Phase II Safety Study of 2 Dose Regimens of HepaStem in Patients With ACLF (HEP101)
Primary Purpose
Acute-On-Chronic Liver Failure
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
HepaStem
Sponsored by
About this trial
This is an interventional treatment trial for Acute-On-Chronic Liver Failure focused on measuring Acute-On-Chronic Liver Failure, ACLF
Eligibility 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.
Sites / Locations
- Hôpital Erasme
- CHU Brugmann
- UZ Antwerpen
- UZ Gent
- KU Leuven
- CHU de Liège
- Cliniques St Luc
- Hôpital Beaujon
- Hôpital de la Croix Rousse
- Hôpital Paul Brousse
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Low dose cohort
High dose cohort
Arm Description
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).
The high dose regimen will be given to the second cohort after evaluation of the safety of the 1st cohort (stepwise approach)
Outcomes
Primary Outcome Measures
Safety assessed by occurence of Adverse Events (AE) up to Day 28 of the active study period
Secondary Outcome Measures
Efficacy assessed by clinical parameters
Clinical efficacy parameters evaluated by mortality, liver transplantation and disease scoring.
Efficacy assessed by biological parameters
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
Adverse Event of Special Interest defined as : SAE (Serious Adverse Event) with fatal
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02946554
Brief Title
Phase II Safety Study of 2 Dose Regimens of HepaStem in Patients With ACLF
Acronym
HEP101
Official Title
Multicenter Phase II Safety and Preliminary Efficacy Study of 2 Dose Regimens of HepaStem in Patients With Acute on Chronic Liver Failure
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
July 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cellaion SA
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute-On-Chronic Liver Failure
Keywords
Acute-On-Chronic Liver Failure, ACLF
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low dose cohort
Arm Type
Other
Arm Description
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).
Arm Title
High dose cohort
Arm Type
Other
Arm Description
The high dose regimen will be given to the second cohort after evaluation of the safety of the 1st cohort (stepwise approach)
Intervention Type
Biological
Intervention Name(s)
HepaStem
Primary Outcome Measure Information:
Title
Safety assessed by occurence of Adverse Events (AE) up to Day 28 of the active study period
Time Frame
up to 28Day post first infusion day
Secondary Outcome Measure Information:
Title
Efficacy assessed by clinical parameters
Description
Clinical efficacy parameters evaluated by mortality, liver transplantation and disease scoring.
Time Frame
28Day, 3 month and 1 year post first infusion day
Title
Efficacy assessed by biological parameters
Description
Biological efficacy parameters evaluated by bilirubin, creatinine, INR and albumin values
Time Frame
28Day, 3 month and 1 year post first infusion day
Title
Long term safety Follow up assessed by the occurence of Adverse Event of Special Interest
Description
Adverse Event of Special Interest defined as : SAE (Serious Adverse Event) with fatal
Time Frame
3 month and 1 year post first infusion day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Hôpital Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
CHU Brugmann
City
Bruxelles
ZIP/Postal Code
1020
Country
Belgium
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
KU Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU de Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Cliniques St Luc
City
Woluwe-Saint Lambert
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Hôpital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
Hôpital de la Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
Hôpital Paul Brousse
City
Villejuif
ZIP/Postal Code
94804
Country
France
12. IPD Sharing Statement
Learn more about this trial
Phase II Safety Study of 2 Dose Regimens of HepaStem in Patients With ACLF
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