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Clinical Trials/ISRCTN83972743
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.

Registry
who.int
Start Date
March 10, 2008
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

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

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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