Application of the Stem Cell Therapy in the End Stage Liver Disease and Assessment Its Consequences in the Quality of Live Style as Well as Development of HCC.

Hepatocellular Carcinoma in Hepatitis C Virus Infected Patients Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01729221
• Other study ID #: 1
• Status: Active, not recruiting
• Phase: N/A
• First received: November 17, 2012
• Last updated: November 18, 2012
• Start date: January 2010
• Est. completion date: December 2013

Study information

• Verified date: November 2012
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 280
• Est. completion date: December 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• End Stage Liver Disease
• Hepatitis C
• Hepatocellular Carcinoma in Hepatitis C Virus Infected Patients

Locations

Country	Name	City	State
Egypt	Cairo University & National Cancer Institute	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compare liver function in both groups		after one year of follow up	No
Other	asses liver functions in both groups		after one year of follow up	No
Primary	Incidence of hepatocellular carcinoma post stem cell therapy in hepatitis C virus infected patients		within the first year after stem cell therapy	No
Secondary	Compare the incidence of hepatocellular carcinoma in patients who had received stem cell therapy to those who had received the standared line of care		within one year of follow up of hepatitis C virus infected patients	No