Table 1.

Primary and secondary study objectives and endpoints.

Objectives	Endpoints
Primary Objective Assess the safety and feasibility of intravenous infusion of ex vivo selected and expanded autologous polyclonal Tregs in patients with T1DM	Primary Endpoints Adverse events Laboratory abnormalities Signs of toxicity Infusion reactions Complications related to infection Potential negative impact on the course of diabetes
Secondary Objectives Effects on Endogenous Insulin Secretion: assess the effect of Tregs on beta cell function as well as on other measures of diabetes severity Surrogate markers of diabetes immune response: measure the effect of Tregs on the pathologic autoimmune response underlying T1DM and on general immune responsiveness	Secondary Endpoints C-peptide response during mixed meal tolerance tests Insulin use Hemoglobin A1c Secondary surrogate immunologic markers related to general immune function and diabetes autoimmune response