Islet Transplantation Using Campath-1H and Infliximab Induction
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|ClinicalTrials.gov Identifier: NCT00175266|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : October 2, 2009
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Drug: alemtuzumab Procedure: islet transplant Drug: infliximab||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Islet Transplantation in Type 1 Diabetic Patients Using Campath-1H and Infliximab Induction|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00175266
|University of Alberta - Clinical Islet Transplant Program|
|Edmonton, Alberta, Canada, T6G2C8|
|Principal Investigator:||A.M. James Shapiro, MD, PhD||University of Alberta|