Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00285233
Status:
COMPLETED
Last Update Posted:
2012-08-02
First Post:
2006-01-30
Brief Title:
Delayed Mycophenolate Mofetil in Single-Donor Islet Allotransplantation in Type 1 Diabetes
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
An Open-label Pilot Study of Delayed Mycophenolate Mofetil Instead of Tacrolimus Combined With Anti-thymocyte Globulin Daclizumab Etanercept and Sirolimus in Single-donor Solitary Islet Allograft Recipients With Type 1 Diabetes
Status:
COMPLETED
Status Verified Date:
2012-07
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 objective of this study is to assess the safety and efficacy of islet allotransplantation for the reestablishment of stable glycemic control in patients with type 1 diabetes using anti-thymocyte globulin induction immunosuppression with sirolimus mycophenolate mofetil and low dose tacrolimus maintenance immunosuppression
Detailed Description:
To assess the safety and efficacy of a new single-donor islet allotransplant protocol focusing on minimization of ischemic damage by the two-layer pancreas preservation technique attenuation of posttransplant nonspecific inflammatory responses by etanercept and anti-thymocyte globulin deletioninactivation of autoreactive T cells by anti-thymocyte globulin and daclizumab induction immunotherapy and potent yet non-diabetogenic maintenance immunosuppression with sirolimus and delayed mycophenolate mofetil instead of tacrolimus for the reestablishment of stable glycemic control in recipients with type 1 diabetes
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