ISRCTN83972743
Completed
Not Applicable
Autologous human bone marrow stem cells mobilized by granulocyte colony-stimulating factor (G-CSF) to improve liver function in patients with decompensated alcoholic liver disease: a randomized study
Foundation for Liver and Gut Studies (FLAGS) (Switzerland)0 sites60 target enrollmentMarch 10, 2008
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Alcoholic liver disease
- Sponsor
- Foundation for Liver and Gut Studies (FLAGS) (Switzerland)
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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