Sandrine Lablanche1, Sophie Borot2, Anne Wojtusciszyn3, Francois Bayle4, Rachel Tétaz4, Lionel Badet5, Charles Thivolet6, Emmanuel Morelon7, Luc Frimat8, Alfred Penfornis9, Laurence Kessler10, Coralie Brault11, Cyrille Colin11, Igor Tauveron12, Domenico Bosco13, Thierry Berney13, Pierre-Yves Benhamou14. 1. Department of Endocrinology, Pôle DigiDune, Grenoble University Hospital, Joseph Fourier University, Grenoble, France slablanche@chu-grenoble.fr. 2. Centre Hospitalier Universitaire Jean Minjoz, Service d'Endocrinologie-Métabolisme et Diabétologie-Nutrition, Besançon, France. 3. Centre Hospitalier de Montpellier, Pôle Rein Hypertension Métabolisme, Service d'Endocrinologie, Montpellier, France. 4. Department of Nephrology, Pôle DigiDune, Grenoble University Hospital, Joseph Fourier University, Grenoble, France. 5. Hospices Civils de Lyon, Service d'Urologie et de Chirurgie de la Transplantation, Pôle Chirurgie, Lyon, France. 6. Hospices Civils de Lyon, Service d'Endocrinologie Diabète Nutrition, Lyon, France. 7. Hospices Civils de Lyon, Service de Néphrologie Médecine de la Transplantation et Immunologie Clinique, Lyon, France. 8. Centre Hospitalier Universitaire de Nancy, Service de Néphrologie, Nancy, France. 9. Service d'Endocrinologie, Diabétologie et Maladies Métaboliques, Centre Hospitalier Sud-Francilien, Corbeil-Essonnes, France. 10. Hôpitaux Universitaires de Strasbourg, Service d'Endocrinologie Diabète et Maladies Métaboliques, Pôle NUDE, Strasbourg, France. 11. Hospices Civils de Lyon, Pôle Information Médicale Evaluation Recherche, and Université de Lyon, EA Santé-Individu-Société 4129, Lyon, France. 12. CHU de Clermont-Ferrand, Service Endocrinologie-Diabète-Maladies Métaboliques, Clermont Ferrand Université, Clermont-Ferrand, France. 13. Departement of Surgery, Islet Isolation, and Transplantation Center, Geneva University Hospitals, Geneva, Switzerland. 14. Department of Endocrinology, Pôle DigiDune, Grenoble University Hospital, Joseph Fourier University, Grenoble, France.
Abstract
OBJECTIVE: To describe the 5-year outcomes of islet transplantation within the Swiss-French GRAGIL Network. RESEARCH DESIGN AND METHODS: Retrospective analysis of all subjects enrolled in the GRAGIL-1c and GRAGIL-2 islet transplantation trials. Parameters related to metabolic control, graft function, and safety outcomes were studied. RESULTS: Forty-four patients received islet transplantation (islet transplantation alone [ITA] 24 patients [54.5%], islet after kidney [IAK] transplantation 20 patients [45.5%]) between September 2003 and April 2010. Recipients received a total islet mass of 9,715.75 ± 3,444.40 IEQ/kg. Thirty-four patients completed a 5-year follow-up, and 10 patients completed a 4-year follow-up. At 1, 4, and 5 years after islet transplantation, respectively, 83%, 67%, and 58% of the ITA recipients and 80%, 70%, and 60% of the IAK transplant recipients reached HbA1c under 7% (53 mmol/mol) and were free of severe hypoglycemia, while none of the ITA recipients and only 10% of the IAK transplant recipients met this composite criterion at the preinfusion stage. Thirty-three of 44 patients (75%) experienced insulin independence during the entire follow-up period, with a median duration of insulin independence of 19.25 months (interquartile range 2-58). Twenty-nine of 44 recipients (66%) exhibited at least one adverse event; 18 of 55 adverse events (33%) were possibly related to immunosuppression; and complications related to the islet infusion (n = 84) occurred in 10 recipients (11.9%). CONCLUSIONS: In a large cohort with a 5-year follow-up and in a multicenter network setting, islet transplantation was safe and efficient in restoring good and lasting glycemic control and preventing severe hypoglycemia in patients with type 1 diabetes.
OBJECTIVE: To describe the 5-year outcomes of islet transplantation within the Swiss-French GRAGIL Network. RESEARCH DESIGN AND METHODS: Retrospective analysis of all subjects enrolled in the GRAGIL-1c and GRAGIL-2 islet transplantation trials. Parameters related to metabolic control, graft function, and safety outcomes were studied. RESULTS: Forty-four patients received islet transplantation (islet transplantation alone [ITA] 24 patients [54.5%], islet after kidney [IAK] transplantation 20 patients [45.5%]) between September 2003 and April 2010. Recipients received a total islet mass of 9,715.75 ± 3,444.40 IEQ/kg. Thirty-four patients completed a 5-year follow-up, and 10 patients completed a 4-year follow-up. At 1, 4, and 5 years after islet transplantation, respectively, 83%, 67%, and 58% of the ITA recipients and 80%, 70%, and 60% of the IAK transplant recipients reached HbA1c under 7% (53 mmol/mol) and were free of severe hypoglycemia, while none of the ITA recipients and only 10% of the IAK transplant recipients met this composite criterion at the preinfusion stage. Thirty-three of 44 patients (75%) experienced insulin independence during the entire follow-up period, with a median duration of insulin independence of 19.25 months (interquartile range 2-58). Twenty-nine of 44 recipients (66%) exhibited at least one adverse event; 18 of 55 adverse events (33%) were possibly related to immunosuppression; and complications related to the islet infusion (n = 84) occurred in 10 recipients (11.9%). CONCLUSIONS: In a large cohort with a 5-year follow-up and in a multicenter network setting, islet transplantation was safe and efficient in restoring good and lasting glycemic control and preventing severe hypoglycemia in patients with type 1 diabetes.
Authors: Barbora Voglová; Martina Zahradnická; Peter Girman; Jan Kríž; Zuzana Berková; Tomáš Koblas; Ema Vávrová; Lenka Németová; Lucie Kosinová; David Habart; Eva Fábryová; Eva Dovolilová; Ivan Leontovyc; Tomáš Neškudla; Jan Peregrin; Jozef Kovác; Kvetoslav Lipár; Matej Kocík; Tomáš Marada; Jirí Svoboda; František Saudek Journal: Rev Diabet Stud Date: 2017-06-12
Authors: S A Wisel; J M Gardner; G R Roll; J Harbell; C E Freise; S Feng; S M Kang; R Hirose; D B Kaufman; A M Posselt; P G Stock Journal: Am J Transplant Date: 2017-06-06 Impact factor: 8.086
Authors: Ashley Pinckney; Mark R Rigby; Lynette Keyes-Elstein; Carol L Soppe; Gerald T Nepom; Mario R Ehlers Journal: Clin Ther Date: 2016-05-18 Impact factor: 3.393