Safety and Tolerability of HepaStem in Patients With Cirrhotic and Pre-cirrhotic NASH Patients
- Registration Number
- NCT03963921
- Lead Sponsor
- Cellaion SA
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description F4 patient population HepaStem A total of 2 doses are planned to be administered as single or repeated infusions in an ascending manner: F3 patient population HepaStem A total of 2 doses are planned to be administered as single or repeated infusions in an ascending manner:
- Primary Outcome Measures
Name Time Method Incidence of Adverse Event up to Day 28 Safety and Tolerability
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
Cliniques Universitaires St Luc
🇧🇪Brussels, Belgium
CUB Erasme
🇧🇪Brussel, Belgium
University Hospital Antwerp (UZA)
🇧🇪Edegem, Belgium
UZ Gent
🇧🇪Gent, Belgium
University Multiprofile Hospital for Active Treatment "Tsaritsa Yoana - ISUL"
🇧🇬Sofia, Bulgaria
Multiprofile hospital for active treatment (MHAT) Sofia Military Medical Academy
🇧🇬Sofia, Bulgaria
Trakia Park Hospital
🇧🇬Stara Zagora, Bulgaria
CHU Bordeaux
🇫🇷Bordeaux, France
Paul Brousse Hospital
🇫🇷Villejuif, France
Vall d'Hebron
🇪🇸Barcelona, Spain
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