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Controlled randomized pilot study for characterization and identification of CD34+ stem cells in the splancnic distrect after GCSF stimolation in cirrhotic patients - ND

Controlled randomized pilot study for characterization and identification of CD34+ stem cells in the splancnic distrect after GCSF stimolation in cirrhotic patients - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-014721-16-IT
Enrollment
Unknown
Registered
2010-01-08
Start date
2009-11-18
Completion date
Unknown
Last updated
2012-10-29

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

Conditions

Liver cirrhosis

Interventions

Trade Name: GRANULOKINE 30*1FL 30MU 1ML Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: Filgrastim Concentration unit: mg/ml milligram(s)/millilitre Concentration type

Sponsors

ISTITUTO MEDITERRANEO PER I TRAPIANTI E TERAPIE AD ALTA SPECIALIZZAZIONE
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: a) clinical diagnosis (physical signs of chronic liver disease, presence of ascites and/or esophagela varices on upper gastrointestinal endoscopy and/or signs of portal hypertension on ultrasound examination; b) indication to transjugular intrahepatic porto systemic shunt (TIPs) c) informed consent. 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: Hepatocellular carcinoma Portal vein thrombosis. Recent episode og gastrointestinal hemorrhage, Abuse of alcohol. Pulmonary hypertension. History of cancer. HIV infection. Age less than 18 years old.

Design outcomes

Primary

MeasureTime frame
Secondary Objective: The Secondary objectives are: 1) to correlete the CD34+ stem cells productions and the hepatic pressure venous gradient, size of esophageal varices, splenic volume and liver functionality. 2) Phenotypic characterization and functional evaluation of CD34+ stem cells;Primary end point(s): The main aims are: 1) to estabilish if a cirrhotic patients with portal hypertension the CD34+ stem cells is predominantly produced in the splancnic distrect and following a porto-systemic gradient 2)to evaluate if the CD34+ stem cells are able to home the liver.;Main Objective: The main aims are: 1) to estabilish if a cirrhotic patients with portal hypertension the CD34+ stem cells is predominantly produced in the splancnic distrect 2)to evaluate if the CD34+ stem cells are able to home the liver.—

Countries

Italy

Outcome results

None listed

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