16
Participants
Start Date
August 31, 2016
Primary Completion Date
August 27, 2021
Study Completion Date
August 27, 2021
PolyTregs+IL-2
PolyTregs will be infused into the patient in a single infusion. The first cohort will receive 3 x10\^6 cells. The second cohort will receive 20x10\^6 cells. Following the day 0 infusion of polyclonal Tregs, subjects will receive two 5-day courses of IL-2 (1 x 106 IU daily), the first on days 3-7 and the second on days 38-42. Administration of the second course of IL-2 may be delayed or withheld depending on threshold criteria for peripheral blood Treg frequencies and MMTT-stimulated C-peptide levels determined on day 28.
University of California, San Francisco Medical Center, San Francisco
Yale University, New Haven
Yale University
OTHER
Jeffrey Bluestone
OTHER