The study will assess the safety of different dose regimens of HepaStem in cirrhotic Patients with ACLF or with acute decompensation at risk of developing ACLF up to Day 28 of the active study period.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
CHU Brugmann
Brussels, Belgium
Hôpital Erasme
Brussels, Belgium
UZ Antwerpen
Edegem, Belgium
UZ Gent
Ghent, Belgium
Safety assessed by occurence of Adverse Events (AE) up to Day 28 of the active study period
Time frame: up to 28Day post first infusion day
Efficacy assessed by clinical parameters
Clinical efficacy parameters evaluated by mortality, liver transplantation and disease scoring.
Time frame: 28Day, 3 month and 1 year post first infusion day
Efficacy assessed by biological parameters
Biological efficacy parameters evaluated by bilirubin, creatinine, INR and albumin values
Time frame: 28Day, 3 month and 1 year post first infusion day
Long term safety Follow up assessed by the occurence of Adverse Event of Special Interest
Adverse Event of Special Interest defined as : SAE (Serious Adverse Event) with fatal
Time frame: 3 month and 1 year post first infusion day
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KU Leuven
Leuven, Belgium
CHU de Liège
Liège, Belgium
Cliniques St Luc
Woluwe-Saint-Lambert, Belgium
Hôpital Beaujon
Clichy, France
Hôpital de la Croix Rousse
Lyon, France
Hôpital Paul Brousse
Villejuif, France