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

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

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2020-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute-On-Chronic Liver Failure

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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Low dose cohort

Two dose regimens of HepaStem will be given, which differ in the amount of cells per infusion.

The low dose regimen will be given to the first cohort (first 6 patients included in the study).

Group Type OTHER

HepaStem

Intervention Type BIOLOGICAL

High dose cohort

The high dose regimen will be given to the second cohort after evaluation of the safety of the 1st cohort (stepwise approach)

Group Type OTHER

HepaStem

Intervention Type BIOLOGICAL

Interventions

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HepaStem

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No