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Umbilical Cord-derived Mesenchymal Stem Cell Infusion for Treating ACLF

NCT06884904 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-03-19

No results posted yet for this study

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

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

Sponsors & Collaborators

  • National Engineering Center of Cell Products

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-15
Primary Completion
2027-04-14
Completion
2028-04-14

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06884904 on ClinicalTrials.gov