<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/NCT01724697</url>
  </required_header>
  <id_info>
    <org_study_id>20120912-1</org_study_id>
    <nct_id>NCT01724697</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Human Bone Marrow Stem Cells for Treatment of HBV-related Liver Cirrhosis</brief_title>
  <official_title>Safety and Efficacy of Human Autologous Bone Marrow 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;
      stem cells(SCs) possess plasticity and have the potential to differentiate into hepatocyte;&#xD;
      Thus, SCs hold great hope for therapeutic applications. Adult bone marrow is the most common&#xD;
      source of SCs for clinical applications.Previous study showed that bone marrow derived stem&#xD;
      cells (BMSCs) replace hepatocytes in injured liver, and effectively rescue experimental liver&#xD;
      failure and contribute to liver regeneration. In this study, the patients with HBV-related&#xD;
      liver cirrhosis will undergo administration of human autologous BMSCs via hepatic artery to&#xD;
      evaluate the safty and efficacy of human autologous BMSCs treatment for 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, 9 months and 1year after treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AFP</measure>
    <time_frame>1week, 4weeks, 3months, 6months, 9 months and 1year after treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>renal function</measure>
    <time_frame>1week, 4weeks, 3months, 6months, 9 months and 1year after treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>child score</measure>
    <time_frame>1week, 4weeks, 3months, 6months, 9 months 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 treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>conventional treatment &amp; antivrial treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BMSC transplantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>conventional treatment &amp; antiviral treatment &amp; autologous bone marrow stem cell transplantation via hepatic artery</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>BMSC transplantation</intervention_name>
    <description>Patients randomized to the intervention arm will be collected for bone marrow stem cells and then infused with these cells via hepatic artery.</description>
    <arm_group_label>BMSC transplantation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>conventional treatment &amp; antivrial treatment</intervention_name>
    <description>Participants will recieve conventional treatment and antivrial treatment.</description>
    <arm_group_label>conventional treatment</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.theheart,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>
  <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 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>November 7, 2012</last_update_submitted>
  <last_update_submitted_qc>November 7, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 12, 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>end stage liver disease</keyword>
  <keyword>HBV</keyword>
  <keyword>autologous</keyword>
  <keyword>stem cell</keyword>
  <keyword>bone morrow</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/NCT01724697
org study id: 20120912-1
nct id: NCT01724697
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.

      stem cells(SCs) possess plasticity and have the potential to differentiate into hepatocyte;
      Thus, SCs hold great hope for therapeutic applications. Adult bone marrow is the most common
      source of SCs for clinical applications.Previous study showed that bone marrow derived stem
      cells (BMSCs) replace hepatocytes in injured liver, and effectively rescue experimental liver
      failure and contribute to liver regeneration. In this study, the patients with HBV-related
      liver cirrhosis will undergo administration of human autologous BMSCs via hepatic artery to
      evaluate the safty and efficacy of human autologous BMSCs 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, 9 months and 1year after treatment
measure: AFP
time frame: 1week, 4weeks, 3months, 6months, 9 months and 1year after treatment
measure: renal function
time frame: 1week, 4weeks, 3months, 6months, 9 months and 1year after treatment
measure: child score
time frame: 1week, 4weeks, 3months, 6months, 9 months and 1year after treatment
arm group label: conventional treatment
arm group type: Active Comparator
description: conventional treatment & antivrial treatment.
arm group label: BMSC transplantation
arm group type: Experimental
description: conventional treatment & antiviral treatment & autologous bone marrow stem cell transplantation via hepatic artery
intervention type: Other
intervention name: BMSC transplantation
description: Patients randomized to the intervention arm will be collected for bone marrow stem cells and then infused with these cells via hepatic artery.
arm group label: BMSC transplantation
intervention type: Other
intervention name: conventional treatment & antivrial treatment
description: Participants will recieve conventional treatment and antivrial treatment.
arm group label: conventional treatment
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
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