NCT06884904

Umbilical Cord-derived Mesenchymal Stem Cell Infusion for Treating ACLF

Umbilical Mesenchymal Stem Cells in the Treatment of Acute-on-Chronic Liver Failure：A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase IIb/III Seamless Adaptive Design Clinical Study

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: National Engineering Center of Cell Products · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 (4.0×10\^6/kg of injectable mesenchymal stem cells derived from umbilical cord), a low-dose group (2.0×10\^6/kg), a high-dose placebo control group (with equivalent volume of solvent calculated at 4.0×10\^6/kg), or a low-dose placebo control group (with equivalent volume of solvent calculated at 2.0×10\^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.

Conditions

• Acute-On-Chronic Liver Failure

Interventions

Type	Name	Description
DRUG	Low-dose experimental group	2.0\*10\^6/kg
DRUG	High-dose experimental group	4.0\*10\^6/kg
DRUG	Low-dose placebo control group	Equivalent volume of solvent calculated at 2.0×10\^6/kg
DRUG	High-dose placebo control group	Equivalent volume of solvent calculated at 4.0×10\^6/kg

Timeline

• Start date: 2025-04-15
• Primary completion: 2027-04-14
• Completion: 2028-04-14
• First posted: 2025-03-19
• Last updated: 2025-03-19