Phase II Safety Study of 2 Dose Regimens of HepaStem in Patients With ACLF

Multicenter Phase II Safety and Preliminary Efficacy Study of 2 Dose Regimens of HepaStem in Patients With Acute on Chronic Liver Failure

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.

Main Inclusion Criteria:

• Diagnosed cirrhosis
• Patient with Acute Decompensation of cirrhosis
• Serum total Bilirubin ≥ 6 mg/dL (≥100 umol/L)
• The INR measurement has to be : 1.2 ≤ INR < 2

Main Exclusion Criteria:

• Absence of portal vein flow
• Known or medical history of thrombotic events
• Gastrointestinal hemorrhage requiring blood transfusion
• Variceal bading or sclerosis within 4 weeks before infusion
• Septic shock or non-controlled bacterial infection
• Clinical evidence of aspergilus infection.
• Circulatory failure
• Respiratory disordered
• Coagulation disorders defined as INR ≥ 2, Fibrinogen < 100 mg/dL or Platelets < 50.000/mm3
• MELD score > 30.
• Major invasive procedure within 4 weeks before infusion
• Previous organ transplantation and/or ongoing immunosuppressive treatments.
• Renal failure due to chronic kidney disease.
• Clinically significant left-right cardiac shunt.