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

Cellaion

Status and phase

Completed

Phase 2

Phase 1

Conditions

NASH - Nonalcoholic Steatohepatitis

Treatments

Drug: HepaStem

Study type

Interventional

Funder types

Industry

Identifiers

NCT03963921

HEP201

Details and patient eligibility

About

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)

Enrollment

23 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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