Sci USA, Vol. 95(23), pp. 13726–13731.

    Article  Google Scholar 

  • Sharma, A. et al. 1996. “Reduction in the Level of Gal (a1,3) Gal in Transgenic Mice and Pigs by the Expression of an a(1,2) Fucosyltransferase” Proc Natl Acad Sci USA, Vol. 93, pp. 7190–7195.

    Article  Google Scholar 

  • Singer P. 1975. Animal Liberation, New York: Random House.

    Google Scholar 

  • Starzl, T.E. et al. 1993. “Baboon-to-Human Liver Transplantation” Lancet, Vol. 341(8837), pp. 65–71.

    Article  Google Scholar 

  • Stoye, J.P., Tissier, P.L., Takeuchi, Y., Patience, C. & Weiss, R.A. 1998. Endogenous Retroviruses: A Potential Problem for Xenortransplantation? Xenotransplantation. Scientific Frontiers and Public Policy. Ann. NY Acad. Sci. 862: 67–74.

    Article  Google Scholar 

  • Tearle, R.G. et al. 1996. “The a-1,3-Galactosyltransferase Knockout Mouse” Transplantation, Vol. 61, pp. 13–49.

    Article  Google Scholar 

  • Thall, A.D., Maly, P. & Lowe, J.B. 1997. “Oocyte Galal,3Gal Epitopes Implicated in Sperm Adhesion to the Zone Pellucida Glycoprotein ZP3 are Not Required for Fertilization in the Mouse” J Biol Chem, Vol. 270, pp. 21437–21440.

    Google Scholar 

  • Thomson, J.A. et al. 1998. “Embryonic Stem Cell Lines Derived from Human Blastocysts” Science, Vol. 282, pp. 1145–1147.

    Article  Google Scholar 

  • Valpy, M. 1998. “Salvage Group Tackles Sick Kids’ Image Disaster. Business, Medical Ethics Split on Hospital Support for Doctor” The Globe and Mail, Monday, November 2, 12.

    Google Scholar 

  • Wade, N. 1998. “Human Cells Revert to Embryo State, Scientists Assert” NY Times, Nov. 12.

    Google Scholar 

  • Weiss, R. 1998. “Transgenic Pigs and Virus Adaptation” Nature, Vol. 391, pp. 327–328.

    Article  Google Scholar 

  • White, D. & Wallwork, J. 1993. “Xenografting: Probability, Possibility, or Pipe Dream? Lancet, Vol. 342, pp. 879–880.

    Article  Google Scholar 

  • WHO. 1998. “Report of World Health Organization Consultation on Xenotransplantation” Geneva, OSwitzerland, Oct. 28–30, 1997. WHO/EMC/ZO0198.2. Feb. 1998.

    Google Scholar 

  • Williams, R.D. 1996. “Organ Transplants for Animals: Examining the Possibilities” USFDA Homepage.

    Google Scholar 

  • Witt, C.J., Meslin, F-X & Heymann, D. 1997. “Emerging and Other Communicable Disease Surveillance and Control (EMC) Draft World Health Organization Recommendations on Xenotransplantation and Infectious Disease Prevention” WHO, Geneva, Switzerland.

    Google Scholar 

  • World Health Assembly. 1999. “Cloning in Human Health” Report by Secretariat. Provisional Agenda Item 13. (WHA A52/12). April 1, 1999. For WHA in May, 1999.

    Google Scholar 

  • Youngner, S.J. & Arnold, R.M. 1993. “Ethical, Psychological, and Public Policy Implications of Procuring Organs from Non-Heart Beating Cadaver Donors” JA MA, pp. 2769–2774.

    Google Scholar 

Download references

Authors

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 1999 Springer Science+Business Media New York

About this chapter

Cite this chapter

Daar, A.S. (1999). Xenotransplantation. In: Caulfield, T.A., Williams-Jones, B. (eds) The Commercialization of Genetic Research. Springer, Boston, MA. https://doi.org/10.1007/978-1-4615-4713-6_9

Download citation

  • DOI: https://doi.org/10.1007/978-1-4615-4713-6_9

  • Publisher Name: Springer, Boston, MA

  • Print ISBN: 978-1-4613-7135-9

  • Online ISBN: 978-1-4615-4713-6

  • eBook Packages: Springer Book Archive

Publish with us

Policies and ethics