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

• Conditions: iver cirrhosis

• Registration Number: EUCTR2009-014721-16-IT
• Lead Sponsor: ISTITUTO MEDITERRANEO PER I TRAPIANTI E TERAPIE AD ALTA SPECIALIZZAZIONE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-08
• Last Update Posted: 29 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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.