28-day and 6-month transplant free survival
Time frame · 28-day and 6-month
Cumulative incidence of AKI, sepsis and extrahepatic-extrarenal organ dysfunctions at day 28, day 60 and day 90.
Time frame · Day 28, day 60 and day 90.
Proportion of patients achieving resolution of ACLF (complete and partial) at day 90.
Time frame · Day 90
Improvement in liver severity indices MELD score by 4 points and improvement in AARC grade by 1 from baseline at 28 days, day 60 and day 90.
Time frame · Day 28, Day 60 and Day 90.
Impact on liver injury and regeneration (serum and histology ) at day 28 and day 90.
Time frame · Day 28 and day 90
Change in monocyte energy metabolism (glycolysis and OXPHOS test) and function from baseline at day 3, day 7, day 28 and day 90.
Time frame · Day 3, 7,28 and 90
Change in peripheral blood level of cytokines (pro-inflammatory: TNF-α, IL-6, IL-1β; anti-inflammatory: IL-10, TGF-β), endotoxin and extracellular vesicles (EVs, number of EVs per mL of blood) at baseline, day 3, day14, day 28 and day 90.
Time frame · Day 3,14, 28, 90
Proportion of patients completing treatment without major adverse effects
Time frame · Day 90