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

Primary Purpose

NASH - Nonalcoholic Steatohepatitis

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

HepaStem

About this trial

This is an interventional treatment trial for NASH - Nonalcoholic Steatohepatitis focused on measuring NASH

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cliniques Universitaires St Luc
CUB Erasme
University Hospital Antwerp (UZA)
UZ Gent
University Multiprofile Hospital for Active Treatment "Tsaritsa Yoana - ISUL"
Multiprofile hospital for active treatment (MHAT) Sofia Military Medical Academy
Trakia Park Hospital
CHU Bordeaux
Paul Brousse Hospital
Vall d'Hebron
Hospital de la Santa Creu i Sant Pau
Hospital General Universitario Gregorio Marañon
Hospital Universitario Ramón y Cajal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

F4 patient population

F3 patient population

Arm Description

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

Outcomes

Primary Outcome Measures

Incidence of Adverse Event

Safety and Tolerability

Secondary Outcome Measures

Full Information

NCT ID

NCT03963921

First Posted

May 23, 2019

Last Updated

October 13, 2020

Sponsor

Cellaion SA

1. Study Identification

Unique Protocol Identification Number

NCT03963921

Brief Title

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

Acronym

PANASH

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

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

April 9, 2019 (Actual)

Primary Completion Date

May 28, 2020 (Actual)

Study Completion Date

August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cellaion SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

NASH - Nonalcoholic Steatohepatitis

Keywords

NASH

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

F4 patient population

Arm Type

Experimental

Arm Description

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

Arm Title

F3 patient population

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

HepaStem

Intervention Description

Heterologous human adult liver-derived progenitor cells

Primary Outcome Measure Information:

Title

Incidence of Adverse Event

Description

Safety and Tolerability

Time Frame

up to Day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Etienne SOKAL, MD, PhD

Organizational Affiliation

CSMO

Official's Role

Study Chair

Facility Information:

Facility Name

Cliniques Universitaires St Luc

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Facility Name

CUB Erasme

City

Brussel

ZIP/Postal Code

1070

Country

Belgium

Facility Name

University Hospital Antwerp (UZA)

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

UZ Gent

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

University Multiprofile Hospital for Active Treatment "Tsaritsa Yoana - ISUL"

City

Sofia

ZIP/Postal Code

1527

Country

Bulgaria

Facility Name

Multiprofile hospital for active treatment (MHAT) Sofia Military Medical Academy

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Facility Name

Trakia Park Hospital

City

Stara Zagora

ZIP/Postal Code

6004

Country

Bulgaria

Facility Name

CHU Bordeaux

City

Bordeaux

ZIP/Postal Code

33604

Country

France

Facility Name

Paul Brousse Hospital

City

Villejuif

ZIP/Postal Code

94804

Country

France

Facility Name

Vall d'Hebron

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Hospital de la Santa Creu i Sant Pau

City

Barcelona

ZIP/Postal Code

08041

Country

Spain

Facility Name

Hospital General Universitario Gregorio Marañon

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Hospital Universitario Ramón y Cajal

City

Madrid

ZIP/Postal Code

28034

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

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

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