Phase II Safety Study of 2 Dose Regimens of HepaStem in Patients With ACLF
- Conditions
- Acute-On-Chronic Liver Failure
- Interventions
- Biological: HepaStem
- Registration Number
- NCT02946554
- Lead Sponsor
- Cellaion SA
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description High dose cohort HepaStem The high dose regimen will be given to the second cohort after evaluation of the safety of the 1st cohort (stepwise approach) Low dose cohort HepaStem 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).
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
Trial Locations
- Locations (10)
CHU Brugmann
🇧🇪Bruxelles, Belgium
UZ Antwerpen
🇧🇪Edegem, Belgium
UZ Gent
🇧🇪Gent, Belgium
Cliniques St Luc
🇧🇪Woluwe-Saint Lambert, Belgium
CHU de Liège
🇧🇪Liège, Belgium
Hôpital Erasme
🇧🇪Brussels, Belgium
Hôpital de la Croix Rousse
🇫🇷Lyon, France
Hôpital Beaujon
🇫🇷Clichy, France
Hôpital Paul Brousse
🇫🇷Villejuif, France
KU Leuven
🇧🇪Leuven, Belgium