Regulatory aspects of pig-to-human islet transplantation

Xenotransplantation

Volumn 15, Issue 2, 2008, Pages 116-120

  Schuurman, Henk Jan ^a  

^a UNIVERSITY OF MINNESOTA MEDICAL SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL RESEARCH; CONFERENCE PAPER; GOVERNMENT; HUMAN; INFECTION RISK; INTERNATIONAL COOPERATION; NONHUMAN; PANCREAS ISLET TRANSPLANTATION; PATIENT SAFETY; PRACTICE GUIDELINE; PRIORITY JOURNAL; XENOTRANSPLANTATION;

ANIMALS; CLINICAL TRIALS AS TOPIC; HUMANS; INFECTION; ISLETS OF LANGERHANS TRANSPLANTATION; PATIENTS; RISK FACTORS; SAFETY; SWINE; TIME FACTORS; TRANSPLANTATION, HETEROLOGOUS;

EID: 42649120673     PISSN: 0908665X     EISSN: 13993089     Source Type: Journal    
DOI: 10.1111/j.1399-3089.2008.00467.x     Document Type: Conference Paper

References (38)

1. Patience C, Takeuchi Y, Weiss RA. Infection of human cells by an endogenous retrovirus of pigs. Nat Med 1997 3 : 282 286.
2. Nuffield Council on Bioethics. Animal-to-Human Transplants: the Ethics of Xenotransplantation. London, UK : Nuffield Council of Bioethics, 1996.
3. The Advisory Group on the Ethics on Xenotransplantation. Animal Tissue Into Humans. London, UK : Department of Health, 1997.
4. Tibell A. Regulating clinical xenotransplantation in Europe. Graft 2001 4 : 157 159.
5. Tibell A, Lundgren T. Xenotransplantation - clinical activities and regulatory development. Acta Vet Scand 2002 99 (Suppl. 19 23.
6. Report on the State of the Art in the Field of Xenotransplantation. http://www.coe.int/t/e/legal_affairs/legal_co-operation/bioethics/activities/ xenotransplantation/_Summary.asp#TopOfPage.
7. Council of Europe, Committee of Ministers. Recommendation Rec(2003)10 of the Committee of Ministers to Member States on Xenotransplantation. https://wcd.coe.int/ViewDoc.jsp?id=45827&BackColorInternet= 9999CC&BackColorIntranet=FFBB55&BackColorLogged=FFAC75.
8. Cooper DKC. Draft reports for public comment from the US Secretary's Advisory Committee on Xenotransplantation. Xenotransplantation 2005 12 : 255 257.
9. U.S. Department of Health and Human Services. US Public Health Service guideline on infectious disease issues in xenotransplantation. MMWR 2001 50 : 1 46.
10. Food and Drug Administration. Guidance for Industry: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans 2003. http://www.fda.gov/cber/guidelines. htm.
11. Bloom ET. Xenotransplantation - federal regulatory considerations. Curr Top Microbiol Immunol 2003 278 : 239 251.
12. Patience C. Porcine endogenous retrovirus in xenotransplantation. Curr Opin Organ Transplant 2005 10 : 334 337.
13. Patience C, Stoye J. Infectious risks of clinical xenotransplantation. Curr Opin Organ Transplant 2004 9 : 176 180.
14. Switzer WM, Michler RE, Shanmugam V et al. Lack of cross-species transmission of porcine endogenous retrovirus infection to nonhuman primate recipients of porcine cells, tissues, or organs. Transplantation 2001 71 : 959 965.
15. Moscoso I, Hermida-Prieto M, Manez R et al. Lack of cross-species transmission of porcine endogenous retrovirus in pig-to-baboon xenotransplantation with sustained depletion of anti-alpha-gal antibodies. Transplantation 2005 79 : 777 782.
16. Nishitai R, Ikai I, Shiotani T et al. Absence of PERV infection in baboons after transgenic porcine liver perfusion. J Surg Res 2005 124 : 45 51.
17. Levy MF, Crippin J, Sutton S et al. Liver allotransplantation after extracorporeal hepatic support with transgenic (hCD55/hCD59) porcine livers: clinical results and lack of pig-to-human transmission of the porcine endogenous retrovirus. Transplantation 2000 69 : 272 280.
18. Denner J. Porcine endogenous retroviruses (PERVs) and xenotransplantation: screening for transmission in several clinical trials and in experimental models using non-human primates. Ann Transplant 2003 8 : 39 48.
19. Elliott RB, Escobar L, Garkavenko O et al. No evidence of infection with porcine endogenous retrovirus in recipients of encapsulated porcine islet xenografts. Cell Transplant 2000 9 : 895 901.
20. Di Nicuolo G, Van De Kerkhove MP, Hoekstra R et al. No evidence of in vitro and in vivo porcine endogenous retrovirus infection after plasmapheresis through the AMC-bioartificial liver. Xenotransplantation 2005 12 : 286 292.
21. Irgang M, Sauer IM, Karlas A et al. Porcine endogenous retroviruses: no infection in patients treated with a bioreactor based on porcine liver cells. J Clin Virol 2003 28 : 141 154.
22. Paradis K, Langford G, Long Z et al. Search for cross-species transmission of porcine endogenous retrovirus in patients treated with living pig tissue. The XEN 111 Study Group. Science 1999 285 : 1236 1241.
23. Specke V, Schuurman H-J, Plesker R et al. Virus safety in xenotransplantation: first exploratory in vivo studies in small laboratory animals and non-human primates. Transpl Immunol 2002 9 : 281 288.
24. Sykes M, D'apice A, Sandrin M, (IXA Ethics Committee). Position paper of the Ethics Committee of the International Xenotransplantation Association. Xenotransplantation 2003 10 : 194 203.
25. Fifty-Seventh World Health Assembly, Agenda item 12.14, May 22, 2004. Resolution 57.18. http://www.who.int/gb/ebwha/pdf_files/WHA57/A57_R18-en.pdf.
26. Groth CG. Towards developing guidelines on xenotransplantation in China. Xenotransplantation 2007 14 : 358 359.
27. Grose S. Critics slam Russian trial to test pig pancreas for diabetics. Nature Med 2007 13 : 390 391.
28. Chapman LE. Xenotransplantation: public health risks - patient vs. society in an emerging field. Curr Top Microbiol Immunol 2003 278 : 23 45.
29. Onions D, Cooper DKC, Alexander TLJ et al. An approach to the control of disease transmission in pig-to-human xenotransplantation. Xenotransplantation 2000 7 : 143 155.
30. Fishman JA. Infection in xenotransplantation. J Card Surg 2001 16 : 363 373.
31. Fishman JA, Patience C. Xenotransplantation: infectious risk revisited. Am J Transplant 2004 4 : 1383 1390.
32. Oxford JS. Influenza A pandemic of the 20th century with special reference to 1918: virology, pathology and epidemiology. Rev Med Virol 2000 10 : 119 133.
33. Parashar UD, Sunn LM, Ong F et al. Case-control study of risk factors for human infection with a new zoonotic paramyxovirus, Nipah virus, during a 1998-1999 outbreak of severe encephalomyelitis in Malaysia. J Infect Dis 2000 181 : 1755 1759.
34. Wells DL, Hopfensperger DJ, Arden NH et al. Swine influenza virus infections. Transmission from ill pigs to humans at a Wisconsin agricultural fair and subsequent probable person-to-person transmission. JAMA 1991 265 : 478 481.
35. Heath CA, Barker RA, Esmonde TFG et al. Dura mater associated Creutzfeldt-Jacob disease: experience from surveillance in the UK. J Neurol Neurosurg Psychiatry 2006 77 : 880 882.
36. Institute of Laboratory Animal Resources, Commission on Life Sciences, National Research Council. Guide for the Care and Use of Laboratory Animals. Washington : National Academy Press, 1996.
37. Spillman MA, Sade RM. Clinical trials of xenotransplantation: waiver of the right to withdraw from a clinical trial should be required. J Law Med Ethics 2007 35 : 265 272.
38. Ericsson TE, Takeuchi Y, Templin C et al. Identification of receptors for pig endogenous retrovirus. Proc Natl Acad Sci USA 2003 100 : 6759 6764.