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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HepaStem | Biological |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy assessed by clinical parameters | Clinical efficacy parameters evaluated by mortality, liver transplantation and disease scoring. | 28Day, 3 month and 1 year post first infusion day |
| Efficacy assessed by biological parameters |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Brugmann | Brussels | 1020 | Belgium | |||
| Hôpital Erasme |
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| ID | Term |
|---|---|
| D065290 | Acute-On-Chronic Liver Failure |
| ID | Term |
|---|---|
| D017114 | Liver Failure, Acute |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
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Biological efficacy parameters evaluated by bilirubin, creatinine, INR and albumin values
| 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 | Adverse Event of Special Interest defined as : SAE (Serious Adverse Event) with fatal | 3 month and 1 year post first infusion day |
| Brussels |
| 1070 |
| Belgium |
| UZ Antwerpen | Edegem | 2650 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| KU Leuven | Leuven | 3000 | Belgium |
| CHU de Liège | Liège | 4000 | Belgium |
| Cliniques St Luc | Woluwe-Saint-Lambert | 1200 | Belgium |
| Hôpital Beaujon | Clichy | 92110 | France |
| Hôpital de la Croix Rousse | Lyon | 69004 | France |
| Hôpital Paul Brousse | Villejuif | 94804 | France |
| D004066 |
| Digestive System Diseases |