BioCentury
ARTICLE | Clinical News

Pancreatic islet cells: Phase III data

May 9, 2016 7:00 AM UTC

Top-line data from an open-label, U.S. and Canadian Phase III trial in 48 Type I diabetics with persistent impaired awareness of hypoglycemia who had experienced hypoglycemic events despite physician care showed that 1-3 islet cell transplants injected into the portal vein plus a regimen of immunosuppressive medications consisting of antithymocyte globulin, sirolimus, low-dose tacrolimus and Enbrel etanercept led to cessation of severe hypoglycemic events, near-normal glucose control and restored hypoglycemic awareness 1 year after the first transplant in 88% of patients. After 2 years, 71% of patients continued to meet those criteria for transplant success. ...