Overview

This trial is active, not recruiting.

Condition hepatocellular carcinoma in hepatitis c virus infected patients
Sponsor Cairo University
Start date January 2010
End date February 2013
Trial size 280 participants
Trial identifier NCT01729221, 1

Summary

Prospective study to calculated the incidence of hepatocellular carcinoma in hepatitis C virus infected patients after stem cell therapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Hepatitis C virus infected patients treated by stem cell therapy
Hepatitis C virus infected patients treated by standared line of care

Primary Outcomes

Measure
Incidence of hepatocellular carcinoma post stem cell therapy in hepatitis C virus infected patients
time frame: within the first year after stem cell therapy

Secondary Outcomes

Measure
Compare the incidence of hepatocellular carcinoma in patients who had received stem cell therapy to those who had received the standared line of care
time frame: within one year of follow up of hepatitis C virus infected patients

Eligibility Criteria

Male or female participants from 20 years up to 65 years old.

Inclusion Criteria: - Male or female patients aged from 20 to 65 years of age. - Evidence of chronic liver insufficiency. - The presence of decreased serum albumin and/or increased bilirubin and/or increased international normalized ratio (INR). - Patient is unlikely to receive a liver transplant. - Ability to give written consent - Women of childbearing potential may be included, but must use a reliable and appropriate contraceptive method Exclusion Criteria: - Patients below the age of 20 or above the age of 65 years - Pregnant or lactating women - Patients with recent recurrent GI bleeding or spontaneous bacterial peritonitis - Patients with evidence of HIV or other life threatening infection - Patients unable to give informed consent - Patients with a history of hypersensitivity to G-CSF - Patients who have been included in any other clinical trial within the previous month - Patient with recurrent attacks of hepatic encephalopathy. - Evedince of portal vein thrombosis by ultrasound.

Additional Information

Principal investigator Zekri Abdelrahman, M.SC, Ph,D
Description Our prospective research is carried out in one of the stem cell therapy centers in Egypt where 140 hepatitis C virus infected patients attending for stem cell therapy are enrolled in our study and the patients will be followed up after stem cell therapy where the incidence of hepatocellular carcinoma after stem cell therapy will be calculated , another group of hepatitis C virus infected patients attending to Kasr El Aini university hospital to receive the standered line of care as indicated will be enrolled in our study and will be followed up , where the incidence of hepatocellular carcinoma will be calculated and compared to the previous group , to determine if there is a significant difference between both groups regarding the incidence of hepatocellular and determine whether stem cell therapy affecets the incidence of hepatocellular carcinoma in hepatitis C virus infected patients.
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by Cairo University.