<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/NCT03269773</url>
  </required_header>
  <id_info>
    <org_study_id>K0102</org_study_id>
    <nct_id>NCT03269773</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of FURESTEM-AD Inj. in Patients With Moderate to Severe Chronic Atopic Dermatitis(AD)</brief_title>
  <official_title>A Multi-center, Randomized, Double-blind, Parallel, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-AD Inj. for Moderate to Severe Chronic Atopic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kang Stem Biotech Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kang Stem Biotech 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 is multi-center, randomized, double-blind, parallel, placebo-controlled phase III&#xD;
      clinical trial to evaluate the efficacy and safety of FURESTEM-AD Inj. for moderate to severe&#xD;
      chronic atopic dermatitis&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 25, 2018</start_date>
  <completion_date type="Actual">June 20, 2019</completion_date>
  <primary_completion_date type="Actual">March 30, 2019</primary_completion_date>
  <phase>Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>over 50% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-50)</measure>
    <time_frame>12 week</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>over 75% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-75)</measure>
    <time_frame>12 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change and rafe of change in EASI index</measure>
    <time_frame>24weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients who Investigator's Global Assessment (IGA) score 0 or 1</measure>
    <time_frame>24weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients who Investigator's Global Assessment (IGA) score 0 or 1, or reduced more than 2 points</measure>
    <time_frame>24weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>over 50% reduction ratio of SCORing Atopic Dermatitis (SCORAD) INDEX as contrasted with baseline value (SCORAD-50)</measure>
    <time_frame>24weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change and rafe of change in SCORAD index</measure>
    <time_frame>24weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change and rafe of change in Body Surface Area (BSA)</measure>
    <time_frame>24weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in total serum Immunoglobulin E (IgE)</measure>
    <time_frame>24weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cytokine (TNF-a, Interleukin (IL)-4, IL-5, IL-6, IL-8, IL-13, IL-31, TARC (CCL17) and CCL 27 analysis)</measure>
    <time_frame>24weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total number of use and consumed amount of rescue medicine</measure>
    <time_frame>24weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">197</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>FURESTEM-AD Inj.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>hUCB-MSC 5.0x10^7 cells</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>FURESTEM-AD Inj.</intervention_name>
    <description>0.3mL of the following study drug is injected respectively into both upper arms, both thighs, and abdomen (total of 5 regions) as a single dose (total 1.5 mL).&#xD;
Treatment group: FURESTEM-AD® inj. 5.0 X 107 cells/1.5 mL</description>
    <arm_group_label>FURESTEM-AD Inj.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>0.3mL of the following study drug is injected respectively into both upper arms, both thighs, and abdomen (total of 5 regions) as a single dose (total 1.5mL)</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Of either gender, aged &gt;=19&#xD;
&#xD;
          2. Atopic Dermatitis subjects who are coincident with Hanifin and Rajka diagnosis&#xD;
             criteria&#xD;
&#xD;
          3. Chronic Atopic Dermatitis that has been present for at least 3 years&#xD;
&#xD;
          4. EASI&gt;=12 at screening and baseline visit&#xD;
&#xD;
          5. IGA&gt;=3, SCORAD index&gt;=25, BSA &gt;=10% of AD involvement at screegning and baseline visit&#xD;
&#xD;
          6. Subjects with documented record of inadequate response to the stable use of topical&#xD;
             atopic dermatitis treatment within 24 weeks before participating in the study, or whom&#xD;
             are inadvisable due to safety risks&#xD;
&#xD;
          7. Subjects who understand and voluntarily sign an informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with medical history or surgery/procedure history&#xD;
&#xD;
          2. Subjects with diseases at the time of participation in this study (systemic infection,&#xD;
             other serious skin disorders, pigmentation or extensive scarring in atopic dermatitis&#xD;
             symptom region)&#xD;
&#xD;
          3. Subjects who need prohibited medication during clinical period&#xD;
&#xD;
          4. Pregnant, breast-feeding women or women who plan to become pregnant during this study&#xD;
&#xD;
          5. Subjects who currently participate in other clinical trial or participated in other&#xD;
             clinical trial within 4 weeks&#xD;
&#xD;
          6. Any other condition which the investigator judges would make patient unsuitable for&#xD;
             study participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Pusan National University Hospital</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chonnam National University Hospital</name>
      <address>
        <city>Gwangju</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dongguk University Medical Center</name>
      <address>
        <city>Ilsan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gachon University Gil Medical Center</name>
      <address>
        <city>Incheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Catholic Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>137-701</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chung-Ang University Healthcare System</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hanyang University Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ajou University Hospital</name>
      <address>
        <city>Suwon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>October 5, 2016</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>September 10, 2019</last_update_submitted>
  <last_update_submitted_qc>September 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atopic Dermatitis</keyword>
  <keyword>Stem cell</keyword>
  <keyword>Cell therapy</keyword>
  <keyword>skin disease</keyword>
  <keyword>Umbilical cord Blood</keyword>
  <keyword>UCB-MSC</keyword>
  <keyword>hUCB-MSC</keyword>
  <keyword>AD</keyword>
  <keyword>furestem</keyword>
  <keyword>dermatitis</keyword>
  <keyword>eczema</keyword>
  <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>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/NCT03269773
org study id: K0102
nct id: NCT03269773
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is multi-center, randomized, double-blind, parallel, placebo-controlled phase III
      clinical trial to evaluate the efficacy and safety of FURESTEM-AD Inj. for moderate to severe
      chronic atopic dermatitis
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: over 50% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-50)
time frame: 12 week
measure: over 75% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-75)
time frame: 12 week
measure: Change and rafe of change in EASI index
time frame: 24weeks
measure: Proportion of patients who Investigator's Global Assessment (IGA) score 0 or 1
time frame: 24weeks
measure: Proportion of patients who Investigator's Global Assessment (IGA) score 0 or 1, or reduced more than 2 points
time frame: 24weeks
measure: over 50% reduction ratio of SCORing Atopic Dermatitis (SCORAD) INDEX as contrasted with baseline value (SCORAD-50)
time frame: 24weeks
measure: Change and rafe of change in SCORAD index
time frame: 24weeks
measure: Change and rafe of change in Body Surface Area (BSA)
time frame: 24weeks
measure: Change in total serum Immunoglobulin E (IgE)
time frame: 24weeks
measure: Change in Cytokine (TNF-a, Interleukin (IL)-4, IL-5, IL-6, IL-8, IL-13, IL-31, TARC (CCL17) and CCL 27 analysis)
time frame: 24weeks
measure: Total number of use and consumed amount of rescue medicine
time frame: 24weeks
arm group label: FURESTEM-AD Inj.
arm group type: Experimental
description: hUCB-MSC 5.0x10^7 cells
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Biological
intervention name: FURESTEM-AD Inj.
description: 0.3mL of the following study drug is injected respectively into both upper arms, both thighs, and abdomen (total of 5 regions) as a single dose (total 1.5 mL).
Treatment group: FURESTEM-AD® inj. 5.0 X 107 cells/1.5 mL
arm group label: FURESTEM-AD Inj.
intervention type: Other
intervention name: Placebo
description: 0.3mL of the following study drug is injected respectively into both upper arms, both thighs, and abdomen (total of 5 regions) as a single dose (total 1.5mL)
arm group label: Placebo
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
sharing ipd: Undecided