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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-001705-21-IT
Enrollment
Unknown
Registered
2007-04-17
Start date
2007-04-05
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic cirrhosis with severe liver dysfunction MedDRA version: 6.1 Level: PT Classification code 10019663

Interventions

Trade Name: MYELOSTIM 34 F 33,6MIU SIR 1ML Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Lenograstim Concentration unit: µg microgram(s) Concentration type: e

Sponsors

AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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.—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026