Table 1.

Primary and secondary objectives and outcome measures. CTCAE, Common Terminology Criteria for Adverse Events; SPECT-CT, single photon emission computed tomography; Treg, regulatory T cell.

Objectives	Outcome measures
Primary	Primary
To study the trafficking behaviour and tissue localisation of indium-labelled autologous GMP-Tregs for up to 72 h after infusion.	Gamma camera imaging at 4, 24 and 72 h post Treg reinfusion to assess the kinetics of trafficking plus SPECT-CT at 24 h to quantify tissue uptake of Treg.
Secondary	Secondary
To monitor safety and tolerability of Treg infusions. To measure immunological changes associated with Treg infusions	Adverse events and signs of toxicity were measured by CTCAE criterion/grading score and any changes in clinical, biochemical, immunological tests Immunological changes were assessed by longitudinal immunophenotyping and measurement of serum cytokines and chemokines.