Umbilical Cord-derived Mesenchymal Stem Cell Infusion for Treating ACLF
Status:
NOT_YET_RECRUITING
Trial end date:
2028-04-14
Target enrollment:
Participant gender:
Summary
This study is a multicenter, randomized, double-blind, placebo-controlled adaptive design Phase IIb/III clinical trial. It employs a seamless adaptive design, divided into Phase IIb and Phase III, focusing on patients with acute-on-chronic liver failure (ACLF). Eligible patients meeting the inclusion criteria and not disqualified were randomized in a 2:2:1:1 ratio during Phase IIb to receive either a high-dose experimental group (4.010\^6/kg of injectable mesenchymal stem cells derived from umbilical cord), a low-dose group (2.010\^6/kg), a high-dose placebo control group (with equivalent volume of solvent calculated at 4.010\^6/kg), or a low-dose placebo control group (with equivalent volume of solvent calculated at 2.010\^6/kg). In Phase III, patients were randomized in a 1:1 ratio to the experimental group (injectable umbilical cord-derived mesenchymal stem cells) or the control group. All groups received standard treatment alongside either the experimental drug (experimental group) or placebo (control group) to evaluate and confirm the efficacy and safety of injectable umbilical cord-derived mesenchymal stem cells in treating acute-on-chronic liver failure.