<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/NCT03759899</url>
  </required_header>
  <id_info>
    <org_study_id>2018PHB007-01</org_study_id>
    <nct_id>NCT03759899</nct_id>
  </id_info>
  <brief_title>hAECs Are Preliminarily Applied in Allogeneic Hematopoietic Stem Cell Transplantation</brief_title>
  <official_title>Establishment of Clinical Applicable Human Amniotic Epithelial Cell Products and Its Preliminary Application in Allogeneic 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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      hAECs Are Preliminarily Applied in Allogeneic Hematopoietic Stem Cell Transplantation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Establishment of Clinical Applicable Human Amniotic Epithelial Cell Products and Its&#xD;
      Preliminary Application in Allogeneic Hematopoietic Stem Cell Transplantation&#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 2022</completion_date>
  <primary_completion_date type="Anticipated">July 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cell counts of T cells, NK cells, B cells and monocytes</measure>
    <time_frame>Day 7</time_frame>
    <description>proliferation and apoptosis of T cells, NK cells, B cells and monocytes in peripheral blood of patients</description>
  </primary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Leukemia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        leukemia patients with allogeneic HSCT&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  leukemia patients with allogeneic HSCT&#xD;
&#xD;
          -  KFS score &gt;90&#xD;
&#xD;
          -  after transplantation, the patient was implanted (peripheral blood neutrophil absolute&#xD;
             value &gt;500/ul for 3 consecutive days)&#xD;
&#xD;
          -  no uncontrolled infection after transplantation&#xD;
&#xD;
          -  activity II above aGVHD&#xD;
&#xD;
          -  patients agreed to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients refused to participate in the study&#xD;
&#xD;
          -  patients have poor compliance&#xD;
&#xD;
          -  has received hormone therapy&#xD;
&#xD;
          -  patients had serious heart, lung, liver, kidney and other vital organs damage&#xD;
&#xD;
          -  researchers believe that patients who are not suitable for observation study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</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>zhao_xy@bjmu.edu.cn</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>Xiangyu Zhao</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 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>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03759899
org study id: 2018PHB007-01
nct id: NCT03759899
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
hAECs Are Preliminarily Applied in Allogeneic Hematopoietic Stem Cell Transplantation
Establishment of Clinical Applicable Human Amniotic Epithelial Cell Products and Its
      Preliminary Application in Allogeneic Hematopoietic Stem Cell Transplantation
observational model: Case-Only
time perspective: Prospective
measure: Cell counts of T cells, NK cells, B cells and monocytes
time frame: Day 7
description: proliferation and apoptosis of T cells, NK cells, B cells and monocytes in peripheral blood of patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Xiaojun Huang
role: Principal Investigator
affiliation: Peking University People's Hospital
last name: xiangyu Zhao
phone: 010-88325949
email: zhao_xy@bjmu.edu.cn
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
sharing ipd: Undecided