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Volume: 27S1 • July 2001

Report of the Xenotransplantation Surveillance Workshop
Infection Control Database and Sample Archiving

IV: REFERENCES

  1. National Forum on Xenotransplantation: clinical, ethical and regulatory issues, November 1997. URL: <http://www.hc-sc.gc.ca/hpb-dgps/therapeut/zfiles/english/bgtd/frmrptx_e.html>.

  2. Notice to interested parties: intent to develop a regulatory framework for xenografts. URL: <http://www.hc-sc.gc.ca/hpb-dgps/
    th...es/english/btox/notices/noi_e.html>. Date of access: February 6, 1999.

  3. Notice to hospitals from the Therapeutic Products Programme. March 29, 1999. The clinical use of viable animal cells, tissues, or organs to treat patients. URL: <http://www.hc-sc.gc.ca/hpb-dgps/
    th...x/notices/noticetohospitals_e.html>.

  4. Xenotransplantation (Factsheet). Revised July 1999. URL: <http://www.hc-sc.gc.ca/
    hpb-dgps/th.../english/fact-sht/fact_xeno_e.html>.

  5. Adverse Drug Reaction (ADR) Expedited Reporting Summary Form (to be used for ADRs occurring during clinical trials). URL: <http://www.hc-sc.gc.ca/
    hpb-dgps/th...zfiles/english/forms/ct_adr_e.html>.

  6. Preparation of an application for investigational testing (Devices). URL: <http://www.hc-sc.gc.ca/hpb-dgps/
    therapeutic/zfiles/english/guides/meddev/
    test_md3_e.pdf>. Date of access: February 22, 1999.

  7. Mandatory and voluntary problem reporting for medical devices. URL: <http:///www.hc-sc.gc.ca/hpb-dgps/
    therapeutic/zfiles/english/guides/meddev/
    manrpt2_e.pdf>. Date of access: September 14, 1998.

  8. Proposed Canadian Standard for Xenotransplantation. URL: <http://www.hc-sc.gc.ca/hpb-dgps/therapeut/
    zfiles/english/btox/Standard/xeno_std_e.html>.

  9. PHS Guideline on Infectious Disease Issues in Xenotransplantation. (61 Federal Register 49919). URL: <http://www.fda.gov/cber/gdlns/xeno.txt>. Date of access: September 23, 1996.

  10. PHS Guideline on Infectious Disease Issues in Xenotransplantation.. URL: <http://www.fda.gov/cber/gdlns/xeno0500.pdf>. Date of access: May 26, 2000.

  11. Agency information collection activities; proposed collection; comment request, Food and Drug Administration, HHS, Docket No. 96M-0311 and see Federal Register website, URL: <http://frwebgate.access.gpo.gov/
    cgi-bin/...bname=2000_register&docid=00-13340-filed>.

  12. Guidelines for reporting adverse events associated with vaccine products. CCDR 2000;26(S1). See Website: http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/00vol26/26s1/.

  13. Council of Europe, Working Party on Xenotransplantation (CDBI/CDSP-XENO). Report of the state of the art of xenotransplantation. URL: <http://www.coe.fr/dase/en/qoflife/publi/artreport/tableart.htm>.

  14. United Kingdom Xenotransplantation Interim Regulatory Authority: Draft report of the Infection Surveillance Steering Group of the UKXIRA. URL: <http://www.doh.gov.uk/surveil.htm> last updated August 4, 1999; for other related documents, URL: <http://www.doh.gov.uk/ukxira.htm>.

  15. WHO. Xenotransplantation: guidance on infectious disease prevention and management WHO/EMC, (1998). URL: <http://www.who.int/emc-documents/
    zoonoses/whoemczoo981c.html    > and for listing see index at URL: <http://www.who.int/emc-documents/index.html>.

  16. Yoo D, Giulivi A. Xenotransplantation and the potential risk of porcine viruses for xenogeneic transmission. Can J Veterinary Res 2000;64:193-203.

  17. Labrique AB, Thomas DL, Stoszek SK et al. An emerging infectious disease. Epidemiol Rev 1999;21:162-79.

  18. Weiss RA, Griffiths D, Takeuchi Y et al. Retroviruses: ancient and modern. Arch Virol Suppl 1999;15:171-77.

  19. Patience C, Takeuchi Y, Weiss RA. Infection of human cells by an endogenous retrovirus of pigs. Nature Medicine 1997;3:282-86.

  20. Takeuchi Y, Patience C, Magre S et al. Host range and interference studies of three classes of pig endogenous retrovirus. J Virol 1998;72:9986-91.

  21. Denner J. Immunosuppression by retroviruses: implications for xenotransplantation. Ann NY Acad Sci 1998;862:75-86.

  22. Martin U, Kiessig V, Blusch JH et al. Expression of pig endogenous retrovirus by primary porcine endothelial cells and infection of human cells. Lancet 1998;352:692-94.

  23. Van Der Laan LJW, Lockey C, Griffeth BC et al. Infection by porcine endogenous retrovirus after islet xenotransplantation in SCID mice. Nature 2000;407:501-4.

  24. Tacke SJ, Kurth R, Denner J. Porcine endogenous retroviruses inhibit human immune cell function: risk for xenotransplantation? Virology 2000;268:87-93.

  25. Clemenceau B, Lalain S, Martignat L et al. Porcine endogenous retroviral mRNAs in pancreas and a panel of tissues from specific pathogen-free pigs. Diabetes Metab 1999;25:518-25.

  26. Paradis K, Langford G, Long Z et al. Search for cross-species transmission of porcine endogenous retrovirus in patients treated with living pig tissue. Science 1999;285:1236-41.

  27. Pitken Z, Mullon C. Evidence of absence of porcine endogneous retrovirus (PERV) infection in patients treated with a bioartificial liver support system. Artif Organs 1999;23:829-33.

  28. Switzer WM, Shanmugam V, Chapman et al. Polymerase chain reaction assays for the diagnosis of infection with the porcine endogenous retrovirus and the detection of pig cells in human and nonhuman recipients of pig xenografts. Transplantation 1999;68:183-88.

  29. Martin U, Steinhoff G. Porcine endogenous retroviruses (PERV): in vitro artifact or a big problem for xenotransplantation? DTW-Dtsch-Tierarztl-Wochenschr 1999;106:146-49.

  30. Patience C, Patton GS, Takeuchi Y et al. No evidence of pig DNA or retroviral infection in patients with short-term extracorporeal connection to pig kidneys. Lancet 1998;352:699-701.

  31. Heneine W, Tibell A, Switzer WM et al. No evidence of infection with porcine endogenous retrovirus in recipients of porcine islet-cell xenografts. Lancet 1998;352:695-98.

  32. Deacon T, Schumacher J, Dinsmore J et al. Histological evidence of fetal pig neural cell survival after transplantation into a patient with Parkinson's disease. Nature Medicine 1997;3:350-53.

  33. Patience C. Sessional report on xenotransplantation: potential for infection. The XVIII Meeting of the International Congress of the Transplantation Society, Rome, Italy, August 28, 2000.

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