<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/NCT03764228</url>
  </required_header>
  <id_info>
    <org_study_id>2018PHD006-01</org_study_id>
    <nct_id>NCT03764228</nct_id>
  </id_info>
  <brief_title>Human Amniotic Epithelial Cells Prevent Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation</brief_title>
  <acronym>hAECs-GVHD</acronym>
  <official_title>Single Arm Clinical Study of Human Amniotic Epithelial Cells in Preventing Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking University People's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Single arm clinical study evaluating the safety and efficacy of hAECs in preventing&#xD;
      aGVHD after HSCT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A dose escalation study evaluating the safety and efficacy of human amniotic epithelial&#xD;
      cells( hAECs) in preventing acute graft-versus-host(aGVHD) disease after hematopoietic stem&#xD;
      cell transplantation(HSCT). The doses were 1×10^6、2×10^6、5×^6 cell/kg, successively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">July 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of adverse events</measure>
    <time_frame>1 year</time_frame>
    <description>Safety of HSCT combined with hAECs infusion;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>GVHD</measure>
    <time_frame>1 year</time_frame>
    <description>Occurrence of Graft-versus-host disease after hAECs infusion</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">27</enrollment>
  <condition>Acute-graft-versus-host Disease</condition>
  <arm_group>
    <arm_group_label>hAECs</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infusion of hAECs at the day before HSCT and 7th days after HSCT. The dose is 1×10^6, 2×10^6, 5×10^6 cell/kg, successively.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>hAECs</intervention_name>
    <description>Human amniotic epithelial cells（hAECs）</description>
    <arm_group_label>hAECs</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Standard risk GVHD patients with hematological malignancies;&#xD;
&#xD;
          -  High risk GVHD patients with hematological malignancies: haplotype hematopoietic stem&#xD;
             cell transplantation patients, donor is female or more than 30 years old;&#xD;
&#xD;
          -  Well informed about this study and signed a consent form before the trial;&#xD;
&#xD;
          -  Left ventricular ejection fraction (LVEF) ≧ 50%, no evidence of pericardial effusion;&#xD;
&#xD;
          -  No evidence of lung infection by X-rays examination;&#xD;
&#xD;
          -  Eastern cooperative oncology group (ECOG) performance status of 0 or 1, Hematopoietic&#xD;
             cell transplantation - specific comorbidity index (HCT-CI) of 0, 1, 2;&#xD;
&#xD;
          -  Normal liver and kidney function;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Reduce pretreatment dose or secondary transplantation;&#xD;
&#xD;
          -  participate other clinical trials within 2 months before this study;&#xD;
&#xD;
          -  Female, 1) pregnant/nursing period, or 2) have a pregnancy plan during the study&#xD;
             period, or 3) have fertility and cannot take effective contraception;&#xD;
&#xD;
          -  History of severe allergic disease or is allergic to one or more drugs;&#xD;
&#xD;
          -  Patients who are considered unsuitable for the study by the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiaojun Huang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University People's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiangyu Zhao</last_name>
    <phone>010-88325949</phone>
    <email>13520122292@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Peking University Institute of Hematology</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100044</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhao Xiangyu</last_name>
      <phone>+861088325949</phone>
      <email>xyz80421@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Peking University People's Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100044</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiang-Yu Zhao, M.D., PhD</last_name>
      <phone>8610-88325949</phone>
      <email>zhao_xy@bjmu.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>September 30, 2020</last_update_submitted>
  <last_update_submitted_qc>September 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University People's Hospital</investigator_affiliation>
    <investigator_full_name>Xiaojun Huang,MD</investigator_full_name>
    <investigator_title>Director of the Hematology Department</investigator_title>
  </responsible_party>
  <keyword>human amniotic epithelial cells(hAECs)</keyword>
  <keyword>Acute-graft-versus-host disease（aGVHD）</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Graft vs Host Disease</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/NCT03764228
org study id: 2018PHD006-01
nct id: NCT03764228
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a Single arm clinical study evaluating the safety and efficacy of hAECs in preventing
      aGVHD after HSCT.
A dose escalation study evaluating the safety and efficacy of human amniotic epithelial
      cells( hAECs) in preventing acute graft-versus-host(aGVHD) disease after hematopoietic stem
      cell transplantation(HSCT). The doses were 1×10^6、2×10^6、5×^6 cell/kg, successively.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Occurrence of adverse events
time frame: 1 year
description: Safety of HSCT combined with hAECs infusion;
measure: GVHD
time frame: 1 year
description: Occurrence of Graft-versus-host disease after hAECs infusion
arm group label: hAECs
arm group type: Experimental
description: Infusion of hAECs at the day before HSCT and 7th days after HSCT. The dose is 1×10^6, 2×10^6, 5×10^6 cell/kg, successively.
intervention type: Biological
intervention name: hAECs
description: Human amniotic epithelial cells（hAECs）
arm group label: hAECs
criteria: 
gender: All
minimum age: 8 Years
maximum age: 70 Years
healthy volunteers: No
last name: Xiaojun Huang
role: Principal Investigator
affiliation: Peking University People's Hospital
last name: Xiangyu Zhao
phone: 010-88325949
email: 13520122292@126.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University People's Hospital
investigator full name: Xiaojun Huang,MD
investigator title: Director of the Hematology Department
mesh term: Graft vs Host Disease