Table 1.

Summary of data collection for SEPCELL study [38, 39]

Data collection
Demographic and baseline data	Safety data	Efficacy data	Biological data
• Date of birth/age • Gender • Race • Medical history and prior medication taken within 2 weeks before the inclusion in the study • All patients will undergo a complete physical examination at screening and day 1 pre-dose	• All AEs, including TEAEs • Physical examination • Signs of allergic reactions • Vital signs • 12-lead ECG • Laboratory safety assessments • Anti-HLA/donor antibodies	• Ventilator-free days • Vasopressor treatment-free days • Ventilator and vasopressor treatment-free days • Clinical response • APACHE II score • SOFA score	• Anti-HLA/donor antibodies • T-cell response • RNA expression profile of leukocytes and protein levels of biomarkers

AE adverse event, APACHE Acute Physiology A-and Chronic Health Evaluation, ECG electrocardiogram, RNA ribonucleic acid, SOFA Sepsis-related Organ Failure Assessment, TEAE treatment-emergent adverse event