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

NCT02946554 | Completed Phase 2

• 1 other identifier: HEP101
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 10

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.

Conditions

Acute-On-Chronic Liver Failure

Keywords

Acute-On-Chronic Liver Failure; ACLF

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Efficacy assessed by clinical parameters

  28Day, 3 month and 1 year post first infusion day

• Efficacy assessed by biological parameters

  28Day, 3 month and 1 year post first infusion day

• Long term safety Follow up assessed by the occurence of Adverse Event of Special Interest

  3 month and 1 year post first infusion day

Study Arms (2)

Low dose cohort

OTHER

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).

Biological: HepaStem

High dose cohort

OTHER

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

Biological: HepaStem

Interventions

HepaStem BIOLOGICAL

High dose cohort; Low dose cohort

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cellaion SA: lead

Study Sites (10)

CHU Brugmann

Brussels, 1020, Belgium

Location

Hôpital Erasme

Brussels, 1070, Belgium

Location

UZ Antwerpen

Edegem, 2650, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

KU Leuven

Leuven, 3000, Belgium

Location

CHU de Liège

Liège, 4000, Belgium

Location

Cliniques St Luc

Woluwe-Saint-Lambert, 1200, Belgium

Location

Hôpital Beaujon

Clichy, 92110, France

Location

Hôpital de la Croix Rousse

Lyon, 69004, France

Location

Hôpital Paul Brousse

Villejuif, 94804, France

Location

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: October 27, 2016
• Study Start: December 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2020
• Last Updated: October 14, 2020

Record last verified: 2020-10

Locations

BE (7); FR (3)