Allogeneic Islet Transplantation for the Treatment of Type 1 Diabetes (GRIIF)
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|ClinicalTrials.gov Identifier: NCT01974674|
Recruitment Status : Recruiting
First Posted : November 1, 2013
Last Update Posted : September 29, 2016
It is a multicentre, sequential, phase II clinical trial, aiming at evaluating the allogeneic islet transplantation for the treatment of type 1 diabetes.
19 patients with type 1 diabetes will be included and ideally distributed evenly: patients with unstable diabetes without renal insufficiency (AI group for "islet alone" by the international customary determination) and patients with a functioning kidney transplant (IAK group for "islet after kidney"). The main endpoint will be defined by the restoration of normal glycemic control without insulin at 6 months after graft.
|Condition or disease||Intervention/treatment||Phase|
|Patients With Type 1 Diabetes||Procedure: Allogeneic transplantation of intrahepatic islet||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Allogeneic Islet Transplantation for the Treatment of Type 1 Diabetes|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||January 2022|
Experimental: Allogeneic transplantation of intrahepatic islet
Allogeneic transplantation of intrahepatic islet number required for insulin independence of obtaining, with a threshold dose of 9,000 IEQ/kg body weight of the recipient and a maximum sequence number of 3 infusions. The patient will receive after transplantation immunosuppressive therapy with Thymoglobulin for induction, Prograf and Cellcept, both of which are given throughout the duration of the study
|Procedure: Allogeneic transplantation of intrahepatic islet|
- restoration of normal glycemic control without insulin [ Time Frame: 6 months after graft ]
the restoration of normal glycemic control without insulin therapy will be evaluated by measuring
- A fasting glucose (> 8 hours) less than 1.25 g/L and a 2 hours glucose after oral intake of 75g of glucose, less than 2 g/L in a patient without insulin for at least 15 consecutive days during the the first 6 months from day 0.
- Restoration of normal glycemic control without insulin for a year [ Time Frame: 1 year ]
- Obtaining an improvement in glycemic control [ Time Frame: within 2 years after inclusion ]HbA1c <6.5%, with lower insulin doses by 30%
- Obtaining a remission of diabetes [ Time Frame: within 2 years after inclusion ]
The remission of diabetes is defined by the normality of blood glucose or insulin without lHbA1c.
The normality of blood glucose is defined below 1.20 g/L and postprandial fasting glycemia less than 1.60 g/L in the book self-monitoring (including 6/7 blood glucoses during the previous 3 days evaluation visit).
Normal HbA1c is defined as less than 6.5%.
- Improved metabolic profile determined by the OGTT and hyperglycemic clamp [ Time Frame: within 2 years after inclusion ]
- Decreased glycemic variability [ Time Frame: within 2 years after inclusion ]defined on blood glucose and / or glucose holter
- Reduction of oxidative stress assessed by the urinary excretion of 24 hours of 8-iso-PGF2 rates. [ Time Frame: within 2 years after inclusion ]
- Decrease in the frequency, severity or poor perception of hypoglycaemia defined Hypo score [ Time Frame: within the 2 years after inclusion ]
- quality of life [ Time Frame: within 2 years after inclusion ]defined by questionnaires DQOL and SF-36
- term graft survival [ Time Frame: within 2 years of inclusion ]defined by the rate of C-peptide
- beta-cell function [ Time Frame: 2 years ]based on beta-score
- potential of each infusion of islets [ Time Frame: within 2 years after inclusion ]number of IEQ/kg of recipient required to reduce the daily insulin dose of 1 unit
- degenerative complications of diabetes [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01974674
|Contact: Pierre CATTAN, MD PhD||33 1 firstname.lastname@example.org|
|Saint Louis hospital||Recruiting|
|Paris, Ile de France, France, 75010|
|Contact: Pierre CATTAN, MD PhD 33 1 42494786 email@example.com|