<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/NCT03252340</url>
  </required_header>
  <id_info>
    <org_study_id>AD-CP-17-1</org_study_id>
    <secondary_id>30902</secondary_id>
    <nct_id>NCT03252340</nct_id>
  </id_info>
  <brief_title>Safety of ADSTEM Injection in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis</brief_title>
  <official_title>Observational Study to Evaluate the Safety of ADSTEM Injection in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>EHL Bio Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>EHL Bio Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</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 study aims to evaluate safety in subjects with over moderately subacute and chronic&#xD;
      atopic dermatitis after an intravenous injection of ADSTEM Inj. Since this is an&#xD;
      observational study of patients participated in Phase 1 clinical trials, no drug is&#xD;
      administered in this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be followed-up for adverse events on each visit. Visits will be on 6, 12,&#xD;
      18, 24, 30, 36, 48, 60months after treatment of ADSTEM Inj.&#xD;
&#xD;
      Time perspective is both retrospective and prospective.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 19, 2017</start_date>
  <completion_date type="Actual">September 27, 2022</completion_date>
  <primary_completion_date type="Actual">August 17, 2022</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Tumor formation</measure>
    <time_frame>60months after treatment of ADSTEM Inj.</time_frame>
    <description>The number of subjects with treatment-related tumor formation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>60months after treatment of ADSTEM Inj.</time_frame>
    <description>The number of subjects with treatment-related adverse events</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">11</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>Drug: ADSTEM Inj.</arm_group_label>
    <description>Participants in Phase I clinical trials treated with ADSTEM Inj.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ADSTEM Inj.</intervention_name>
    <description>ADSTEM Inj. 1.0x10^8 mesenchymal stem cells as an intravenous infusion once in Phase I clinical trial.&#xD;
ADSTEM Inj. 3.0x10^8 mesenchymal stem cells as an intravenous infusion once in Phase I clinical trial.</description>
    <arm_group_label>Drug: ADSTEM Inj.</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who participated in Phase I clinical trials&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who participated in Phase I clinical trials&#xD;
&#xD;
          -  Patients who voluntarily agreed to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who can not follow-up from the end of the phase 1 clinical trial to the end&#xD;
             of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Young-joon Seo, M.D, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chungnam National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chungnam National University Hospital</name>
      <address>
        <city>Daejeon</city>
        <state>Chungcheongnam-do</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>February 14, 2023</last_update_submitted>
  <last_update_submitted_qc>February 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</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/NCT03252340
org study id: AD-CP-17-1
secondary id: 30902
nct id: NCT03252340
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to evaluate safety in subjects with over moderately subacute and chronic
      atopic dermatitis after an intravenous injection of ADSTEM Inj. Since this is an
      observational study of patients participated in Phase 1 clinical trials, no drug is
      administered in this study.
Participants will be followed-up for adverse events on each visit. Visits will be on 6, 12,
      18, 24, 30, 36, 48, 60months after treatment of ADSTEM Inj.

      Time perspective is both retrospective and prospective.
observational model: Case-Only
time perspective: Other
measure: Tumor formation
time frame: 60months after treatment of ADSTEM Inj.
description: The number of subjects with treatment-related tumor formation
measure: Adverse events
time frame: 60months after treatment of ADSTEM Inj.
description: The number of subjects with treatment-related adverse events
arm group label: Drug: ADSTEM Inj.
description: Participants in Phase I clinical trials treated with ADSTEM Inj.
intervention type: Drug
intervention name: ADSTEM Inj.
description: ADSTEM Inj. 1.0x10^8 mesenchymal stem cells as an intravenous infusion once in Phase I clinical trial.
ADSTEM Inj. 3.0x10^8 mesenchymal stem cells as an intravenous infusion once in Phase I clinical trial.
arm group label: Drug: ADSTEM Inj.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: 70 Years
healthy volunteers: No
last name: Young-joon Seo, M.D, Ph.D
role: Principal Investigator
affiliation: Chungnam National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
sharing ipd: No