drugset / Trial / NCT04229901
Study to Evaluate the Efficacy and Safety of HepaStem in Patients With Acute on Chronic Liver Failure (ACLF)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HepaStem | Cell therapy | 1e+06 cells/kg | Intravenous |