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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-09

Study Completion Date

2020-08-31

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)

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Detailed Description

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Conditions

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NASH - Nonalcoholic Steatohepatitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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F4 patient population

A total of 2 doses are planned to be administered as single or repeated infusions in an ascending manner:

Group Type EXPERIMENTAL

HepaStem

Intervention Type DRUG

Heterologous human adult liver-derived progenitor cells

F3 patient population

A total of 2 doses are planned to be administered as single or repeated infusions in an ascending manner:

Group Type EXPERIMENTAL

HepaStem

Intervention Type DRUG

Heterologous human adult liver-derived progenitor cells

Interventions

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HepaStem

Heterologous human adult liver-derived progenitor cells

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No