Autologous T regulatory cells: Preliminary Phase I data

Preliminary data from an open-label, dose-escalation Phase I trial in 14 Type I diabetics ages 18-45 with a mean duration of disease of 10 months, all of whom retained a baseline level of insulin production, showed that a single infusion of NBS-03 expanded about 500-fold was well tolerated. The Tregs peaked in circulation 3-7 days after infusion and were detectable at >6 months. Additionally, average levels of stimulated C-peptide, an indicator of pancreatic islet beta cell function, remained stable from baseline in some patients for up to 2 years post-treatment. Data were presented at the American Diabetes Association meeting in San Francisco. The trial was conducted at the University of California, San Francisco (UCSF) and Yale University and funded by Juvenile Diabetes Research Foundation (JDRF). This quarter, NeoStem plans to start a Phase II trial of NBS-03 to treat new-onset Type I diabetes. ...