<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/NCT01728727</url>
  </required_header>
  <id_info>
    <org_study_id>20120912-3</org_study_id>
    <nct_id>NCT01728727</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Human Umbilical Cord Derived Mesenchymal Stem Cells for Treatment of HBV-related Liver Cirrhosis</brief_title>
  <official_title>Safety and Efficacy of Human Umbilical Cord Derived Mesenchymal 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;
      Mesenchymal stem cells (MSCs) possess plasticity and have the potential to differentiate into&#xD;
      hepatocyte; Thus, MSCs hold great hope for therapeutic applications. Human umbilical&#xD;
      cord-derived MSCs (hUC-MSCs) exhibit a more beneficial immunogenic profile and greater&#xD;
      overall immunosuppressive potential than aged bone marrow-derived MSCs. Like MSCs derived&#xD;
      from bone marrow, hUC-MSCs can also be used to treat rat liver fibrosis and improve glucose&#xD;
      homeostasis in rats with liver cirrhosis. In this study, the patients with HBV-related liver&#xD;
      cirrhosis will undergo administration of hUC-MSCs via hepatic artery to evaluate the safety&#xD;
      and efficacy of hUC-MSC 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, 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>UC-MSC transplantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive umbilical cord derived mesenchymal stem cell treatment at day 1 and conventional treatment and antiviral treatment through the one year study visit. Participants will then be followed until one years study visit</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>UC-MSC transplantation</intervention_name>
    <description>After enrolled, Participant will receive umbilical cord MSC transplantation of 1*10E6 cells/kg via hepatic artery. Participant will then be followed until 1 years study visit</description>
    <arm_group_label>UC-MSC 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>end stage liver disease</keyword>
  <keyword>umbilical cord</keyword>
  <keyword>mesenchymal stem cells</keyword>
  <keyword>HBV</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/NCT01728727
org study id: 20120912-3
nct id: NCT01728727
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.

      Mesenchymal stem cells (MSCs) possess plasticity and have the potential to differentiate into
      hepatocyte; Thus, MSCs hold great hope for therapeutic applications. Human umbilical
      cord-derived MSCs (hUC-MSCs) exhibit a more beneficial immunogenic profile and greater
      overall immunosuppressive potential than aged bone marrow-derived MSCs. Like MSCs derived
      from bone marrow, hUC-MSCs can also be used to treat rat liver fibrosis and improve glucose
      homeostasis in rats with liver cirrhosis. In this study, the patients with HBV-related liver
      cirrhosis will undergo administration of hUC-MSCs via hepatic artery to evaluate the safety
      and efficacy of hUC-MSC 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: UC-MSC transplantation
arm group type: Experimental
description: Participants will receive umbilical cord derived mesenchymal stem cell treatment at day 1 and conventional treatment and antiviral treatment through the one year study visit. Participants will then be followed until one years study visit
intervention type: Other
intervention name: UC-MSC transplantation
description: After enrolled, Participant will receive umbilical cord MSC transplantation of 1*10E6 cells/kg via hepatic artery. Participant will then be followed until 1 years study visit
arm group label: UC-MSC 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