Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00175266
Status:
COMPLETED
Last Update Posted:
2009-10-02
First Post:
2005-09-12
Brief Title:
Islet Transplantation Using Campath-1H and Infliximab Induction
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
Official Title:
Islet Transplantation in Type 1 Diabetic Patients Using Campath-1H and Infliximab Induction
Status:
COMPLETED
Status Verified Date:
2009-10
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:
Islet transplantation has been investigated as a treatment for Type 1 diabetes mellitus in selected patients with inadequate glucose control despite insulin therapy However the perennial hope that such an approach would result in long-term freedom from the need for exogenous insulin with stabilization of the secondary complications of diabetes has failed to materialize in practice The goal of the present study is therefore to improve the safety and efficacy of clinical islet-alone transplantation by minimizing dependence on calcineurin-inhibitor therapy - thereby avoiding potential nephrotoxicity and furthermore improving success with single-donor islet infusions by avoiding all diabetogenic immunosuppression Campath-1H combined with Infliximab induction therapy provides a unique opportunity to minimize dosing of maintenance long-term immunosuppression while further promoting islet engraftment
Detailed Description:
This is a single-centre prospective open-label study in Type 1 diabetic participants receiving an islet cell transplant all participants will receive Campath-1H Infliximab induction therapy followed by sirolimus and ultra-low dose tacrolimus maintenance therapy
The primary objective of this protocol is to assess the safety of this treatment regimen in adult Type 1 diabetic participants receiving their first islet transplant
The primary objective of this protocol is to assess the safety of this treatment regimen in adult Type 1 diabetic participants receiving their first islet transplant
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