T1DM Immunotherapy Using CD4+CD127lo/-CD25+ Polyclonal Tregs

PHASE1CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

November 30, 2010

Primary Completion Date

December 31, 2016

Study Completion Date

January 31, 2017

Conditions
Type 1 Diabetes Mellitus
Interventions
BIOLOGICAL

Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells

The researchers will multiply/expand the Tregs in the laboratory using anti-CD3/anti-CD28 coated beads plus IL-2. Then, the Tregs will be infused back into the patient in a single infusion. The first cohort will receive 0.05 x10\^8 cells. The second cohort will receive 0.4 x10\^8 cells. The third cohort will receive 3.2 x10\^8 cells. The fourth cohort will receive 26 x10\^8 cells.

Trial Locations (2)

94143

University of California, San Francisco Medical Center, San Francisco

06519

Yale University, New Haven

Sponsors
All Listed Sponsors
collaborator

Juvenile Diabetes Research Foundation

OTHER

collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

University of California, San Francisco

OTHER