Alemtuzumab Induction in Islet Transplantation
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Alemtuzumab Induction With Tacrolimus and MMF Maintenance Immunosuppression in Islet Transplantation|
|Study Start Date:||November 2005|
|Study Completion Date:||April 2012|
This trial is a single-center, prospective, open-label study in 12 Type 1 diabetic participants receiving an islet-alone transplant along with alemtuzumab induction therapy followed by combination tacrolimus and MMF maintenance immunosuppression. Participants will receive 1 to 3 infusions of pancreatic islets of sufficient quantity to attain insulin independence.
The primary objective of this protocol is to assess the safety of a treatment regimen utilizing alemtuzumab induction and a combination of tacrolimus and MMF maintenance immunosuppression in adult Type 1 diabetic participants receiving their first islet transplant.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00175253
|University of Alberta - Clinical Islet Transplant Program|
|Edmonton, Alberta, Canada, T6G2C8|
|Principal Investigator:||A.M. James Shapiro, MD, PhD||University of Alberta|