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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01974674
|Contact: Pierre CATTAN, MD PhD||33 1 email@example.com|
|Saint Louis hospital||Recruiting|
|Paris, Ile de France, France, 75010|
|Contact: Pierre CATTAN, MD PhD 33 1 42494786 firstname.lastname@example.org|