Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00446264
Status:
COMPLETED
Last Update Posted:
2012-04-27
First Post:
2007-03-09
Brief Title:
Islet Allotransplantation With Steroid Free Immunosuppression
Sponsor:
University Hospital Lille
Organization:
University Hospital Lille
Study Overview
Official Title:
Sequential Islet Transplantation With Steroid Free Immunosuppression for Type 1 Diabetes
Status:
COMPLETED
Status Verified Date:
2009-02
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:
The restoration of endogenous insulin secretion carries significant hopes for shifting the paradigm of life long exogenous insulin therapy in selected groups of patients with type 1 diabetesT1D After decades of frustrating clinical attempts the Edmonton group set up in 2000 new standards for islet transplantation in patients with brittle T1D by achieving insulin independence in 80 percent of patients These seminal results have however proved much more difficult to duplicate than initially expected
This single center phase 2 clinical trial duplicating the Edmonton protocol is designed for confirming the consistent short term efficacy and safety of sequential islet allotransplantation with steroid free immunosuppression in patients with severe T1D
This single center phase 2 clinical trial duplicating the Edmonton protocol is designed for confirming the consistent short term efficacy and safety of sequential islet allotransplantation with steroid free immunosuppression in patients with severe T1D
Detailed Description:
The short term effectiveness of islet transplantation for alleviating hypoglycemia and controlling glucose homeostasis while limiting or even avoiding the nedd for exogenous insulin has been established despite protocol modifications in donor selection islet preparation or recipient treatment insulin independence with adequate metabolic control was however rarely prolonged beyond two years The most frequently proposed explanations include chronic allogenic rejection recurrence of autoimmunity and beta cell toxicity from administered immunosuppressive drugs
Fourteen patients were enrolled in this single center phase 2 trial initiated in 2003 Eligible patients were males or females between 18 and 65 years of age with type 1 diabeted documented for more than 5 years arginine stimulated C-peptide lower than 02ngml and hypoglycemia awareness or documented metabolic lability Exclusion criteria included body mass index greater than 28Kgm2 unstable arteriopathy or heart disease active infection previous transplantation insulin daily requirements above 12 UIkg creatinin clearance below 60 mlmnm2 or urinary albumin excretion above 300 mgday malignancy smoking desire for pregnancy psychiatric disorders and lack of compliance The study primary efficacy endpoint was graft survival defined as insulin independence and HbA1c65 Secondary outcomes were graft function and metabolic control
Fourteen patients were enrolled in this single center phase 2 trial initiated in 2003 Eligible patients were males or females between 18 and 65 years of age with type 1 diabeted documented for more than 5 years arginine stimulated C-peptide lower than 02ngml and hypoglycemia awareness or documented metabolic lability Exclusion criteria included body mass index greater than 28Kgm2 unstable arteriopathy or heart disease active infection previous transplantation insulin daily requirements above 12 UIkg creatinin clearance below 60 mlmnm2 or urinary albumin excretion above 300 mgday malignancy smoking desire for pregnancy psychiatric disorders and lack of compliance The study primary efficacy endpoint was graft survival defined as insulin independence and HbA1c65 Secondary outcomes were graft function and metabolic control
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AFSSAPS 030209 | OTHER | AFSSAPS | None |
| PHRC | OTHER | None | None |