NASH - Nonalcoholic Steatohepatitis
Conditions
Keywords
NASH
Brief summary
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)
Interventions
DRUGHepaStem
Heterologous human adult liver-derived progenitor cells
Sponsors
Cellaion SA
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Event | up to Day 28 | Safety and Tolerability |
Countries
Belgium, Bulgaria, France, Spain
Outcome results
None listed