Study to Evaluate the Efficacy and Safety of HepaStem in Patients With Acute on Chronic Liver Failure (ACLF)
Study to Evaluate the Efficacy and Safety of HepaStem in Patients With Acute on Chronic Liver Failure (ACLF)
This is an interventional, double blind, randomized (2:1), and placebo-controlled study of 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.
Main Inclusion Criteria:

 -  Initial diagnostic of ACLF, at the investigational site, maximum 3 days before
 signature of the ICF.

 -  Patient with Acute on Chronic Liver Failure Grade 1 or 2 according to the CLIF
 definition*.

 -  Bilirubin value ≥5 mg/dL.

 Main Exclusion Criteria:

 -  ACLF grade 3.

 -  Active uncontrolled bleeding or patient with high risk of short term bleeding up to
 investigator's judgment.

 -  Model for End-Stage Liver Disease (MELD) score >35.

 -  Cerebrovascular, myocardial, limb arterial thrombotic event, or history for both
 thrombotic and hemorrhagic cerebrovascular events within 12 months prior to the
 screening and not considered stabilized by the investigator.

 -  Mechanical ventilation due to respiratory failure, except for hepatic encephalopathy.

 -  Inability to maintain mean BP >60 despite use of vasopressors.

 -  Patients receiving immunosuppressive drugs, except glucocorticoids.

 -  Thrombosis of portal vein.

 -  Underlying cirrhosis due to biliary disease or auto immune hepatitis

 -  Coagulation disturbances defined as (Drolz et al. 2016; Nadim et al. 2016):

 1. fibrinogen <80 mg/dL

 2. platelets <50 x 10³/mm3