<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01729221</url>
  </required_header>
  <id_info>
    <org_study_id>1</org_study_id>
    <nct_id>NCT01729221</nct_id>
  </id_info>
  <brief_title>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.</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective study to calculated the incidence of hepatocellular carcinoma in hepatitis C&#xD;
      virus infected patients after stem cell therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Our prospective research is carried out in one of the stem cell therapy centers in Egypt&#xD;
      where 140 hepatitis C virus infected patients attending for stem cell therapy are enrolled in&#xD;
      our study and the patients will be followed up after stem cell therapy where the incidence of&#xD;
      hepatocellular carcinoma after stem cell therapy will be calculated , another group of&#xD;
      hepatitis C virus infected patients attending to Kasr El Aini university hospital to receive&#xD;
      the standered line of care as indicated will be enrolled in our study and will be followed up&#xD;
      , where the incidence of hepatocellular carcinoma will be calculated and compared to the&#xD;
      previous group , to determine if there is a significant difference between both groups&#xD;
      regarding the incidence of hepatocellular and determine whether stem cell therapy affecets&#xD;
      the incidence of hepatocellular carcinoma in hepatitis C virus infected patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>January 2010</start_date>
  <completion_date type="Anticipated">December 2013</completion_date>
  <primary_completion_date type="Anticipated">February 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of hepatocellular carcinoma post stem cell therapy in hepatitis C virus infected patients</measure>
    <time_frame>within the first year after stem cell therapy</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <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</measure>
    <time_frame>within one year of follow up of hepatitis C virus infected patients</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Compare liver function in both groups</measure>
    <time_frame>after one year of follow up</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>asses liver functions in both groups</measure>
    <time_frame>after one year of follow up</time_frame>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">280</enrollment>
  <condition>Hepatocellular Carcinoma in Hepatitis C Virus Infected Patients</condition>
  <arm_group>
    <arm_group_label>HCV infected patients treated by stem cell therap</arm_group_label>
    <description>Hepatitis C virus infected patients treated by stem cell therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HCV infected patients treated by standared line of care</arm_group_label>
    <description>Hepatitis C virus infected patients treated by standared line of care</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Hepatitis C virus infected patients indicated for stem cell therapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female patients aged from 20 to 65 years of age.&#xD;
&#xD;
          -  Evidence of chronic liver insufficiency.&#xD;
&#xD;
          -  The presence of decreased serum albumin and/or increased bilirubin and/or increased&#xD;
             international normalized ratio (INR).&#xD;
&#xD;
          -  Patient is unlikely to receive a liver transplant.&#xD;
&#xD;
          -  Ability to give written consent&#xD;
&#xD;
          -  Women of childbearing potential may be included, but must use a reliable and&#xD;
             appropriate contraceptive method&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients below the age of 20 or above the age of 65 years&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Patients with recent recurrent GI bleeding or spontaneous bacterial peritonitis&#xD;
&#xD;
          -  Patients with evidence of HIV or other life threatening infection&#xD;
&#xD;
          -  Patients unable to give informed consent&#xD;
&#xD;
          -  Patients with a history of hypersensitivity to G-CSF&#xD;
&#xD;
          -  Patients who have been included in any other clinical trial within the previous month&#xD;
&#xD;
          -  Patient with recurrent attacks of hepatic encephalopathy.&#xD;
&#xD;
          -  Evedince of portal vein thrombosis by ultrasound.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zekri Abdelrahman, M.SC, Ph,D</last_name>
    <role>Study Chair</role>
    <affiliation>National Cancer Institute , Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hosny Salama, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zekri Abdelrahman, M.SC, Ph,D</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Institute, Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cairo University &amp; National Cancer Institute</name>
      <address>
        <city>Cairo</city>
        <zip>002</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 17, 2012</study_first_submitted>
  <study_first_submitted_qc>November 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>November 18, 2012</last_update_submitted>
  <last_update_submitted_qc>November 18, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 20, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Zekri AR</investigator_full_name>
    <investigator_title>Proffesor</investigator_title>
  </responsible_party>
  <keyword>Hepatocellular carcinoma</keyword>
  <keyword>Hepatitis C virus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01729221
org study id: 1
nct id: NCT01729221
lead sponsor: 
has dmc: Yes
Prospective study to calculated the incidence of hepatocellular carcinoma in hepatitis C
      virus infected patients after stem cell therapy.
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.
observational model: Cohort
time perspective: Prospective
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
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
measure: Compare liver function in both groups
time frame: after one year of follow up
measure: asses liver functions in both groups
time frame: after one year of follow up
arm group label: HCV infected patients treated by stem cell therap
description: Hepatitis C virus infected patients treated by stem cell therapy
arm group label: HCV infected patients treated by standared line of care
description: Hepatitis C virus infected patients treated by standared line of care
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Zekri Abdelrahman, M.SC, Ph,D
role: Study Chair
affiliation: National Cancer Institute , Cairo University
last name: Hosny Salama, M.D.
role: Study Director
affiliation: Cairo University
last name: Zekri Abdelrahman, M.SC, Ph,D
role: Principal Investigator
affiliation: National Cancer Institute, Cairo University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Zekri AR
investigator title: Proffesor
mesh term: Hepatitis C
mesh term: Carcinoma, Hepatocellular
mesh term: Hepatitis