Phase II study to evaluate hepatic function and clinical aspects in patients with severe hepatic cirrhosis treated with multiple cycle of stem cells mobilisation by G-CSF administration. - ND

• Conditions: Hepatic cirrhosis with severe liver dysfunction; MedDRA version: 6.1Level: PTClassification code 10019663

• Registration Number: EUCTR2007-001705-21-IT
• Lead Sponsor: AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

AGE 18-80 YEARS Informative consenst availability in absence of psychiatric disease Diagnosis of hepatic cirrhosis viral, alcoholic, metabolic, cryptologic Severe hepatic dysfunction Child Puogh score 8, MELD 15
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

List in orthotopic liver transplantation Drugs allergy Asthma HIV positivity Pregnancy Digestive haemorrhage by portal hypertension within 7 days Acute infection Acute CID Active neoplasm Spleen diameter major then 18 cm

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effect of multiple mobilisations by G-CSF on hepatic function and survival.;Secondary Objective: To evaluate if multiple and periodical mobilisations of hematopoietic stem cells can increase the quantity and the disponibility of cells able to rigenerate the liver. To characterise the phenotype and the genic expression of mobilised stem cells to identify cells able to differentiate into hepatocytes.;Primary end point(s): To evaluate the effect of multiple mobilisations by G-CSF on hepatic function and survival.