Clinical trial NCT03963921: Safety and Tolerability of HepaStem in Patients With Cirrhotic and Pre-cirrhotic NASH Patients
Official title: Multicenter, Open-label, Safety and Tolerability Study of Ascending Doses of HepaStem in Patients With Cirrhotic and Pre-cirrhotic Non-alcoholic Steato-hepatitis (NASH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: NASH - Nonalcoholic Steatohepatitis
Keywords: NASH
Lead sponsor: Cellaion SA
Sponsor class: INDUSTRY
First posted: 2019-05-28
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)


Eligibility 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

Primary outcomes:
measure: Incidence of Adverse Event
timeFrame: up to Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires St Luc
city: Brussel
country: Belgium
facility: CUB Erasme
city: Edegem
country: Belgium
facility: University Hospital Antwerp (UZA)
city: Gent
country: Belgium
facility: UZ Gent
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment "Tsaritsa Yoana - ISUL"
city: Sofia
country: Bulgaria
facility: Multiprofile hospital for active treatment (MHAT) Sofia Military Medical Academy
city: Stara Zagora
country: Bulgaria
facility: Trakia Park Hospital
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Villejuif
country: France
facility: Paul Brousse Hospital
city: Barcelona
country: Spain
facility: Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
Study officials:
affiliation: CSMO
name: Etienne SOKAL, MD, PhD
role: STUDY_CHAIR
References: