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9 Hammer C., Linke R., Wagner F., Diefenbeck M., Organs from animals for man, Int. Arch. Allergy Immunol., 1998, 116:5-21; Cooper D.K.C, Ye Y., Rolf J.L.L., et al., The Pig as Potential Organ Donor for Man. In: Cooper DKC, Kemp E, Reemtsma K, White DJG, eds. Xeno-transplantation. The Transplantation of Organs and Tissues Between Species. 1st ed. Berlin: Springer-Verlag 1991: 481-500. [Back]
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11 Starzl T.E., Rao A.S., Murase N., et al., Will xenotransplantation ever be feasible?, J Am Coll Surg 1998, 186 (4):383-7. [Back]
12 Auchincloss H.Jr., Sachs D.H., Xenogenic transplantation, Annu.Rev.Immunol. 1998, 16:433-70. [Back]
13 Platt J.L., Fischel R.J., Matas A.J., et al., Immunopathology of hyperacute xenograft rejection in a swine-to-primate model, Transplantation 1991, 52:214-220; Dalmasso A.P., Vercellotti G.M., Fischel R.J., et al., Mechanisms of complement activation in the hyperacute rejection of porcine organs transplanted into primate recipients, Am J Pathol 1992, 140:1157-66. [Back]
14 Good A.H., Cooper D.K.C., Malcom A.J. et al., Identification of carbohydrate structures which bind human antiporcine antibodies: implications for discordant xenografting in man, Transplant Proc 1992, 24:559-60; Sandrin M.S., Vaughan H.A., Dabkowski P.L., et al., Anti-pig IgM antibodies in human serum react predominantly with Gal(a1-3)Gal epitopes, PNAS 1993, 90:11391-5. [Back]
15 Leventhal J.R., John R., Fryer J.P., et al., Removal of baboon and human antiporcine IgG and IgM natural antibodies by immunoadsorption: Results of in vitro and in vivo studies, Transplantation 1995, 59:294-300; Cooper D.K.C., Lexer G., Rose A.G., et al., Effects of cyclosporine and antibody adsorption on pig cardiac xenograft survival in the baboon, J. Heart. Transplant. 1988, 7:238-46; Latinne D., Soares M., Havaux X., et al., Depletion of IgM xenoreactive natural antibodies by injection of anti-mu monoclonal antibodies, Immunol Rev 1994, 141:95-125; Rydberg L., Hallberg E., Bjorck S., et al., Studies on the removal of anti-pig xenoantibodies in the human by plasmapheresis/immunoadsorption, Xenotransplantation 1995, 2:253-63. [Back]
16 Gewurz H., Clark D.S., Finstad J., et al., Role of the complement system in graft rejections in experimental animals and man, Ann N Y Acad Sci 1966, 129:673-713; Pruitt S.K., Kirk D.A., Bollinger R.R., et al., The effect of soluble complement receptor type1 on hyperacute rejection of porcine xenografts, Transplantation 1994, 57:363-70; Kobayashi T., Neethling F.A., Koren E., et al., In vitro and in vivo investigation of anticomplement agents FUT-175 and K76COOH, in the prevention of hyperacute rejection following discordant xenotransplantation in a nonhuman primate model, Trans Proc 1996, 28:604; Kroshus T.J., Rollins S.A., Dalmasso A.P., et al., Complement inhibition with an anti-C5 monoclonal antibody prevents acute cardiac tissue injury in an ex vivo model of pig-to-human xenotransplantation, Transplantation 1995, 60:1194-202. [Back]
17 Bach F.H., Turman M.A., Vercellotti G.M., et al., Accommodation: a working paradigm for progressing toward clinical discordant xenografting, Transplant Proc. 1991;23: 205-7; Dalmasso A.P., Vercellotti G.M., Platt J.L., Bach F:H., Inhibition of complement mediated endothelial cell cytotoxicity by decay accelerating factor. Potential for prevention of xenograft hyperacute rejection, Transplantation 1991; 52:530-3. [Back]
18 Diamond L.E., Quinn C.M., Martin M.J., et al., A human CD46 transgenic pig model system for the study of discordant xenotransplantation, Transplantation 2001; 7: 132; Cozzi E., White D.J.G., The generation of transgenic pigs as potential organ donors for humans, Nature Medicine 1995, 1:964-6; Fodor W.L., Williams B.L., Matis L.A., et al., Expression of a functional human complement inhibitor in a transgenic pig as a model for the prevention of xenogenic hyperacute organ rejection, Proc Natl Acad Sci 1994, 91:11153-7; McCurry K.R., Kooyman D.L., Alvarado C.G., et al., Human complement regulatory proteins protect swine-to-primate cardiac xenografts from tumoral injury, Nature Med 1995, 1:423-7; Cowan P.J., Aminian A., Barlow H., et al., Renal xenografts from triple-transgenic pigs are not hyperacutely rejected but cause coagulopathy in non-immunosuppressed baboons, Transplantation 2000, 69:2504-15; Lavitrano M, Forni M, Varzi V, et al., Sperm-mediated gene transfer: production of pigs transgenic for a human regulator of complement activation, Transplant Proc 1997;29:3508-9. [Back]
19 Sandrin M.S., Fodor W.L., Mouhtouris E., et al., Enzymatic remodeling of the carbohydrate surface of a xenogenic cell substantially reduces human antibody binding and complement-mediated cytolysis, Nature Medicine 1995, 1:1261-7. [Back]
20 Soares M.P., Lin Y., Sato K., et al., Pathogenesis of and potential therapies for delayed xenograft rejection, Opin Organ Transplant 1999 4:80-8. [Back]
21 Hancock W.W., Delayed xenograft rejection, World J.Surg. 1997, 21:917-23; Platt J.L., Lin S.S. and McGregor C.G.A., Acute vascular rejection, Xenotransplantation 1998, 5:169-175. [Back]
22 Cozzi E., Bhatti F., Schmoeckel M. et al., Long-term survival of nonhuman primates receiving life-supporting transgenic porcine kidney xenografts, Transplantation 2000, 70:15-21; Vial C.M., Ostlie D.J., Bhatti FN. et al., Life supporting function for over one month of a transgenic porcine heart in a baboon, J Heart Lung Transplant 2000, 19:224-9. [Back]
23 Bach F.H., Xenotransplantation: problems and prospects, Annu.Rev.Med.1998, 49:301-10. [Back]
24 Yamada A., Auchincloss H.Jr., Cell-mediated xenograft rejection, Current Opinion in Organ Transplantation 1999, 4: 90-94. [Back]
25 Auchincloss H.Jr., Sachs D.H., Xenogenic transplantation, Annu.Rev.Immunol. 1998, 16:433-70. [Back]
26 Bach F.H., Ferran C., Soares M., et al., Modification of vascular responses in xenotransplantation: inflammation and apoptosis, Nat. Med 1997. 3:944-8. [Back]
27 Soares M.P., Lin Y., Sato K., et al., Pathogenesis of and potential therapies for delayed xenograft rejection, Opin Organ Transplant 1999 4:80-8; Hasan R.I.R., van den Bogarde J., Forty J., et al., Prolonged Survival of Hamster to Rat Heart xenografts with Cyclophosphamide Therapy, Transplant Proceedings 1992, 24:517-518. [Back]
28 Hasan R.I.R., van den Bogarde J., Forty J., et al., Prolonged Survival of Hamster to Rat Heart xenografts with Cyclophosphamide Therapy, Transplant Proceedings 1992, 24:517-518. [Back]
29 Soares M.P., Lin Y., Sato K., et al., Accommodation, Immunol Today 1999, 20:434-7. [Back]
30 Soares M.P., Lin Y., Sato K., et al., Accommodation, Immunol Today 1999, 20:434-7; Lin Y., Soares M.P., Sato K., et al., Accommodated xenografts survive in the presence of anti-donor antibodies and complement that precipitate rejection of naive xenografts, J Immunol. 1999 Sep 1;163(5):2850-7. [Back]
31 Alexandre G.P.J, Latinne D., Gianello P., et al., Preformed cytotoxic antibodies and ABO-incompatible grafts, Clin Transpl 1991; 5: 583-587. [Back]
32 Cozzi E., Bhatti F., Schmoeckel M. et al., Long-term survival of nonhuman primates receiving life-supporting transgenic porcine kidney xenografts, Transplantation 2000, 70:15-21; Vial C.M., Ostlie D.J., Bhatti FN. et al., Life supporting function for over one month of a transgenic porcine heart in a baboon, J Heart Lung Transplant 2000, 19:224-9. [Back]
33 McCurry K.R., Kooyman D.L., Alvarado C.G., et al., Human complement regulatory proteins protect swine-to-primate cardiac xenografts from tumoral injury, Nature Med 1995, 1:423-7; Cozzi E., Yannoutsos N., Langford G.A. et al., Effect of transgenic expression of human decay-accelerating factor on the inhibition of hyperacute rejection of pig organs. In: Cooper DKC, Kemp E, Platt JL, White DJG, eds. Xeno-transplantation. The Transplantation of Organs and Tissues Between Species. 2nd ed. Berlin: Springer-Verlag 1997: 665-682. [Back]
34 Cozzi E., Bhatti F., Schmoeckel M. et al., Long-term survival of nonhuman primates receiving life-supporting transgenic porcine kidney xenografts, Transplantation 2000, 70:15-21; Bhatti F.N., Schmoeckel M., Zaidi A et al., Three-month survival of HDAF transgenic pig hearts transplanted into primates, Transplant Proc. 1999, 31: 958; McCurry K.R., Kooyman D.L., Alvarado C.G., et al., Human complement regulatory proteins protect swine-to-primate cardiac xenografts from tumoral injury, Nature Med 1995, 1:423-7. [Back]
35 Bhatti F.N., Schmoeckel M., Zaidi A et al., Three-month survival of HDAF transgenic pig hearts transplanted into primates, Transplant Proc. 1999, 31: 958. [Back]
36 Vial C.M., Ostlie D.J., Bhatti FN. et al., Life supporting function for over one month of a transgenic porcine heart in a baboon, J Heart Lung Transplant 2000, 19:224-9. [Back]
37 Cozzi E., Bhatti F., Schmoeckel M. et al., Long-term survival of nonhuman primates receiving life-supporting transgenic porcine kidney xenografts, Transplantation 2000, 70:15-21. [Back]
38 Onions D., Cooper D.K., Alexander T.J., et al., An approach to the control of disease transmission in pig-to-human xenotransplantation, Xenotransplantation 2000; 7:143-155. [Back]
39 Iverson W.O., Talbot T., Definition of a production Specification for xenotransplantation, Ann NY Acad Sc 1998, 862:121-124. [Back]
40 Boeke J.D., Stoye J.P., Retrotransposons, endogenous retroviruses, and the evolution of retroelements, Chapter 8 In: Retroviruses. (J. M. Coffin, S. H. Hughes, and H. E. Varmus eds) Cold Spring Harbor Press, Cold Spring Harbor, N.Y. 1997; 343-435. [Back]
41 Patience C, Takeuchi Y, Weiss RA, 1997, Infection of human cells by an endogenous retrovirus of pigs. Nature Med 3:282-286. [Back]
42 Paradis K, Langford G, Zhifeng L, Heneine, Sandstrom P, Switzer W, Chapman L, Lockey C, Onions D, The XEN111 Study group, et al, 1999, Search for cross-species transmission of porcine endogenous retrovirus in patients treated with living pig tissue. Science 285:1236-41. [Back]
43 Polejaeva I.A., Chen S.H., Vaught T.D., et al., Cloned pigs produced by nuclear transfer from adult somatic cells, Nature. 2000, 407:86-90; Onishi A., Iwamoto M., Akita T., et al., Pig cloning by microinjection of fetal fibroblast nuclei, Science. 2000, 289:1188-90. [Back]
44 Harvey D.M., Caskey C.T., Inducible control of gene expression: prospects for gene therapy, Curr Opin Chem Biol 1998, 2:512-8. [Back]
45 Groth C.G., Korsgren O., Tibell, A., et al., Transplantation of Porcine fetal pancreas to diabetic patients, Lancet, 1994, 344:1402-1404. [Back]
46 Brevig T., Holgersson J., Widner H., Xenotransplantation for CNS repair: immunological barriers and strategies to overcome them, Trends Neurosci 2000; 23: 337-44. [Back]
47 Mc Laughlin B.E., Tosone C.M., Custer L.M., Mullon C., Overview of extracorporeal liver support system and clinical results, Ann. NY Acad. Sci., 1999, 875: 310-325; Calise F., Mancini A., Amoroso P. et al., Functional evaluation of the AMC-BAL to be employed in a multicenter clinical trial for acute liver failure, Transpl. Proceed., 2001, 33: 647-649. [Back]
48 Cooper D.K.C., Keogh A.M., Brink J., et al., Report of the xenotransplantation advisory committee of the international society for heart and lung transplantation. The present status of xenotransplantation and its potential role in the treatment of end-stage cardiac and pulmonary disease. J. Heart Lung Transpl. 2000, 19:1125-1165. [Back]
49 Cozzi E., Bhatti F., Schmoeckel M. et al., Long-term survival of nonhuman primates receiving life-supporting transgenic porcine kidney xenografts, Transplantation 2000, 70:15-21; Vial C.M., Ostlie D.J., Bhatti FN. et al., Life supporting function for over one month of a transgenic porcine heart in a baboon, J Heart Lung Transplant 2000, 19:224-9; Bhatti F.N., Schmoeckel M., Zaidi A et al., Three-month survival of HDAF transgenic pig hearts transplanted into primates, Transplant Proc. 1999, 31: 958. [Back]
50 The reference is made to the narrative scheme, of a theological-liturgical nature, used in Gen. 1:1-31; for a fuller understanding of the biblical anthropological context, from a protological point of view, the second account of creation, in Gen. 2:,1-25, must also be taken into consideration. [Back]
51 John Paul II, Encyclical Letter Laborem Exercens, n. 4. [Back]
52 Second Vatican Council, Dogmatic Constitution Lumen Gentium, n. 36. [Back]
53 Second Vatican Council, Decree Apostolicam Actuositatem, n. 7. [Back]
54 Saint Irenaeus of Lyons, Against Heresies, Book 4, 20, 7. [Back]
55 Bondolfi A., I rapporti tra uomo e animale nelle tradizioni giudaico-cristiane e la sfida degli xenotrapianti, in L'arco di Giano, 1999; 21: 49-62; D'Agostino F., I diritti degli animali, in Bioetica nella prospettiva della filosofia del diritto, 1997, Giappichelli Ed., Torino, pp. 239-265. [Back]
56 Singer P., Animal Liberation, 2nd edit., 1995, Pimlico, London; Regan T., The case for Animal Rights, 1983, London, Routledge & Kegan Paul; Christian Medical Fellowship, Animal experimentation, 1997, (http://www.cmf.org.uk, 10/7/2001). [Back]
57 Reflections on human responsibility for animal life may be found in Schockenhoff E., Etica della vita. Un compendio teologico, Brescia: Queriniana 1997: 407-451. [Back]
58 The Old Testament precept by which certain animals were held to be impure (cf. Lev 11:3-8, 26-29), is considered abolished by Christ (cf. Mk 7:14-23; Acts 10:14-15; Rom 14:14). [Back]
59 It should be noted that "identity indicators" in human beings are many (objective: name, sex, age, etc.; cultural: language, religion, ideology, etc.; group - social - professional). [Back]
60 Grinberg L. e R., Identità e cambiamento, Roma: Armando, 1992; Jervis G., La conquista dell'identità: essere se stessi, essere diversi, Milano: Feltrinelli, 1997. [Back]
61 We do well to specify that, while the encephalon is related to the personal identity of the subject insofar as it is the organ representing the "principal seat of psychological consciousness", and the "deposit" of existential memory, the gonads are likewise related, insofar as they are organs charged with gametogenesis (the production of gametes); they represent, in a manner of speaking, the "transmitter" -- by means of procreation - of the subject's personal identity (genetic patrimony) to offspring. For this reason, while an hypothetical encephalon transplant can in no case be considered morally licit, neither can an eventual gonad transplant -- if performed for the purpose of supplying the gametogenetic function -- be morally acceptable. Different, however, is the case of a gonad transplant performed exclusively for hormonogenetic purposes (that is, to restore a sufficient hormonal function); once the integrity of the subject's personal identity has been ensured, and once the disassociation with procreation has been astablished, there would be no particular moral reservations. In this regard, see M.P. Faggioni, 'Il trapianto di gonadi. Storia e attualità', Med. Mor., 1998, 48, 15-46. [Back]
62 Cuer P., Quelques considèrations ethiques, notamment sur l'identite lors de xenotrasplantations, Path Biol (Paris) 2000, 48: 426-428. [Back]
63 John Paul II, Address to the Participants at a Congress on Organs Transplantation (20 June 1991) in Insegnamenti di Giovanni Paolo II, XIV/1, 1991, p. 1711; Catechism of The Catholic Churc (1994) n. 2296; John Paul II, Enc Lett.. Evangelium Vitae (1995) n. 86; Pont. Counc. Past. Assist. Health Care Workers., Charter for Health Care Workers (1995), nn. 83-91; John Paul II, Address to the Eighteenth International Congress of the Transplant Society, 29 August 2000. [Back]
64 For an overview of the current debate see: Caplan A.L., Is Xenografting Morally Wrong?, Transplantation Proceedings, 1992, 24:722-727; Hanson M.J., The Seductive Sirens of Medical Progress. The case of Xenotransplantation, Hastings Center Report 1995, 25: 5-6; Nuffield Council of Bioethics, Animal-to-Human Transplants: the Ethics of Xenotransplantation, London: Nuffield Council of Bioethics, 1996; Mc Carthy Ch.R., A New Look at Animal-to-Human Organ Transplantation, Kennedy Institute of Ethics Journal, 1996, 6: 183-188; U.S. Institute of Medicine Committee on Xenograft Transplantation, Xenotransplantation: Science, Ethics, and Public Policy, Washington: National Academy Press, 1996 ; Bach F.H., Fishman J.A., Daniels N., et al., Uncertainty in Xenotransplantation: Individual Benefit versus Collective Risk, Nature Medicine, 1998, 4: 141-144; Hughes J., Xenografting: Ethical Issues, Journal of Medical Ethics, 1998, 24: 18-24; Vanderpool H.Y., Critical Ethical Issues in Clinical Trials with Xenotransplants, The Lancet, 1998, 351: 1347-1350; Clark M.A., This Little Piggy Went to Market: The Xenotransplantation and Xenozoonose Debate, Journal of Law, Medicine and Ethics, 1999, 27: 137-152; Comite Consultatif National d'Ethique pour les sciences de la vie et de la sante (France), Avis sur l'ethique et la xenotransplantation, n.61, 11 juin 1999; Cooper D.K.C., Lanza R.P., Xeno, the Promise of Transplanting Animal Organs into Humans, New York: Oxford University Press 2000; U.S. Dpt. Healt & Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Source animal, product, preclinical, and clinical issues concerning the use of Xenotransplantation products in humans: guidance for industry (Draft, February 2001), (http://www.fda.gov/cber/guidelines.htm). [Back]
65 Schöne-Seifert B., Risk, in Reich T.W. (ed.), Encyclopedia of Bioethics, vol. 4, New York: MacMillan 1995 (revised edition), 2316-2321. [Back]
66 An overview of social reactions to different aspects of xenotransplantation: Appel J.Z., Alwayn I.P., Cooper D.K., Xenotransplantation: The Challenge to Current Psychological Attitudes, Prog Transplant 2000, 10: 217-225. [Back]
67 Beckmann J.P., Xenotransplantation aus ethischer Sicht. Eine Skizze, Zentralbl Chir 1999, 124: 636-640; Welin S., Starting Clinical Trials of Xenotransplantation. Reflections on the Ethics of the Early Phase, J Med Ethics 2000, 26: 231-236. [Back]
68 In this regard, polls have been taken to ascertain the level of public acceptance of eventual xenotransplantation. See, for example, Mohacsi P.J., Blumer E.C., Quine S. et Al., Aversion to Xenotransplantation, Nature, 1995, 378:434; National Kidney Federation, Survey reveals positive feelings on animal-to-human transplants, Dialysis and Transplantation, 1995, p. 677; Mohacsi P.J. et Al., Patients attitudes to xenotransplantations, Lancet 1997, 349:1031. [Back]
69 Crafen J., Rodin G.M., Psychiatric Aspects of Organ Transplantation, New York: Oxford Medical Publications, 1992. [Back]
70 Barker J.H., Polcrack L., Respect for persons, informed consent and the assessment of infectious disease risks in xenotransplantation, Med Health Care Philos 2001, 4(1): 53-70. [Back]
71 Kress J.M., Xenotransplantation: ethics and economics, Food Drug Law Journal 1998, 53 (2):353-384; Urruela Mora A., Workshop on the ethical, sociologic, economic and legal aspects of xenotransplantation, Law Hum Genome Rev 2000 Jan-Jun;(12):245-6. [Back]
72 Trattato di Cooperazione sui Brevetti (Washington, 1970), art.33; Convenzione del Brevetto Europeo (Monaco di Baviera, 1973), 54-57; vedi anche Marchetti P., Ubertazzi L.C., Commentario breve al diritto della concorrenza, Padova, CEDAM, 1997:1343. [Back]
73 WIPO/OMPI, Introduction to Intellectual Property: Theory and Practice, Kluwer Law International, London 1998: 145-150; Accordo di Marrakech istitutivo dell'Organizzazione Mondiale del Commercio, Annesso 1C: Accordo sugli aspetti della proprietà intellettuale relativi al commercio (Marrakech, 1994), art.31. [Back]
74 To give a few examples of some important organizations that have drafted guidelines in this area, we list the following: the Council of Europe, the Health Council of the Netherlands, the Swedish Committee on Xenotransplantation, the Spanish Xenotransplantation Sub-committee, the Argentine National Commission on Xenotransplantation, the US Department of Health and Human Services Committee on Xenotransplantation, the United Kingdom Xenotransplantation Interim Regulatory Authority, and the Italian Xenotransplantation Commission. In France, the ethical aspects are currently being examined by the French National Ethics Committee and applications for clinical trials will need the approval of the newly formed Agency for the Security of Health Products and of the Ministry of Health. In Germany, the German Medical Council has established a committee to prepare guidelines on xenotransplantation. In Canada 'Health Canada' has the authority to regulate xenotransplantation as a new technology. [Back]