First update of the International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes - Chapter 1: Update on national regulatory frameworks pertinent to clinical islet xenotransplantation

Xenotransplantation

Volumn 23, Issue 1, 2016, Pages 14-24

  Cozzi, Emanuele ^a,b   Tönjes, Ralf R ^c   Gianello, Pierre ^d   Bühler, Léo H ^e   Rayat, Gina R ^f   Matsumoto, Shinichi ^g   Park, Chung Gyu ^h   Kwon, Ivo ^h   Wang, Wei ⁱ   O'Connell, Philip ^j   Jessamine, Stewart ^k   Elliott, Robert B ^l   Kobayashi, Takaaki ^m   Hering, Bernhard J ⁿ  

^a UNIVERSITY HOSPITAL OF PADOVA   (Italy)

^b CORIT ^*  (Italy)

^c PAUL EHRLICH INSTITUT   (Germany)

^d UNIVERSITÉ CATHOLIQUE DE LOUVAIN   (Belgium)

^e GENEVA UNIVERSITY HOSPITALS   (Switzerland)

^f UNIVERSITY OF ALBERTA   (Canada)

^g OTSUKA PHARMACEUTICAL CO LTD   (Japan)

^h Seoul National University   (South Korea)

ⁱ CENTRAL SOUTH UNIVERSITY   (China)

^j UNIVERSITY OF SYDNEY   (Australia)

^k Medsafe New Zealand   (New Zealand)

^l Diatranz Ltd   (New Zealand)

^m AICHI MEDICAL UNIVERSITY SCHOOL OF MEDICINE   (Japan)

ⁿ UNIVERSITY OF MINNESOTA MEDICAL SCHOOL   (United States)

more..

Author keywords

national regulatory frameworks; type 1 diabetes; xenotransplantation

Indexed keywords

AUSTRALIA; CONSENSUS; CONTROLLED STUDY; DIABETIC PATIENT; EUROPEAN UNION; GEOGRAPHY; HUMAN; INSULIN DEPENDENT DIABETES MELLITUS; NEW ZEALAND; PANCREAS ISLET BETA CELL; PRIORITY JOURNAL; PUBLIC HEALTH; RECIPIENT; REVIEW; SAFETY; XENOTRANSPLANTATION; ANIMAL; CLINICAL TRIAL (TOPIC); CONSENSUS DEVELOPMENT; DIABETES MELLITUS, TYPE 1; ETHICS; INFORMED CONSENT; LEGISLATION AND JURISPRUDENCE; PANCREAS ISLET TRANSPLANTATION; PATIENT SELECTION; PIG; PROCEDURES; XENOGRAFT;

ANIMALS; CLINICAL TRIALS AS TOPIC; DIABETES MELLITUS, TYPE 1; HUMANS; INFORMED CONSENT; ISLETS OF LANGERHANS TRANSPLANTATION; PATIENT SELECTION; SWINE; TRANSPLANTATION, HETEROLOGOUS;

EID: 84960800955     PISSN: 0908665X     EISSN: 13993089     Source Type: Journal    
DOI: 10.1111/xen.12222     Document Type: Review

References (39)

1. Samy KP, Martin BM, Turgeon NA, Kirk AD,. Islet cell xenotransplantation: A serious look toward the clinic. Xenotransplantation 2014; 21: 221-229.
2. van der Windt D.J, Bottino R, Casu A, Campanile N, Smetanka S, He J, et al., Long-term controlled normoglycemia in diabetic non-human primates after transplantation with hCD46 transgenic porcine islets. Am J Transplant 2009; 9: 2716-2726.
3. Shin JS, Kim JM, Kim JS, Min BH, Kim YH, et al., Long-Term Control of Diabetes in Immunosuppressed Nonhuman Primates (NHP) by the Transplantation of Adult Porcine Islets. Am J Transplant 2015; 15: 2837-2850.
4. Available at: Www.lctglobal.com.
5. Cozzi E, Tallacchini M, Flanagan EB, Pierson RN 3rd, Sykes M, Vanderpool HY,. The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes-chapter 1: Key ethical requirements and progress toward the definition of an international regulatory framework. Xenotransplantation 2009; 16: 203-214.
6. Fishman JA,. Infection in solid-organ transplant recipients. N Engl J Med 2007; 20: 357.
7. Palacios G, Druce J, Du L, Tran T, Birch C, et al., A new arenavirus in a cluster of fatal transplant-associated diseases. N Engl J Med 2008; 6: 358.
8. Available at http://www.ema.europa.eu/ema/pages/includes/document/open-document.jsp?webContentId=WC500003832.
9. Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on Advanced Therapy Medicinal Products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004. Available at: Http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:324:0121:0137:en:PDF [accessed on 8 February 2015].
10. 810.21. Federal Act on the Transplantation of Organs, Tissues and Cells. Available at: Http://www.admin.ch/ch/e/rs/810-21/index.html [accessed on 8 February 2015].
11. 810.211. Verordnung über die Transplantation von menschlichen Organen, Geweben und Zellen. Available at: Http://www.admin.ch/opc/de/classified-compilation/20051806/index.html. (This document is only available in german, french and italian language). [accessed on 8 February 2015].
12. 810.213. Verordnung über die Transplantation von tierischen Organen, Geweben und Zellen. Available at: Http://www.admin.ch/opc/de/classified-compilation/20051808/index.html. (This document is only available in german, french and italian language) [accessed on 8 February 2015].
13. I nternational Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Available at: Http://www.ich.org/home.html [accessed on 8 February 2015].
14. M4: The Common Technical Document. Available at: Http://www.ich.org/products/ctd.html [accessed on 8 February 2015].
15. Guidance for Industry 187, "Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs"; Available at: Http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM113903.pdf.
16. Arcidiacono JA, Evdokimov E, Lee MH, Jones J, Rudenko L, Schneider B, Snoy PJ, Wei CH, Wensky AK, Wonnacott K,. Regulation of xenogeneic porcine pancreatic islets. Xenotransplantation 2010; 17: 329-337.
17. Available at: Http://laws-lois.justice.gc.ca/eng/acts/F-27/page-1.html.
18. Available at: Http://laws-lois.justice.gc.ca/PDF/F-27.pdf.
19. Available at: Http://laws-lois.justice.gc.ca/eng/regulations/C.R.C.%2C-c.-870/.
20. Available at: Http://laws-lois.justice.gc.ca/PDF/C.R.C.,-c.-870.pdf.
21. Available at: Http://laws-lois.justice.gc.ca/eng/regulations/sor-98-282/.
22. Available at: Http://laws-lois.justice.gc.ca/PDF/SOR-98-282.pdf.
23. Available at: Http://www.hc-sc.gc.ca/dhp-mps/brgtherap/index-eng.php.
24. Available at: Http://www.hc-sc.gc.ca/dhp-mps/md-im/legislation/index-eng.php.
25. Available at: Http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/fs-fi/xeno-fact-fait-eng.php.
26. P roposed Canadian Standard for Xenotransplantation (Health Canada, July 1999). All reference materials (except 26) were accessed online on February 2, 2015.
27. Available at: Http://www.mhlw.go.jp/english/policy/health-medical/medical-care/.
28. Available at: Http://www.mhlw.go.jp/english/policy/health-medical/medical-care/dl/150407-01.pdf.
29. "Guide for the Scope of Xenografts and Source Animals"; Available at: Http://www.mfds.go.kr/index.do?mid=689&pageNo=95&cmd=v&seq=4664.
30. "Guide for the Quality Control and Infection Management of Xenografts"; Available at: Http://www.mfds.go.kr/index.do?mid=689&pageNo=95&cmd=v&seq=4665.
31. "Guide for the Preclinical and Clinical Trials of Xenografts"; Available at: Http://www.mfds.go.kr/index.do?mid=689&pageNo=95&cmd=v&seq=4666.
32. Available at: Http://www.who.int/transplantation/xeno/ChangshaCommunique.pdf?ua=1.
33. Available at: Http://www.chinadaily.com.cn/m/chinahealth/2014-06/05/content-17566177.htm.
34. Xenotransplantation: A review of the parameters, risks and benefits. National Health and Medical Research Council of Australia, 2009.
35. Available at: Https://www.tga.gov.au/publication/australian-regulatory-guidelines-biologicals-argb.
36. Matsumoto S, Tan P, Baker J, Durbin K, Tomiya M, Azuma K, Doi M, Elliott RB,. Clinical porcine islet xenotransplantation under comprehensive regulation. Transplant Proc 2014; 46: 1992-1995.
37. Garkavenko O, Dieckhoff B, Wynyard S, Denner J, Elliott RB, Tan PL, Croxson MJ,. Absence of transmission of potentially xenotic viruses in a prospective pig to primate islet xenotransplantation study. Med Virol. 2008; 80: 2046-2052.
38. Available at: Http://www.who.int/transplantation/xeno/report2nd-global-consultation-xtx.pdf.
39. Fishman JA, Scobie L, Takeuchi Y,. Xenotransplantation-associated infectious risk: A WHO consultation. Xenotransplantation 2012; 19: 72-81.