| Citation: | Xenotransplantation Group in Branch of Organ Transplantation of Chinese Medical Association, Wang Wei, Dou Kefeng, et al. Experts consensus on islet xenotransplantation clinical trial (2019 expert advice edition)[J]. ORGAN TRANSPLANTATION, 2019, 10(6): 672-677. doi: 10.3969/j.issn.1674-7445.2019.06.007
|
| [1] |
COOPER DK, CASU A. The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes--chapter 4: pre-clinical efficacy and complication data required to justify a clinical trial[J]. Xenotransplantation, 2009, 16(4):229-238. DOI: 10.1111/j.1399-3089.2009.00543.x.
|
| [2] |
MATSUMOTO S, TAN P, BAKER J, et al. Clinical porcine islet xenotransplantation under comprehensive regulation[J]. Transplant Proc, 2014, 46(6):1992-1995. DOI: 10.1016/j.transproceed.2014.06.008.
|
| [3] |
COOPER DK, MATSUMOTO S, ABALOVICH A, et al. Progress in clinical encapsulated islet xenotransplantation[J]. Transplantation, 2016, 100(11):2301-2308. doi: 10.1097/TP.0000000000001371
|
| [4] |
U.S. Department of Health and Human Services Food and Drug Administration, Center for Biologics Evaluation and Research. Guidance for industry: source animal, product, preclinical, and clinical issues concerning the use of xenotransplantation products in humans[EB/OL]. (2016-12-01). https://www.fda.gov/media/102126/download.
|
| [5] |
LARIJANI B, ARJMAND B, AMOLI MM, et al. Establishing a cGMP pancreatic islet processing facility: the first experience in Iran[J]. Cell Tissue Bank, 2012, 13(4):569-575. DOI: 10.1007/s10561-011-9273-1.
|
| [6] |
Department of Health and Human Services Food and Drug Administration. PHS guideline on infectious disease issues in xenotransplantation[EB/OL]. (2019-06-30). https://www.fda.gov/media/73803/download.
|
| [7] |
FISHMAN JA, SCOBIE L, TAKEUCHI Y. Xenotransplantation-associated infectious risk: a WHO consultation[J]. Xenotransplantation, 2012, 19(2):72-81. DOI: 10.1111/j.1399-3089.2012.00693.x.
|
| [8] |
FISHMAN JA. Infectious disease risks in xenotransplantation[J]. Am J Transplant, 2018, 18(8): 1857-1864. DOI: 10.1111/ajt.14725.
|
| [9] |
YANG L, GÜELL M, NIU D, et al. Genome-wide inactivation of porcine endogenous retroviruses (PERVs)[J]. Science, 2015, 350(6264):1101-1104. DOI: 10.1126/science.aad1191.
|
| [10] |
Second WHO Global Consultation on Regulatory Requirements for Xenotransplantation Clinical Trials[EB/OL]. (2011-10-17).http://158.232.12.119/transplantation/xeno/report2nd_global_consultation_xtx.pdf.
|
| [11] |
World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects[J]. JAMA, 2013, 310(20):2191-2194. DOI: 10.1001/jama.2013.281053.
|
| [12] |
First WHO Global Consultation on Regulatory Requirements for Xenotransplantation Clinical Trials: Changsha, China, 19-21 November 2008. The Changsha Communiqué[J]. Xenotransplantation, 2009, 16(2):61-63. DOI: 10.1111/j.1399-3089.2009.00520.x.
|
| [13] |
HERING BJ, O' CONNELL PJ. First update of the International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes--Chapter 6: patient selection for pilot clinical trials of islet xenotransplantation[J]. Xenotransplantation, 2016, 23(1):60-76. DOI: 10.1111/xen.12228.
|
| [14] |
TUCH BE, KEOGH GW, WILLIAMS LJ, et al. Safety and viability of microencapsulated human islets transplanted into diabetic humans[J]. Diabetes Care, 2009, 32(10):1887-1889. DOI: 10.2337/dc09-0744.
|
| [15] |
GARKAVENKO O, CROXSON MC, IRGANG M, et al. Monitoring for presence of potentially xenotic viruses in recipients of pig islet xenotransplantation[J]. J Clin Microbiol, 2004, 42(11):5353-5356. doi: 10.1128/JCM.42.11.5353-5356.2004
|
| [16] |
PIERSON RN 3RD, DORLING A, AYARES D, et al. Current status of xenotransplantation and prospects for clinical application[J]. Xenotransplantation, 2009, 16(5):263-280. DOI: 10.1111/j.1399-3089.2009.00534.x.
|
| [17] |
SPIZZO T, DENNER J, GAZDA L, et al. First update of the International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes-- Chapter 2a: source pigs--preventing xenozoonoses[J]. Xenotransplantation, 2016, 23(1):25-31. DOI: 10.1111/xen.12223.
|
| [18] |
BOTTINO R, KNOLL MF, GRAEME-WILSON J, et al. Safe use of anti-CD154 monoclonal antibody in pig islet xenotransplantation in monkeys[J]. Xenotransplantation, 2017, 24(1). DOI: 10.1111/xen.12283.
|
| [19] |
SAMY KP, BUTLER JR, LI P, et al. The role of costimulation blockade in solid organ and islet xenotransplantation[J]. J Immunol Res, 2017:8415205. DOI: 10.1155/2017/8415205.
|
| [20] |
SCHWARZ C, MAHR B, MUCKENHUBER M, et al. Belatacept/CTLA4Ig: an update and critical appraisal of preclinical and clinical results[J]. Expert Rev Clin Immunol, 2018, 14(7):583-592. DOI: 10.1080/17446 66X.2018.1485489.
|
| [21] |
THOMSON AW, EZZELARAB MB. A tale of two pathways: renewing the promise of anti-CD40L blockade[J]. Am J Transplant, 2017, 17(5):1156-1157. DOI: 10.1111/ajt.14217.
|
| [22] |
WYNYARD S, NATHU D, GARKAVENKO O, et al. Microbiological safety of the first clinical pig islet xenotransplantation trial in New Zealand[J]. Xenotransplantation, 2014, 21(4):309-323. DOI: 10.1111/xen.12102.
|
| [23] |
KOURTZELIS I, MAGNUSSON PU, KOTLABOVA K, et al. Regulation of instant blood mediated inflammatory reaction (IBMIR) in pancreatic islet xeno-transplantation: points for therapeutic interventions[M]// LAMBRIS J, EKDAHL K, RICKLIN D, et al. Immune responses to biosurfaces. advances in experimental medicine and biology. Berlin: Springer, Cham, 2015: 865.
|
| [24] |
HAWTHORNE WJ, COWAN PJ, BÜHLER LH, et al. Third WHO Global Consultation on Regulatory Requirements for Xenotransplantation Clinical Trials, Changsha, Hunan, China December 12-14, 2018: "The 2018 Changsha Communiqué" The 10-Year Anniversary of The International Consultation on Xenotransplantation[J]. Xenotransplantation, 2019, 26(2):e12513. DOI:10. 1111/xen.12513.
|
| [25] |
SHIN TH, BAEK EJ, CORAT MAF, et al. CRISPR/Cas9 PIG -A gene editing in nonhuman primate model demonstrates no intrinsic clonal expansion of PNH HSPCs[J]. Blood, 2019, 133(23):2542-2545. DOI: 10.1182/blood.2019000800.
|
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