Alcoholic liver disease Nutritional, Metabolic, Endocrine Alcoholic liver disease
Conditions
Interventions
The participants will be randomly allocated to the two study arms in equal numbers by an independent person using the sealed envelope technique.
Intervention arm: Stem cell embolisation in the hepat
Sponsors
Foundation for Liver and Gut Studies (FLAGS) (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years 2. Biopsy-proven alcoholic liver disease 3. Abnormal liver function with a Model for End-Stage Liver Disease (MELD) (assessment that include bilirubin, coagulation time and creatinine) score 10-26 4. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Recent (10 days) infection or hemorrhage 2. Estimated survival 25g/L 8. Known hypersensitivity to G-CSF 9. Creatinine >150 µmol/L 10. Contraindication to arteriography 11. Clinically overt hepatic encephalopathy 12. Absence of written consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of liver function, as assessed by a decrease in the MELD score of >3 between baseline, Day 28, 60, and 90 follow-up visits. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Improvement in liver function as assessed by the following parameters at Day 28, 60, and 90: 1.1. Bilirubin 1.2. Albumin 1.3. Coagulation times 1.4. Presence or absence of ascites 1.5. Presence or absence of hepatic encephalopathy) This will allow the calculation of the Child-Pugh's score 2. Mortality at 3 and 6 months 3. Evolution of serum markers of liver regeneration (AFP, HGF), inflammation (TNF, IL6) and fibrosis (TGF-beta) 4. Changes in liver histology at Day 28 | — |
Countries
Switzerland
Outcome results
None listed