Last updated on December 2013

Long-term Function of Beta Cell Allografts in Non-uremic Type 1 Diabetic Patients


Brief description of study

The present proof of concept study addresses the following specific aims: The general objectives of this work are: 1. To increase and maintain the functional beta-cell mass after islet transplantation under a condition of low-dose tacrolimus 2. To co-investigate the potential of alternative sites for encapsulated beta-cells

Detailed Study Description

1. Aim 1: To increase functional beta cell mass by adding rituximab at first implantation 2. Aim 2: To increase functional beta cell mass by adding basilixumab at second implantation 3. Aim 3: To assess the influence of down-tapering the tacrolimus dose during posttransplant years 2-5 on these data, on metabolic control, on the prevalence of hypoglycemia and on safety parameters. 4. Aim 4: To investigate the potential of the peritoneum and omentum as an alternative site for encapsulated beta-cells. 5. Aim 5: To investigate the potential of the brachioradial muscle as an alternative site for encapsulated beta-cells.

Clinical Study Identifier: NCT00798785

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