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

Study Overview
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Brief Summary
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Multicenter, open-label, safety and tolerability study of ascending doses of HepaStem in patients with cirrhotic and pre-cirrhotic non-alcoholic steato-hepatitis (NASH) to determine the safety and tolerability of ascending single and repeated doses of HepaStem administered to patients with cirrhotic and pre-cirrhotic non-alcoholic steato-hepatitis (NASH)

Official Title
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Multicenter, Open-label, Safety and Tolerability Study of Ascending Doses of HepaStem in Patients With Cirrhotic and Pre-cirrhotic Non-alcoholic Steato-hepatitis (NASH)

Conditions
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NASH - Nonalcoholic Steatohepatitis

Intervention / Treatment
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* Drug: HepaStem


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: F4 patient population<br>A total of 2 doses are planned to be administered as single or repeated infusions in an ascending manner: | Drug: HepaStem<br>* Heterologous human adult liver-derived progenitor cells<br>|
| Experimental: F3 patient population<br>A total of 2 doses are planned to be administered as single or repeated infusions in an ascending manner: | Drug: HepaStem<br>* Heterologous human adult liver-derived progenitor cells<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Event | Safety and Tolerability | up to Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NASH