drugset / Trial / NCT04229901

Study to Evaluate the Efficacy and Safety of HepaStem in Patients With Acute on Chronic Liver Failure (ACLF)

NCT04229901 ↗

Phase 2 Terminated 133 enrolled Cellaion SA
RandomizedParallel-groupDouble-blindTreatment

Summary

This is an interventional, double blind, randomized (2:1), and placebo-controlled study of 2 infusions of a 1 dose regimen of HepaStem in patients recently diagnosed (≤1 week) with ACLF grade 1 or 2 on top of Standard of Care (SoC), and for whom the diagnosis is not resolved on the day of infusion.

Timeline

Start
2020-01-21
Primary completion
2024-05-10
Completion
2024-05-10

Outcome

Outcome not reported

Stopped (Business): “Sponsor decision”

Drugs

EvaluationDrugModalityDoseRoute
Subject HepaStem Cell therapy 1e+06 cells/kg Intravenous

Indications