<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/NCT01728688</url>
  </required_header>
  <id_info>
    <org_study_id>20120912-2</org_study_id>
    <nct_id>NCT01728688</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV-related Liver Cirrhosis</brief_title>
  <official_title>Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV-related Liver Cirrhosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Air Force Military Medical University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Second Affiliated Hospital of Chongqing Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eastern Hepatobiliary Surgery Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Air Force Military Medical University, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      HBV related Liver disease is a common medical problem in China. An estimated 7.18% of the&#xD;
      Chinese (about 93 million) is infected with hepatitis B, and most of the HBV- related&#xD;
      hepatitis can developed into liver cirrhosis.&#xD;
&#xD;
      Liver transplantation is the only available life saving treatment for patients with end stage&#xD;
      liver disease. However, lack of donors, surgical complications, rejection, and high cost are&#xD;
      serious problems.&#xD;
&#xD;
      In preclinical studies the investigators have demonstrated that G-CSF mobilized PBSC from&#xD;
      patients with HBV related liver cirrhosis could differentiate into functional hepatocyte and&#xD;
      autologous PBSC transplantation can significantly improve liver synthetic function. But&#xD;
      further studied was needed to confirm the safety and efficacy of PBSC transplantation. In&#xD;
      this study, a prospective, randomized, parallel clinical study was designed. The patients&#xD;
      with HBV-related liver cirrhosis will undergo administration of human autologous PBSCs via&#xD;
      hepatic artery to evaluate the safety and efficacy of human autologous PBSCs treatment for&#xD;
      these patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">September 2015</completion_date>
  <primary_completion_date type="Anticipated">September 2014</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>one-year survival rate</measure>
    <time_frame>one year after treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>MELD score</measure>
    <time_frame>1week, 4weeks,3months, 6months, 9months and 1year after treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Pugh Score</measure>
    <time_frame>1week, 4weeks,3months, 6months, 9months and 1year after treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>alpha fetoprotein</measure>
    <time_frame>1week, 4weeks,3months, 6months, 9months and 1year after treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>renal function</measure>
    <time_frame>1week, 4weeks,3months, 6months, 9months and 1year after treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Liver Cirrhosis</condition>
  <condition>End Stage Liver Disease</condition>
  <arm_group>
    <arm_group_label>Conventional</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>conventional treatment &amp; antiviral treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional &amp; PBSC transplantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After three days G-CSF mobilization, Patients randomized to the intervention arm will receive autologous PBSCs transplantation at day1, and receive conventional treatment and antiviral treatment through the one year study visit and followed until one years study visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PBSC transplantation</intervention_name>
    <description>PBSCs were mobilized with recombinant human G-CSF at 5-10ug/kg/d for three days. then PBSCs were collected by means of apheresis. The collected PBSCs were infused into participant via hepatic artery</description>
    <arm_group_label>conventional &amp; PBSC transplantation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>conventional treatment</intervention_name>
    <description>Participants will receive conventional treatment and antiviral treatment.</description>
    <arm_group_label>Conventional</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged 18-65 years&#xD;
&#xD;
          2. HBV-related liver cirrhosis&#xD;
&#xD;
          3. Child-Pugh score 9-15&#xD;
&#xD;
          4. Written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hepatocellular carcinoma or other malignancies&#xD;
&#xD;
          2. Severe problems in other vital organs(e.g.the heart,renal or lungs)&#xD;
&#xD;
          3. Pregnant or lactating women&#xD;
&#xD;
          4. Severe bacteria infection&#xD;
&#xD;
          5. Anticipated with difficulty of follow-up observation&#xD;
&#xD;
          6. Other candidates who are judged to be not applicable to this study by doctors -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daiming Fan</last_name>
    <role>Study Chair</role>
    <affiliation>Air Force Military Medical University, China</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ying Han</last_name>
    <phone>86-29-84771539</phone>
    <email>hanying@fmmu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yongquan Shi</last_name>
    <phone>86-29-84771515</phone>
    <email>shiyquan@fmmu.edu.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Xijing Hospital of Digestive Disease</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ying Han</last_name>
      <phone>86-29-84771539</phone>
      <email>hanying@fmmu.edu.cn</email>
    </contact>
    <contact_backup>
      <last_name>Yongquan Shi</last_name>
      <phone>86-29-84771515</phone>
      <email>shiyquan@fmmu.edu.cn</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>November 13, 2012</last_update_submitted>
  <last_update_submitted_qc>November 13, 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>Air Force Military Medical University, China</investigator_affiliation>
    <investigator_full_name>Han Ying</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>liver cirrhosis</keyword>
  <keyword>stem cell</keyword>
  <keyword>peripheral blood</keyword>
  <keyword>autologous</keyword>
  <keyword>HBV</keyword>
  <keyword>end stage liver disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Cirrhosis</mesh_term>
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>End Stage Liver Disease</mesh_term>
    <mesh_term>Fibrosis</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/NCT01728688
org study id: 20120912-2
nct id: NCT01728688
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
HBV related Liver disease is a common medical problem in China. An estimated 7.18% of the
      Chinese (about 93 million) is infected with hepatitis B, and most of the HBV- related
      hepatitis can developed into liver cirrhosis.

      Liver transplantation is the only available life saving treatment for patients with end stage
      liver disease. However, lack of donors, surgical complications, rejection, and high cost are
      serious problems.

      In preclinical studies the investigators have demonstrated that G-CSF mobilized PBSC from
      patients with HBV related liver cirrhosis could differentiate into functional hepatocyte and
      autologous PBSC transplantation can significantly improve liver synthetic function. But
      further studied was needed to confirm the safety and efficacy of PBSC transplantation. In
      this study, a prospective, randomized, parallel clinical study was designed. The patients
      with HBV-related liver cirrhosis will undergo administration of human autologous PBSCs via
      hepatic artery to evaluate the safety and efficacy of human autologous PBSCs treatment for
      these patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: one-year survival rate
time frame: one year after treatment
measure: MELD score
time frame: 1week, 4weeks,3months, 6months, 9months and 1year after treatment
measure: Child Pugh Score
time frame: 1week, 4weeks,3months, 6months, 9months and 1year after treatment
measure: alpha fetoprotein
time frame: 1week, 4weeks,3months, 6months, 9months and 1year after treatment
measure: renal function
time frame: 1week, 4weeks,3months, 6months, 9months and 1year after treatment
arm group label: Conventional
arm group type: Active Comparator
description: conventional treatment & antiviral treatment
arm group label: conventional & PBSC transplantation
arm group type: Experimental
description: After three days G-CSF mobilization, Patients randomized to the intervention arm will receive autologous PBSCs transplantation at day1, and receive conventional treatment and antiviral treatment through the one year study visit and followed until one years study visit.
intervention type: Other
intervention name: PBSC transplantation
description: PBSCs were mobilized with recombinant human G-CSF at 5-10ug/kg/d for three days. then PBSCs were collected by means of apheresis. The collected PBSCs were infused into participant via hepatic artery
arm group label: conventional & PBSC transplantation
intervention type: Other
intervention name: conventional treatment
description: Participants will receive conventional treatment and antiviral treatment.
arm group label: Conventional
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Daiming Fan
role: Study Chair
affiliation: Air Force Military Medical University, China
last name: Ying Han
phone: 86-29-84771539
email: hanying@fmmu.edu.cn
last name: Yongquan Shi
phone: 86-29-84771515
email: shiyquan@fmmu.edu.cn
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Air Force Military Medical University, China
investigator full name: Han Ying
investigator title: professor
mesh term: Liver Cirrhosis
mesh term: Liver Diseases
mesh term: End Stage Liver Disease
mesh term: Fibrosis