Phase II Safety Study of 2 Dose Regimens of HepaStem in Patients With ACLF

Multicenter Phase II Safety and Preliminary Efficacy Study of 2 Dose Regimens of HepaStem in Patients With Acute on Chronic Liver Failure

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02946554

Acronym

HEP101

Enrollment

Registered

2016-10-27

Start date

2016-12-31

Completion date

2020-07-31

Last updated

2020-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute-On-Chronic Liver Failure

Keywords

Acute-On-Chronic Liver Failure, ACLF

Brief summary

The study will assess the safety of different dose regimens of HepaStem in cirrhotic Patients with ACLF or with acute decompensation at risk of developing ACLF up to Day 28 of the active study period.

Interventions

BIOLOGICALHepaStem

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

Main Inclusion Criteria: * Diagnosed cirrhosis * Patient with Acute Decompensation of cirrhosis * Serum total Bilirubin ≥ 6 mg/dL (≥100 umol/L) * The INR measurement has to be : 1.2 ≤ INR \< 2 Main

Exclusion criteria

* Absence of portal vein flow * Known or medical history of thrombotic events * Gastrointestinal hemorrhage requiring blood transfusion * Variceal bading or sclerosis within 4 weeks before infusion * Septic shock or non-controlled bacterial infection * Clinical evidence of aspergilus infection. * Circulatory failure * Respiratory disordered * Coagulation disorders defined as INR ≥ 2, Fibrinogen \< 100 mg/dL or Platelets \< 50.000/mm3 * MELD score \> 30. * Major invasive procedure within 4 weeks before infusion * Previous organ transplantation and/or ongoing immunosuppressive treatments. * Renal failure due to chronic kidney disease. * Clinically significant left-right cardiac shunt.

Design outcomes

Primary

Measure	Time frame
Safety assessed by occurence of Adverse Events (AE) up to Day 28 of the active study period	up to 28Day post first infusion day

Secondary

Measure	Time frame	Description
Efficacy assessed by clinical parameters	28Day, 3 month and 1 year post first infusion day	Clinical efficacy parameters evaluated by mortality, liver transplantation and disease scoring.
Efficacy assessed by biological parameters	28Day, 3 month and 1 year post first infusion day	Biological efficacy parameters evaluated by bilirubin, creatinine, INR and albumin values
Long term safety Follow up assessed by the occurence of Adverse Event of Special Interest	3 month and 1 year post first infusion day	Adverse Event of Special Interest defined as : SAE (Serious Adverse Event) with fatal

Countries

Belgium, France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026