Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321256
Status:
COMPLETED
Last Update Posted:
2012-03-02
First Post:
2006-05-02
Brief Title:
Human Islet Transplantation in Brittle Type 1 Diabetes Mellitus The GRAGIL 2 Study
Sponsor:
University Hospital Grenoble
Organization:
University Hospital Grenoble
Study Overview
Official Title:
Transplantation dIlots Pancreatiques Allogeniques Adultes Pour le Traitement du Diabete Insulino-dependant Etude GRAGIL 2
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 brittle type 1 insulin-dependent diabetes mellitus and to improve their metabolic control
Detailed Description:
The general objective is to demonstrate the beneficial effect of islet allotransplantation in patients with brittle type 1 diabetes with no endogenous insulin secretion for whom the risk of the spontaneous course of the disease is judged to be worse than the transplantation-related risk The specific objective is to establish reference data for islet transplantation in non-uremic patients with brittle diabetes in a multicentric network setting using the Edmonton protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None