<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/NCT01718587</url>
  </required_header>
  <id_info>
    <org_study_id>2012-10-09 TC liver cirrhosis</org_study_id>
    <nct_id>NCT01718587</nct_id>
  </id_info>
  <brief_title>Difference in Efficacy Between Stem Cell Transplantation and Classical Therapy in Liver Cirrhosis Patients</brief_title>
  <official_title>Difference in Efficacy Between Umbilical Cord Mesenchyma Stem Cell Transplantation and Classical Therapy in Liver Cirrhosis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>General Hospital of Chinese Armed Police Forces</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The First Hospital of Hebei Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>General Hospital of Chinese Armed Police Forces</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current treatment methods of liver cirrhosis are limited ,including antiviral&#xD;
      therapy,supportive therapy and liver transplantation. Antiviral therapy and Supportive&#xD;
      therapy especially the regularly intravenous infusions of plasma or albumin are combined in&#xD;
      the clinical classical therapy treatment. In the other hand,umbilical cord mesenchyma stem&#xD;
      cell with self and directed differentiation capacity can effectively rescue experimental&#xD;
      liver failure and contribute to liver regeneration, which suggests the feasibility of stem&#xD;
      cell transplantation therapy. In this study, the safety and efficacy of umbilical cord&#xD;
      mesenchyma stem cell transplantation through interventional procedures and classical therapy&#xD;
      in patients liver cirrhosis will be evaluated and compared.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will includ two research centers, the number of patients in transplantation group&#xD;
      will be 30, the number of patients in classical therapy group will be 30. All the inclusion&#xD;
      and exclusion criteria will be same and the data analysis will be complete by the&#xD;
      epidemiological commissioner.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">July 2014</completion_date>
  <primary_completion_date type="Anticipated">May 2013</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>liver volume calculated by MRI</measure>
    <time_frame>baseline</time_frame>
    <description>Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change from baseline in liver volume calculated by MRI at 6 months</measure>
    <time_frame>6 months after treatment</time_frame>
    <description>Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change from baseline in liver volume calculated by MRI at 12 months</measure>
    <time_frame>12 months after treatment</time_frame>
    <description>Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>blood biochemistry</measure>
    <time_frame>baseline, 1,3,6 and 12 months after treatment or transplantation</time_frame>
    <description>alanine aminotransferase&#xD;
aspartate aminotransferase&#xD;
gamma-glutamyltransferase(GGT)&#xD;
alkaline phosphatase&#xD;
total bilirubin&#xD;
direct bilirubin&#xD;
The total bile acid (TBA)&#xD;
albumin&#xD;
the proportion of white balls</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood test</measure>
    <time_frame>baseline,1,3,6 and 12 months after treatment or transplantation</time_frame>
    <description>platelet count (PLT)&#xD;
mean platelet volume (MPV)&#xD;
platelet distribution width (PDW)&#xD;
platelet hematocrit (PCT)&#xD;
alpha feto protein (AFP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>liver enzyme fiber spectrum</measure>
    <time_frame>baseline,1,3,6 and 12 months after treatment or transplantation</time_frame>
    <description>laminin (LN)&#xD;
Ⅳ collagen detection (CIV)&#xD;
hyaluronic acid (HA)&#xD;
procollagen Ⅲ(PC Ⅲ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>coagulation</measure>
    <time_frame>baselin,1,3,6 and 12 months after treatment or transplantation</time_frame>
    <description>prothrombin time (PT)&#xD;
activated partial thromboplastin time (APTT)&#xD;
fibrinogen (FIB)&#xD;
thrombin time (TT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>portal vein and splenic vein measure</measure>
    <time_frame>baseline,1,3,6 and 12 months after treatment or transplantation</time_frame>
    <description>1)Portal vein diameter (Dpv) 2）Portal vein maximum velocity (Vmaxpv) 3）Portal vein blood flow per minute (Qpv) 4) The splenic vein diameter (Dsv) 5) Splenic vein maximum flow velocity (Vmaxsv) 6) Splenic vein blood flow per minute (Qsv)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>estrogen and progestin in blood</measure>
    <time_frame>baseline,1,3,6 and 12 months after treatment or transplantation</time_frame>
    <description>estrogen and progestin</description>
  </secondary_outcome>
  <other_outcome>
    <measure>liver biopsy</measure>
    <time_frame>baseline,6 and 12 months after transplantation</time_frame>
    <description>The result of liver biopsy judged by the same one expert.</description>
  </other_outcome>
  <other_outcome>
    <measure>gastroscopy</measure>
    <time_frame>baseline,6 and 12 months after treatment or transplantation</time_frame>
    <description>Observe and photograph the related varicose veins.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Liver Cirrhosis</condition>
  <arm_group>
    <arm_group_label>stem cell transplantation therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>umbilical cord mesenchyma stem cell transplantation through interventional procedures do in liver cirrhosis patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>antiviral therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Antiviral therapy: lamivudine, 100 mg per day (oral dose); or adefovir dipivoxil 10 mg per day (oral dose); or grace entecavir 0.5-1mg per day (oral dose); or behalftelbivudine 600 mg per day (oral dose).&#xD;
Supportive therapy are allowed to use on patients not including intravenous infusions of plasma or albumin.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>stem cell transplantation through interventional procedure</intervention_name>
    <description>interventional procedure once</description>
    <arm_group_label>stem cell transplantation therapy</arm_group_label>
    <other_name>UCMSC transplantation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>antiviral therapy (lamivudine, other antiviral drugs)</intervention_name>
    <description>lamivudine, 100 mg per day (oral dose); or adefovir dipivoxil 10 mg per day (oral dose); or grace entecavir 0.5-1mg per day (oral dose); or behalftelbivudine 600 mg per day (oral dose).</description>
    <arm_group_label>antiviral therapy</arm_group_label>
    <other_name>lamivudine or other antiviral drugs.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of liver cirrhosis;&#xD;
&#xD;
          -  Without hepatic encephalopathy;&#xD;
&#xD;
          -  No ascites or have easily dissipated ascites;&#xD;
&#xD;
          -  Value of bilirubin is less than 100;&#xD;
&#xD;
          -  Value of albumin is greater than 16 g / L;&#xD;
&#xD;
          -  Prothrombin time is less than 21 seconds;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe cardiovascular disease, and immunocompromised patients;&#xD;
&#xD;
          -  Patients with localized lesions affecting graft infection;&#xD;
&#xD;
          -  Coagulation disorders;&#xD;
&#xD;
          -  Liver nodules more than 2cm or Liver cancer.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yihua An, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Department of Stem Cell Transplantation, the General Hospital of Chinese People's Armed Police Force</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yihua An, PhD</last_name>
    <phone>0086-10-57976845</phone>
    <email>doctoran2010@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Yihua An</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>October 30, 2012</last_update_submitted>
  <last_update_submitted_qc>October 30, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 31, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>umbilical cord mesenchyma stem cell</keyword>
  <keyword>liver cirrhosis</keyword>
  <keyword>antiviral therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Cirrhosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lamivudine</mesh_term>
    <mesh_term>Antiviral Agents</mesh_term>
  </intervention_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/NCT01718587
org study id: 2012-10-09 TC liver cirrhosis
nct id: NCT01718587
lead sponsor: 
collaborator: 
has dmc: Yes
The current treatment methods of liver cirrhosis are limited ,including antiviral
      therapy,supportive therapy and liver transplantation. Antiviral therapy and Supportive
      therapy especially the regularly intravenous infusions of plasma or albumin are combined in
      the clinical classical therapy treatment. In the other hand,umbilical cord mesenchyma stem
      cell with self and directed differentiation capacity can effectively rescue experimental
      liver failure and contribute to liver regeneration, which suggests the feasibility of stem
      cell transplantation therapy. In this study, the safety and efficacy of umbilical cord
      mesenchyma stem cell transplantation through interventional procedures and classical therapy
      in patients liver cirrhosis will be evaluated and compared.
This study will includ two research centers, the number of patients in transplantation group
      will be 30, the number of patients in classical therapy group will be 30. All the inclusion
      and exclusion criteria will be same and the data analysis will be complete by the
      epidemiological commissioner.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: liver volume calculated by MRI
time frame: baseline
description: Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.
measure: change from baseline in liver volume calculated by MRI at 6 months
time frame: 6 months after treatment
description: Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.
measure: change from baseline in liver volume calculated by MRI at 12 months
time frame: 12 months after treatment
description: Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.
measure: blood biochemistry
time frame: baseline, 1,3,6 and 12 months after treatment or transplantation
description: alanine aminotransferase
aspartate aminotransferase
gamma-glutamyltransferase(GGT)
alkaline phosphatase
total bilirubin
direct bilirubin
The total bile acid (TBA)
albumin
the proportion of white balls
measure: blood test
time frame: baseline,1,3,6 and 12 months after treatment or transplantation
description: platelet count (PLT)
mean platelet volume (MPV)
platelet distribution width (PDW)
platelet hematocrit (PCT)
alpha feto protein (AFP)
measure: liver enzyme fiber spectrum
time frame: baseline,1,3,6 and 12 months after treatment or transplantation
description: laminin (LN)
Ⅳ collagen detection (CIV)
hyaluronic acid (HA)
procollagen Ⅲ(PC Ⅲ)
measure: coagulation
time frame: baselin,1,3,6 and 12 months after treatment or transplantation
description: prothrombin time (PT)
activated partial thromboplastin time (APTT)
fibrinogen (FIB)
thrombin time (TT)
measure: portal vein and splenic vein measure
time frame: baseline,1,3,6 and 12 months after treatment or transplantation
description: 1)Portal vein diameter (Dpv) 2）Portal vein maximum velocity (Vmaxpv) 3）Portal vein blood flow per minute (Qpv) 4) The splenic vein diameter (Dsv) 5) Splenic vein maximum flow velocity (Vmaxsv) 6) Splenic vein blood flow per minute (Qsv)
measure: estrogen and progestin in blood
time frame: baseline,1,3,6 and 12 months after treatment or transplantation
description: estrogen and progestin
measure: liver biopsy
time frame: baseline,6 and 12 months after transplantation
description: The result of liver biopsy judged by the same one expert.
measure: gastroscopy
time frame: baseline,6 and 12 months after treatment or transplantation
description: Observe and photograph the related varicose veins.
arm group label: stem cell transplantation therapy
arm group type: Experimental
description: umbilical cord mesenchyma stem cell transplantation through interventional procedures do in liver cirrhosis patients.
arm group label: antiviral therapy
arm group type: Active Comparator
description: Antiviral therapy: lamivudine, 100 mg per day (oral dose); or adefovir dipivoxil 10 mg per day (oral dose); or grace entecavir 0.5-1mg per day (oral dose); or behalftelbivudine 600 mg per day (oral dose).
Supportive therapy are allowed to use on patients not including intravenous infusions of plasma or albumin.
intervention type: Procedure
intervention name: stem cell transplantation through interventional procedure
description: interventional procedure once
arm group label: stem cell transplantation therapy
other name: UCMSC transplantation
intervention type: Drug
intervention name: antiviral therapy (lamivudine, other antiviral drugs)
description: lamivudine, 100 mg per day (oral dose); or adefovir dipivoxil 10 mg per day (oral dose); or grace entecavir 0.5-1mg per day (oral dose); or behalftelbivudine 600 mg per day (oral dose).
arm group label: antiviral therapy
other name: lamivudine or other antiviral drugs.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Yihua An, PhD
role: Study Director
affiliation: Department of Stem Cell Transplantation, the General Hospital of Chinese People's Armed Police Force
last name: Yihua An, PhD
phone: 0086-10-57976845
email: doctoran2010@hotmail.com
facility: 
country: China
responsible party type: Sponsor
mesh term: Liver Cirrhosis
mesh term: Fibrosis
mesh term: Lamivudine
mesh term: Antiviral Agents