Table 1.

Study Objectives and Endpoints

	Objectives	Endpoints
Primary	Assess the feasibility of isolating and expanding Tregs and of intravenous infusion of ex vivo–expanded autologous polyclonal Tregs in kidney transplant recipients with subclinical graft inflammation	Incidence of failure-to-treat
	Assess the safety of intravenous infusion of ex vivo–expanded autologous polyclonal Tregs in kidney transplant recipients with subclinical graft inflammation	Incidence of infusion reactions Incidence of patient reported adverse events Incidence of laboratory abnormalities Incidence of infection Incidence of malignancy Incidence of acute rejection Incidence of graft dysfunction Patient and graft survival
Secondary	Assess the fate of infused Tregs in circulation	Circulating Treg numbers Percentage of infused Tregs by deuterium tracking Intragraft Tregs in the kidney biopsy by IHC and deuterium tracking
	Assess the impact of infused Tregs on graft inflammation	Inflammatory cell density in the renal allograft by histopathology and IHC Urine cytokines and inflammatory gene expression levels