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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
133
Survival
Whether the patients are still alive will be recorded up to Day 90. Time and reason of death will be recorded.
Time frame: Day 90
Liver transplant-free survival
Time frame: Day 90
Transplant-free survival while free of ACLF
Time frame: Day 90
Transplant-free survival with MELD-Na score < 15
Time frame: Day 90
Duration of overall hospitalization and hospitalization in ICU and non-ICU during the index hospitalization
Time frame: up to Day 90
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Medical University Of Vienna
Vienna, Austria
UZ Antwerpen
Antwerp, Belgium
CHU Brugmann
Brussels, Belgium
CHU Erasme
Brussels, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
CHC MontLégia
Liège, Belgium
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski"
Pleven, Bulgaria
UMHAT Medica
Rousse, Bulgaria
...and 37 more locations