Five-year metabolic, functional, and safety results of patients with type 1 diabetes transplanted with allogenic islets within the Swiss-French GRAGIL network

Diabetes Care

Volumn 38, Issue 9, 2015, Pages 1714-1722

  Lablanche, Sandrine ^a   Borot, Sophie ^b   Wojtusciszyn, Anne ^c   Bayle, Francois ^a   Tetaz, Rachel ^a   Badet, Lionel ^d   Thivolet, Charles ^d   Morelon, Emmanuel ^d   Frimat, Luc ^e   Penfornis, Alfred ^f   Kessler, Laurence ^g   Brault, Coralie ^d   Colin, Cyrille ^d   Tauveron, Igor ^h   Bosco, Domenico ⁱ   Berney, Thierry ⁱ   Benhamou, Pierre Yves ^a  

^a GRENOBLE UNIVERSITY HOSPITAL   (France)

^b UNIVERSITY HOSPITAL JEAN MINJOZ   (France)

^c MONTPELLIER UNIVERSITY HOSPITAL   (France)

^d HOSPICES CIVILS DE LYON   (France)

^e UNIVERSITY HOSPITAL OF NANCY   (France)

^f CENTRE HOSPITALIER SUD FRANCILIEN   (France)

^g UNIVERSITY HOSPITAL OF STRASBOURG   (France)

^h UNIVERSITÉ CLERMONT AUVERGNE   (France)

ⁱ GENEVA UNIVERSITY HOSPITALS   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

C PEPTIDE; CREATININE; HEMOGLOBIN A1C; INSULIN; GLUCOSE BLOOD LEVEL;

ADULT; ALLOTRANSPLANTATION; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL (TOPIC); COHORT ANALYSIS; CONTROLLED STUDY; CREATININE CLEARANCE; CYTOLYSIS; FEMALE; FOLLOW UP; GENERAL ASPECTS OF DISEASE; GRAFT FUNCTION; GRAFT RECIPIENT; GRAFT SURVIVAL; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPOGLYCEMIA; IMMUNOSUPPRESSIVE TREATMENT; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN INDEPENDENCE; ISLET AFTER KIDNEY TRANSPLANTATION; ISLET MASS; LENGTH OF STAY; MALE; MEDICAL PARAMETERS; METABOLIC REGULATION; MULTICENTER STUDY (TOPIC); OUTCOME ASSESSMENT; PANCREAS ISLET TRANSPLANTATION; PARAMETERS; PATIENT SAFETY; PORTAL VEIN THROMBOSIS; POSTOPERATIVE HEMORRHAGE; RETROSPECTIVE STUDY; RISK BENEFIT ANALYSIS; TRANSPLANTATION; CLINICAL TRIAL; DIABETES MELLITUS, TYPE 1; FRANCE; GLUCOSE BLOOD LEVEL; KIDNEY TRANSPLANTATION; METABOLISM; MIDDLE AGED; PROCEDURES; SAFETY; SWITZERLAND; TREATMENT OUTCOME;

ADULT; BLOOD GLUCOSE; DIABETES MELLITUS, TYPE 1; FEMALE; FOLLOW-UP STUDIES; FRANCE; HUMANS; ISLETS OF LANGERHANS TRANSPLANTATION; KIDNEY TRANSPLANTATION; MALE; MIDDLE AGED; RETROSPECTIVE STUDIES; SAFETY; SWITZERLAND; TREATMENT OUTCOME;

EID: 84962343530     PISSN: 01495992     EISSN: 19355548     Source Type: Journal    
DOI: 10.2337/dc15-0094     Document Type: Article

References (38)

1. Fiorina P, Folli F, Zerbini G, et al. Islet transplantation is associated with improvement of renal function among uremic patients with type I diabetes mellitus and kidney transplants. J Am Soc Nephrol 2003;14:2150-2158.
2. Shapiro AM, Lakey JR, Ryan EA, et al. Islet transplantation in seven patients with type 1 diabetes mellitus using a glucocorticoid-free immunosuppressive regimen. N Engl J Med 2000; 343:230-238.
3. Linetsky E, Bottino R, Lehmann R, Alejandro R, Inverardi L, Ricordi C. Improved human islet isolation using a new enzyme blend, liberase. Diabetes 1997;46:1120-1123.
4. Barton FB, Rickels MR, Alejandro R, et al. Improvement in outcomes of clinical islet transplantation: 1999-2010. Diabetes Care 2012;35: 1436-1445.
5. Bellin MD, Kandaswamy R, Parkey J, et al. Prolonged insulin independence after islet allotransplants in recipients with type 1 diabetes. Am J Transplant 2008;8:2463-2470.
6. Bellin MD, Barton FB, Heitman A, et al. Potent induction immunotherapy promotes long-term insulin independence after islet transplantation in type 1 diabetes. Am J Transplant 2012;12:1576-1583.
7. Benhamou PY, Milliat-Guittard L, Wojtusciszyn A, et al.; GRAGIL group. Quality of life after islet transplantation: data from the GRAGIL 1 and 2 trials. Diabet Med 2009;26:617-621.
8. Leitão CB, Tharavanij T, Cure P, et al. Restoration of hypoglycemia awareness after islet transplantation. Diabetes Care 2008;31:2113-2115.
9. Warnock GL, Thompson DM, Meloche RM, et al. A multi-year analysis of islet transplantation compared with intensive medical therapy on progression of complications in type 1 diabetes. Transplantation 2008;86:1762-1766.
10. Thompson DM, Meloche M, Ao Z, et al. Reduced progression of diabetic microvascular complications with islet cell transplantation compared with intensive medical therapy. Transplantation 2011;91:373-378.
11. Benhamou PY, Oberholzer J, Toso C, et al.; GRAGIL consortium. Human islet transplantation network for the treatment of type I diabetes: first data from the Swiss-French GRAGIL consortium (1999-2000). Groupe de Recherche Rhin Rhjne Alpes Geǹeve pour la transplantation d'Ilots de Langerhans. Diabetologia 2001; 44:859-864.
12. Badet L, Benhamou PY, Wojtusciszyn A, et al.; GRAGIL Group. Expectations and strategies regarding islet transplantation: metabolic data from the GRAGIL 2 trial. Transplantation 2007;84:89-96.
13. Borot S, Niclauss N, Wojtusciszyn A, et al.; GRAGIL Network. Impact of the number of infusions on 2-year results of islet-after-kidney transplantation in the GRAGIL network. Transplantation 2011;92:1031-1038.
14. Kempf MC, Andres A, Morel P, et al.; GRAGIL group. Logistics and transplant coordination activity in the GRAGIL Swiss-French multicenter network of islet transplantation. Transplantation 2005; 79:1200-1205.
15. Ricordi C, Lacy PE, Finke EH, Olack BJ, Scharp DW. Automated method for isolation of human pancreatic islets. Diabetes 1988;37: 413-420.
16. Brons G. One more step along the road. Transplantation 2007;84:15-16.
17. Toso C, Baertschiger R, Morel P, et al.;GRAGIL Group. Sequential kidney/islet transplantation: efficacy and safety assessment of a steroid-free immunosuppression protocol. Am J Transplant 2006;6:1049-1058.
18. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Guideline for IndustrydClinical Safety Data Management: Definitions and Standards for Expedited Reporting. Brussels, Belgium, ICH, 2007.
19. Ryan EA, Paty BW, Senior PA, Lakey JR, Bigam D, Shapiro AM. Beta-score: An assessment of b-cell function after islet transplantation. Diabetes Care 2005;28:343-347.
20. Caumo A, Maffi P, Nano R, et al. Transplant estimated function: A simple index to evaluate b-cell secretion after islet transplantation. Diabetes Care 2008;31:301-305.
21. Vantyghem MC, Kerr-Conte J, Arnalsteen L, et al. Primary graft function, metabolic control, and graft survival after islet transplantation. Diabetes Care 2009;32:1473-1478.
22. Vantyghem MC, Raverdy V, Balavoine AS, et al. Continuous glucose monitoring after islet transplantation in type 1 diabetes: An excellent graft function (b-score greater than 7) is required to abrogate hyperglycemia, whereas a minimal function is necessary to suppress severe hypoglycemia (b-score greater than 3). J Clin Endocrinol Metab 2012;97: E2078-E2083.
23. Ryan EA, Paty BW, Senior PA, et al. Five-year follow-up after clinical islet transplantation. Diabetes 2005;54:2060-2069.
24. Ryan EA, Lakey JR, Paty BW, et al. Successful islet transplantation: continued insulin reserve provides long-term glycemic control. Diabetes 2002;51:2148-2157.
25. Shapiro AM, Ricordi C, Hering BJ, et al. International trial of the Edmonton protocol for islet transplantation. N Engl J Med 2006;355: 1318-1330.
26. Niclauss N, Bosco D, Morel P, et al. Influence of donor age on islet isolation and transplantation outcome. Transplantation 2011;91: 360-366.
27. Caiazzo R, Gmyr V, Kremer B, et al. Quantitative in vivo islet potency assay in normoglycemic nude mice correlates with primary graft function after clinical transplantation. Transplantation 2008;86:360-363.
28. Ichii H, Pileggi A, Molano RD, et al. Rescue purification maximizes the use of human islet preparations for transplantation. Am J Transplant 2005;5:21-30.
29. Food and Drug Administration. Guideline for industrydclinical safety data management: definitions and standards for expedited reporting [article online], 1995. Available from http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073087.pdf Accessed March 1995.
30. Lehmann R, Spinas GA, Moritz W, Weber M. Has time come for new goals in human islet transplantation? Am J Transplant 2008;8: 1096-1100.
31. Tanenberg RJ, Newton CA, Drake AJ. Confirmation of hypoglycemia in the "dead-in-bed" syndrome, as captured by a retrospective continuous glucose monitoring system. Endocr Pract 2010;16:244-248.
32. McCoy RG, Van Houten HK, Ziegenfuss JY, Shah ND, Wermers RA, Smith SA. Increased mortality of patients with diabetes reporting severe hypoglycemia. Diabetes Care 2012;35: 1897-1901.
33. Retinopathy and nephropathy in patients with type 1 diabetes four years after a trial of intensive therapy. Am J Ophthalmol 2000;129: 704-705.
34. Collaborative Islet Transplant Registry (CITR). Seventh annual report [article online], 2011. Available from http://www.citregistry.org/. Accessed 30 December 2011.
35. Gruessner RW, Gruessner AC. The current state of pancreas transplantation. Nat Rev Endocrinol 2013;9:555-562.
36. Kawahara T, Kin T, Kashkoush S, et al. Portal vein thrombosis is a potentially preventable complication in clinical islet transplantation. Am J Transplant 2011;11:2700-2707.
37. Bucher P, Mathe Z, Bosco D, et al. Morbidity associated with intraportal islet transplantation. Transplant Proc 2004;36:1119-1120.
38. Guignard AP, Oberholzer J, Benhamou PY, et al.; GRAGIL Group. Cost analysis of human islet transplantation for the treatment of type 1 diabetes in the Swiss-French Consortium GRAGIL. Diabetes Care 2004;27:895-900.