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Master Thesis

Évaluation de la sécurité de la transplantation d’îlots pancréatiques allogéniques chez les patients diabétiques de type 1

Abstract : Islet transplantation is a promising alternative for the treatment of type 1 diabetes. This therapy, proposed to patient after after kidney transplantation or with unstable glycemic control, allows to obtain a 3-year insulinindependance rate of 44% and an improvement of health quality. Procedure related complication (hemorrhage, portal vein thrombosis) and immunosuppressive (IS) therapy related complication (infections, cancer) could be observed. The aim of this study is to analyze the safety profile of islet transplantation in a phase II trial, from April 25th 2010 to may 31st 2016. On the 46 patients included, 45 received islet transplantation leading to 112 infusions. All in all, 83% of patient presented at least a serious adverse event (SAE). 6 graft rejection were notified. Complications were observed for 12 out of 112 islet infusions (10.7%), mainly 4 hemorrhages. The majority of SAEs were related to the IS therapy (42.5%) with blood disorders, gastrointestinal disorders and infections. The reassuring safety data are conformed with the literature. No risk factor was identified, excepted the risk of insulin neuritis and arrhythmias. This study concluded that the IS therapy induced the largest provider of serious adverse events at the time of islet transplantation, encouraging to develop alternative to IS agents and to the intraportal islet transplantation.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-01564697
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Submitted on : Wednesday, July 19, 2017 - 10:18:26 AM
Last modification on : Wednesday, July 15, 2020 - 8:56:03 AM

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  • HAL Id : dumas-01564697, version 1

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Constance Minebois. Évaluation de la sécurité de la transplantation d’îlots pancréatiques allogéniques chez les patients diabétiques de type 1. Sciences pharmaceutiques. 2016. ⟨dumas-01564697⟩

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