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Sponsored by: |
University Hospital, Grenoble |
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Information provided by: | University Hospital, Grenoble |
ClinicalTrials.gov Identifier: | NCT00639600 |
This research project is supported by a multicentric network of collaborators whose goal is to assess the efficacy of transplanting allogenic pancreas islets to restore insulin secretion in patients with type 1, insulin-dependent diabetes mellitus with kidney transplantation and to improve their metabolic control.
Condition | Intervention | Phase |
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Type 1 Diabetes Mellitus |
Procedure: human pancreatic islet transplantation |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Transplantation d'îlots pancréatiques allogéniques Adultes Pour le Traitement du diabète insulinodépendant. Etude GRAGIL 1. |
Estimated Enrollment: | 21 |
Study Start Date: | July 2003 |
Estimated Study Completion Date: | July 2008 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
The main objective is to demonstrate the beneficial effect of islet allotransplantation in patients with type 1 diabetes with no endogenous insulin secretion, and with a functional kidney graft. The other objectives are to evaluate the conditions for the efficacy of islet cell transplantation, to assess the improvement in quality of life and the cost of the islet cell transplantation.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria that are specific to the use of Rapamycine
Contact: Pierre Y Benhamou | + 33 476769349 | PYBenhamou@chu-grenoble.fr |
France | |
University Hospital, Department of Endocrinology | Recruiting |
Grenoble, France, 38043 | |
Contact: Pierre Y Benhamou + 33 476769349 PYBenhamou@chu-grenoble.fr | |
Principal Investigator: Pierre Y Benhamou, MD, PhD, Pr | |
Sub-Investigator: François Bayle, PhD | |
Sub-Investigator: Jean L Descotes, Pr | |
University Hospital, Department of Endocrinology | Recruiting |
Lyon, France, 69000 | |
Sub-Investigator: Charles Thivolet, Pr | |
Sub-Investigator: Emmanuel Morelon, Pr | |
Sub-Investigator: Xavier Martin, Pr | |
Sub-Investigator: Lionel Badet, Pr | |
University Hospital | Recruiting |
Besancon, France, 25000 | |
Sub-Investigator: Alfred Penfornis, Pr | |
Sub-Investigator: Jean M Chalopin, Pr | |
University Hospital, Department of Endocrinology | Recruiting |
Strasbourg, France, 66000 | |
Sub-Investigator: Michel Pinget, Pr | |
Sub-Investigator: Laurence Kessler, Pr | |
Sub-Investigator: Bruno Moulin, Pr | |
Sub-Investigator: Philippe Wolf, Pr | |
University Hospital, Department of Endocrinology | Recruiting |
Nancy, France, 54000 | |
Sub-Investigator: Luc Frimat, Pr | |
Sub-Investigator: Bruno Guerci, Pr | |
University Hospital, Department of Endocrinology | Recruiting |
Montpellier, France, 34000 | |
Sub-Investigator: Eric Renard, Pr | |
Sub-Investigator: Georges Mourad, Pr | |
Switzerland | |
University Hospital, Department of Surgery | Recruiting |
Geneva, Switzerland, 1211 | |
Sub-Investigator: Philippe Morel, Pr | |
Sub-Investigator: Thierry Berney, PhD | |
Sub-Investigator: Jacques Philippe, Pr |
Principal Investigator: | Pierre Y Benhamou, MD, PhD | University Hospital of Grenoble, Department of Endocrinology |
Responsible Party: | University Hospital, Grenoble ( Pierre-Yves Benhamou ) |
Study ID Numbers: | 95/CHUG/10/C2 |
Study First Received: | March 14, 2008 |
Last Updated: | March 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00639600 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
Immune System Diseases |