Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00285194
Status:
COMPLETED
Last Update Posted:
2012-08-02
First Post:
2006-01-30
Brief Title:
hOKT3γ1 Ala-Ala Combined With Sirolimus and Delayed Tacrolimus in Type 1 Diabetic Islet Allograft Recipients
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
hOKT3γ1 Ala-Ala Combined With Sirolimus and Delayed Tacrolimus in Type 1 Diabetic Islet Allograft Recipients
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 collective effects of two-layer pancreas preservation pretransplant islet culture day -2 pretransplant immunosuppression and induction immunosuppression with the FcR-nonbinding anti-CD3 monoclonal antibody hOKT3γ1 Ala-Alato facilitate diabetes reversal after single-donor islet transplantation
Detailed Description:
This is an open-label one-year follow-up study of type 1 diabetic islet allograft recipients who receive FcR non-binding OKT3 antibody hOKT3γ1 Ala-Ala plus sirolimus induction immunotherapy combined with sirolimus and delayed tacrolimus maintenance immunosuppression Six subjects were transplanted
The premise behind the proposal is that hOKT3γ1Ala-Ala corrects the imbalance between autoreactive and regulatory T cells and consequently prevents autoimmune destruction of transplanted islets To prevent allorejection hOKT3γ1Ala-Alawas combined with sirolimus and delayed tacrolimus Additionally the safety and efficacy of the maintenance immunosuppressive regimen of sirolimus combined with tacrolimus was monitored
The premise behind the proposal is that hOKT3γ1Ala-Ala corrects the imbalance between autoreactive and regulatory T cells and consequently prevents autoimmune destruction of transplanted islets To prevent allorejection hOKT3γ1Ala-Alawas combined with sirolimus and delayed tacrolimus Additionally the safety and efficacy of the maintenance immunosuppressive regimen of sirolimus combined with tacrolimus was monitored
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