Safety and Tolerability of HepaStem in Patients With Cirrhotic and Pre-cirrhotic NASH Patients

Main Inclusion Criteria:

• Able and willing to provide written informed consent and comply with the requirements of this study protocol
• Age 18 to 70-years old, inclusive
• Proven diagnosis of NASH based on histological evidence from biopsy performed within 6 months for F3 patients and within 2 years for F4 patients prior to Screening If no biopsy is available within these time windows, a biopsy should be performed at Screening NB: For F4 patients for whom the biopsy cannot confirm the diagnosis of NASH, any other causes of underlying liver diseases should be excluded

Main Exclusion Criteria:

• Alcoholic liver disease or alcohol consumption exceeding the daily intake of 140g/w (two doses) for women and of 210g/w (three doses) for men
• Other causes of liver disease including, but not limited to, alcoholic liver disease, active hepatitis B (HbsAg+), hepatitis C (PCR positive), autoimmune disorders, drug-induced hepatotoxicity, Wilson disease, hemochromatosis, and alpha-1-antitryspin deficiency based on medical history and/ or clinical and biological assessment
• Recent recurrent or ongoing thrombotic or bleeding events within 3 months prior the screening
• Patients considered at persistent risk of thrombosis or bleeding at the time of screening
• Patients with high risk of Gastro intestinal bleeding at time of the screening.
• Cerebrovascular, myocardial, or limb arterial thrombotic event within 12 months prior to the screening and/or not considered stabilized by the investigator
• Bariatric surgery within 1 year prior to the screening
• Coagulation disturbances defined as (Drolz et al. 2016, Nadim et al. 2016, Stravitz et al. 2018, Green et al. 2018): fibrinogen at < 80 mg/dL and/or platelets at < 40 x 10³/mm3
• Severe hepatic encephalopathy (defined by West Haven grade > 2)
• Acute Decompensation of cirrhosis with Chronic Liver Failure Consortium Acute Decompensation (CLIF-C AD) score > 60
• Acute on Chronic liver failure (ACLF) grade 1, 2 ,3
• MELD score > 20
• Child Pugh score ≥ C