Safety and Effectiveness of Low Molecular Weight Sulfated Dextran in Islet Transplantation (CIT-01)

General Description

The CIT consortium conducted a total of 9 studies across North America (CIT02 through CIT08) and the Nordic region (CIT01). CIT08 was a long-term follow-up study for interested participants at the North American sites. The target population is individuals with type 1 diabetes, normal kidney function, and intractable hypoglycemia. All studies treated participants with up to 3 separate infusions of islets. CIT01 participants were randomized to study treatment including Low Molecular Weight Sulfated Dextran (LMW-DS) and study treatment without LMW-DS. Subjects in both arms received induction and maintenance immunosuppression consisting of ATG (basiliximab instead of ATG for the 2nd and 3rd transplants, if applicable), etanercept, sirolimus, and tacrolimus. CIT01 subjects randomized to the LMW-DS arm also received LMW-DS before and during islet transplant.

Objectives

The primary objective is to evaluate the safety and efficacy of Low Molecular Weight Dextran Sulfate (LMW-DS) to enhance engraftment and prevent IBMIR in islet transplantation to Type 1 diabetic subjects. The secondary objective is to gather additional safety and efficacy information about the combination of Low Molecular Weight Sulfated Dextran with islet transplantation.

Outcome Measure

The level of stimulated c-peptide at 90-minutes derived from the mixed-meal tolerance test (MMTT) at 75+/-5 days following the first islet infusion.

Outcome

This study has ended.