Marrow stem cell therapy to improve liver function in alcoholic liver disease

Completed

Conditions: Alcoholic liver disease
Nutritional, Metabolic, Endocrine

Registration Number: ISRCTN83972743

Lead Sponsor: Foundation for Liver and Gut Studies (FLAGS) (Switzerland)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

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

1. Recent (10 days) infection or hemorrhage
2. Estimated survival <6 months
3. Coexistent HIV, hepatitis C virus (HCV), hepatitis B virus (HBV)
4. Portal vein obstruction
5. Documented hepatocellular carcinoma
6. Severe liver atrophy as defined by volumetry <0.6% body weight
7. Leucocytes >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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1. Improvement in liver function as assessed by the following parameters at Day 28, 60, and 90: <br>1.1. Bilirubin<br>1.2. Albumin<br>1.3. Coagulation times<br>1.4. Presence or absence of ascites<br>1.5. Presence or absence of hepatic encephalopathy) <br>This will allow the calculation of the Child-Pugh's score<br>2. Mortality at 3 and 6 months<br>3. Evolution of serum markers of liver regeneration (AFP, HGF), inflammation (TNF, IL6) and fibrosis (TGF-beta)<br>4. Changes in liver histology at Day 28