<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/NCT03826433</url>
  </required_header>
  <id_info>
    <org_study_id>SCLnow-XY-04</org_study_id>
    <nct_id>NCT03826433</nct_id>
  </id_info>
  <brief_title>hUC Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosishepatitis b Cirrhosis</brief_title>
  <official_title>Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sclnow Biotechnology Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sclnow Biotechnology Co., Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. Evaluation the safety of using human umbilical mesenchymal stem cells to treat patients&#xD;
           with hepatitis B cirrhosis.&#xD;
&#xD;
        2. Observe the curative effect of patients with hepatitis B cirrhosis who use human&#xD;
           umbilical mesenchymal stem cells to treat.&#xD;
&#xD;
        3. Explore the possible mechanism of human umbilical mesenchymal stem cells to treat&#xD;
           patients with hepatitis B cirrhosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This experimental use umbilical cord mesenchymal stem cells in treatment of decompensated&#xD;
      hepatitis B cirrhosis to evaluate its safety and efficacy,&#xD;
&#xD;
      This experimental is mainly aimed at people aged 18-60 years old, regardless of gender and&#xD;
      with body mass index (BMI) between 19-25kg/m2 (including boundary value). It was decided into&#xD;
      treatment group and control group to evaluate the effectiveness and safety of mesenchymal&#xD;
      stem cells by peripheral intravenous injection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Validity evaluation by detection of the Model for end-stage Liver Disease score of participants</measure>
    <time_frame>12 month</time_frame>
    <description>After finish the mesenchymal stem cell treatment, observe the change in baseline outcome measures.&#xD;
40 or more - 71.3% observed mortality 30-39 - 52.6% observed mortality 20-29 - 19.6% observed mortality 10-19 - 6.0% observed mortality &lt;9 - 1.9% observed mortality</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety evaluation by detecting Blood routine</measure>
    <time_frame>12 month</time_frame>
    <description>To calculate the number of hemocyte and related protein (e.g. erythrocyte, lymphocyte, and hemoglobin) after mesenchymal stem cell treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Validity evaluation by detection of the child-pugh of participants</measure>
    <time_frame>12 month</time_frame>
    <description>After finish the mesenchymal stem cell treatment, observe the change in baseline outcome measures.&#xD;
Points Class One-year survival Two-year survival 5-6 A 100% 85% 7-9 B 80% 60% 10-15 C 45% 35%</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Validity evaluation by detection of the coagulation function of participants</measure>
    <time_frame>12 month</time_frame>
    <description>After finish the mesenchymal stem cell treatment, observe the change of Prothrombin Time and International Normalized Ratio (PT/INR) in baseline outcome measures.&#xD;
The time is around 12-13 seconds, the INR in absence of anticoagulation therapy is 0.8-1.2.</description>
  </other_outcome>
  <other_outcome>
    <measure>Imaging examination</measure>
    <time_frame>12 month</time_frame>
    <description>After finish the mesenchymal stem cell treatment, observe the Computed Tomography (CT).</description>
  </other_outcome>
  <other_outcome>
    <measure>Imaging examination</measure>
    <time_frame>12 month</time_frame>
    <description>Fibro-Touch examination</description>
  </other_outcome>
  <other_outcome>
    <measure>Safety evaluation by detecting adverse events and serious adverse events</measure>
    <time_frame>12 month</time_frame>
    <description>To evaluate the changes of safety indexes before and after mesenchymal stem cell treatment</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Hepatitis B</condition>
  <arm_group>
    <arm_group_label>Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mesenchymal Stem Cells : through peripheral intravenous slowly, every time 6*10^7 (30ml) Other medication of Treatment Group: before the30min of first time to inject stem cells, Intravenous methylprednisone 20mg. All patients require oral nucleoside drugs resistant hepatitis B virus treatment.Use stem cell therapy, by Peripheral iv, 6 * 10 ^ 7 (30 ml)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control Group: Using basic contrast .</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Peripheral iv</intervention_name>
    <description>6*10^7 cells</description>
    <arm_group_label>Treatment Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-60 years old, gender not limited, body mass index (BMI) between 19-25 kg/m2,&#xD;
             including boundary value;&#xD;
&#xD;
          -  The diagnosis of hepatitis B cirrhosis was in line with the 2015 American society of&#xD;
             hepatology (AASLD) guidelines for the treatment of chronic hepatitis B, and the liver&#xD;
             function grade was child-pugh B or child-pugh C, with a score range of 7-12 points,&#xD;
             and Model for End-Stage Liver Disease score≤21 points.&#xD;
&#xD;
          -  Have not received stem cell therapy in the recent 6 months;&#xD;
&#xD;
          -  Subjects will be able to sign the informed consent in accordance with the study&#xD;
             procedures and instructions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Insufficiency of vital organs, such as heart, kidney and lung;&#xD;
&#xD;
          -  End-stage cirrhosis with severe complications, including but not limited to: hepatic&#xD;
             encephalopathy, gastrointestinal bleeding,Severe bleeding tendency, massive ascites,&#xD;
             etc.&#xD;
&#xD;
          -  Concomitant peritonitis, pneumonia, or other types of infection not under control;&#xD;
&#xD;
          -  Have a history of severe allergic reaction or allergy to two or more kinds of food or&#xD;
             medicine;&#xD;
&#xD;
          -  Positive serum HIV antibody and syphilis antibody;&#xD;
&#xD;
          -  Alpha fetoprotein&gt;400ng/mL with primary liver cancer or without imaging evidence;&#xD;
&#xD;
          -  Chronic liver disease and cirrhosis are caused by non-chronic hepatitis B virus&#xD;
             infection, or other factors except chronic hepatitis B virus infection ;&#xD;
&#xD;
          -  Patients with severe mental illness and cognitive impairment;&#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>Xuegong Fan, doctor</last_name>
    <role>Study Director</role>
    <affiliation>Xiangya Hospital of Central South University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lei Guo, doctor</last_name>
    <phone>861064368977</phone>
    <email>georgeguo@sclnow.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xuegong Fan, doctor</last_name>
    <phone>86731-84327392</phone>
    <email>xgfan@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Xiangya Hospital Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410008</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ShaLing Li, doctor</last_name>
      <phone>8613975186154</phone>
    </contact>
    <contact_backup>
      <last_name>Xuegong Fan, doctor</last_name>
      <phone>86731-84327392</phone>
      <email>xgfan@hotmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>April 11, 2023</last_update_submitted>
  <last_update_submitted_qc>April 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hepatitis B Cirrhosis, mesenchymal stem cell</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis B</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03826433
org study id: SCLnow-XY-04
nct id: NCT03826433
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
1. Evaluation the safety of using human umbilical mesenchymal stem cells to treat patients
           with hepatitis B cirrhosis.

        2. Observe the curative effect of patients with hepatitis B cirrhosis who use human
           umbilical mesenchymal stem cells to treat.

        3. Explore the possible mechanism of human umbilical mesenchymal stem cells to treat
           patients with hepatitis B cirrhosis.
This experimental use umbilical cord mesenchymal stem cells in treatment of decompensated
      hepatitis B cirrhosis to evaluate its safety and efficacy,

      This experimental is mainly aimed at people aged 18-60 years old, regardless of gender and
      with body mass index (BMI) between 19-25kg/m2 (including boundary value). It was decided into
      treatment group and control group to evaluate the effectiveness and safety of mesenchymal
      stem cells by peripheral intravenous injection.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Validity evaluation by detection of the Model for end-stage Liver Disease score of participants
time frame: 12 month
description: After finish the mesenchymal stem cell treatment, observe the change in baseline outcome measures.
40 or more - 71.3% observed mortality 30-39 - 52.6% observed mortality 20-29 - 19.6% observed mortality 10-19 - 6.0% observed mortality <9 - 1.9% observed mortality
measure: Safety evaluation by detecting Blood routine
time frame: 12 month
description: To calculate the number of hemocyte and related protein (e.g. erythrocyte, lymphocyte, and hemoglobin) after mesenchymal stem cell treatment
measure: Validity evaluation by detection of the child-pugh of participants
time frame: 12 month
description: After finish the mesenchymal stem cell treatment, observe the change in baseline outcome measures.
Points Class One-year survival Two-year survival 5-6 A 100% 85% 7-9 B 80% 60% 10-15 C 45% 35%
measure: Validity evaluation by detection of the coagulation function of participants
time frame: 12 month
description: After finish the mesenchymal stem cell treatment, observe the change of Prothrombin Time and International Normalized Ratio (PT/INR) in baseline outcome measures.
The time is around 12-13 seconds, the INR in absence of anticoagulation therapy is 0.8-1.2.
measure: Imaging examination
time frame: 12 month
description: After finish the mesenchymal stem cell treatment, observe the Computed Tomography (CT).
measure: Imaging examination
time frame: 12 month
description: Fibro-Touch examination
measure: Safety evaluation by detecting adverse events and serious adverse events
time frame: 12 month
description: To evaluate the changes of safety indexes before and after mesenchymal stem cell treatment
arm group label: Treatment Group
arm group type: Experimental
description: Mesenchymal Stem Cells : through peripheral intravenous slowly, every time 6*10^7 (30ml) Other medication of Treatment Group: before the30min of first time to inject stem cells, Intravenous methylprednisone 20mg. All patients require oral nucleoside drugs resistant hepatitis B virus treatment.Use stem cell therapy, by Peripheral iv, 6 * 10 ^ 7 (30 ml)
arm group label: Control Group
arm group type: No Intervention
description: Control Group: Using basic contrast .
intervention type: Biological
intervention name: Peripheral iv
description: 6*10^7 cells
arm group label: Treatment Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Xuegong Fan, doctor
role: Study Director
affiliation: Xiangya Hospital of Central South University
last name: Lei Guo, doctor
phone: 861064368977
email: georgeguo@sclnow.com
last name: Xuegong Fan, doctor
phone: 86731-84327392
email: xgfan@hotmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Hepatitis
mesh term: Fibrosis
sharing ipd: No