Safety and Effectiveness of Low Molecular Weight Sulfated Dextran in Islet Transplantation

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.