<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/NCT03754465</url>
  </required_header>
  <id_info>
    <org_study_id>ALLO-ASC-SHEET-102</org_study_id>
    <nct_id>NCT03754465</nct_id>
  </id_info>
  <brief_title>Clinical Study of ALLO-ASC-SHEET in Subjects With Diabetic Foot Ulcers</brief_title>
  <official_title>A Phase 2 Clinical Study to Evaluate the Efficacy and Safety of ALLO-ASC-SHEET in Subjects With Diabetic Foot Ulcers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Anterogen Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Anterogen Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase 2 double-blind clinical study to evaluate the efficacy and Safety of&#xD;
      ALLO-ASC-SHEET in subjects with Diabetic Foot Ulcers, compared to placebo therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Active Group: ALLO-ASC-SHEET&#xD;
&#xD;
        2. Control Group: Hydrogel SHEET (vehicle control)&#xD;
&#xD;
        3. Study Type: Interventional&#xD;
&#xD;
        4. Study Design: Randomized, Comparator-controlled, Double-blind, multi-center study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 9, 2019</start_date>
  <completion_date type="Anticipated">May 2024</completion_date>
  <primary_completion_date type="Anticipated">November 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Double-Blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Proportions of subjects who achieved complete wound closure</measure>
    <time_frame>During 12 weeks</time_frame>
    <description>Proportions of subjects who achieved complete wound closure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to initial complete wound closure between the two groups</measure>
    <time_frame>During 12 weeks</time_frame>
    <description>Time to initial complete wound closure between the two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in wound size compared to baseline between the two groups</measure>
    <time_frame>During 12 weeks</time_frame>
    <description>Wound size is measured by using eKare 3D Wound Measurement system(Mobile Devices)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportions of subjects who achieved complete wound closure by the classification of location of diabetic foot ulcer, Plantar and the other location between the two groups</measure>
    <time_frame>During 12 weeks(at every visit during treatment period)</time_frame>
    <description>Proportions of subjects who achieved complete wound closure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Durability of complete wound closure</measure>
    <time_frame>Follow up to 24 weeks from the initial complete wound closure.</time_frame>
    <description>Wound size is measured by using eKare 3D Wound Measurement system(Mobile Devices)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">56</enrollment>
  <condition>Diabetic Foot Ulcer</condition>
  <arm_group>
    <arm_group_label>ALLO-ASC-DFU</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental: ALLO-ASC-DFU Hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hydrogel SHEET(Vehicle control)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo Comparator: Vehicle Control Hydrogel sheet without allogenic adipose-derived mesenchymal stem cells</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ALLO-ASC-DFU</intervention_name>
    <description>Application of ALLO-ASC-DFU Sheet to diabetic foot ulcer</description>
    <arm_group_label>ALLO-ASC-DFU</arm_group_label>
    <other_name>Hydrogel sheet containing Allogenic Mesenchymal Stem Cells</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hydrogel SHEET(Vehicle control)</intervention_name>
    <description>Application of Hydrogel SHEET to diabetic foot ulcer</description>
    <arm_group_label>Hydrogel SHEET(Vehicle control)</arm_group_label>
    <other_name>Hydrogel sheet without Allogenic Mesenchymal Stem Cells</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female subjects between 18 and 80 years of age.&#xD;
&#xD;
          2. Diagnosed with Type I or Type II diabetics and has diabetic foot ulcers for longer&#xD;
             than 4 weeks at the screening visit.&#xD;
&#xD;
          3. Foot ulcer located in the instep, border or sole of the foot, with ulcer size between&#xD;
             1 cm2 and 15 cm2.&#xD;
&#xD;
          4. Ulcer graded I by Wagner grade, and extended to skin, subcutaneous tissue, but without&#xD;
             exposure of muscle, tendon, bone or joint capsule.&#xD;
&#xD;
          5. Ulcer is free of necrotic debris, exhibits no signs of clinical infection.&#xD;
&#xD;
          6. Ulcer area blood circulation meets one of the following criteria&#xD;
&#xD;
               -  A. Blood vessels around the ulcer detected by Doppler Test&#xD;
&#xD;
               -  B. range of Ankle Brachial Index(ABI) was &gt; 0.7 to &lt; 1.3&#xD;
&#xD;
               -  C. Transcutaneous oxygen pressure, (TcPO2) &gt; 30 mmHg.&#xD;
&#xD;
          7. Is able to give written informed consent prior to study start and to comply with the&#xD;
             study requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Ulcer is of non-diabetic pathophysiology.&#xD;
&#xD;
          2. The ulcer has increased or decreased in size by ≥ 30% during the week after the&#xD;
             Screening Visit.&#xD;
&#xD;
          3. Is Human Immunodeficiency Virus (HIV) positive?&#xD;
&#xD;
          4. Have severe hepatic deficiencies.&#xD;
&#xD;
          5. Have a glycated hemoglobin A1c (HbA1c) level of &gt; 10%.&#xD;
&#xD;
          6. Have allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue.&#xD;
&#xD;
          7. Require intravenous (IV) antibiotics to treat the target wound infection.&#xD;
&#xD;
          8. Have severe renal failure including subject on renal dialysis.&#xD;
&#xD;
          9. Pregnant or breast-feeding.&#xD;
&#xD;
         10. Is unwilling to use an &quot;effective&quot; method of contraception during the study.&#xD;
&#xD;
         11. Have evidence of current infection including pus drainage from the wound site.&#xD;
&#xD;
         12. Have a clinically relevant history of alcohol or drugs abuse.&#xD;
&#xD;
         13. Have postprandial blood sugar &gt; 350 mg/dl.&#xD;
&#xD;
         14. Is not able to understand the objective of this study or to comply with the study&#xD;
             requirements.&#xD;
&#xD;
         15. Is considered by the investigator to have a significant disease which might have&#xD;
             impacted the study.&#xD;
&#xD;
         16. Is considered not suitable for the study by investigator.&#xD;
&#xD;
         17. Have a history of malignancy within the last five years (except basal cell carcinoam&#xD;
             in situ).&#xD;
&#xD;
         18. Is currently or were enrolled in another clinical study within 60 days of screening.&#xD;
&#xD;
         19. Have undergone wound treatments with growth factors, dermal substitutes, or other&#xD;
             biological therapies within the last 30 days.&#xD;
&#xD;
         20. Is receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic&#xD;
             agents with unstable dose prior to 4 weeks from screening.&#xD;
&#xD;
         21. Cannot maintain off-loading process&#xD;
&#xD;
         22. Panel reactive antibody (PRA) levels ≥ 20%&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David G. Armstrong, MD.Ph D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alexander M. Reyzelman, DPM</last_name>
    <role>Principal Investigator</role>
    <affiliation>Center for Clinical Research</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Young Nathan, DPM</last_name>
    <role>Principal Investigator</role>
    <affiliation>Martinsville Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90089</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 25, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>August 23, 2023</last_update_submitted>
  <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 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>Diabetic Foot</mesh_term>
    <mesh_term>Foot Ulcer</mesh_term>
    <mesh_term>Ulcer</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/NCT03754465
org study id: ALLO-ASC-SHEET-102
nct id: NCT03754465
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a phase 2 double-blind clinical study to evaluate the efficacy and Safety of
      ALLO-ASC-SHEET in subjects with Diabetic Foot Ulcers, compared to placebo therapy.
1. Active Group: ALLO-ASC-SHEET

        2. Control Group: Hydrogel SHEET (vehicle control)

        3. Study Type: Interventional

        4. Study Design: Randomized, Comparator-controlled, Double-blind, multi-center study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Double-Blind
measure: Proportions of subjects who achieved complete wound closure
time frame: During 12 weeks
description: Proportions of subjects who achieved complete wound closure
measure: Time to initial complete wound closure between the two groups
time frame: During 12 weeks
description: Time to initial complete wound closure between the two groups
measure: Changes in wound size compared to baseline between the two groups
time frame: During 12 weeks
description: Wound size is measured by using eKare 3D Wound Measurement system(Mobile Devices)
measure: Proportions of subjects who achieved complete wound closure by the classification of location of diabetic foot ulcer, Plantar and the other location between the two groups
time frame: During 12 weeks(at every visit during treatment period)
description: Proportions of subjects who achieved complete wound closure
measure: Durability of complete wound closure
time frame: Follow up to 24 weeks from the initial complete wound closure.
description: Wound size is measured by using eKare 3D Wound Measurement system(Mobile Devices)
arm group label: ALLO-ASC-DFU
arm group type: Experimental
description: Experimental: ALLO-ASC-DFU Hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells
arm group label: Hydrogel SHEET(Vehicle control)
arm group type: Placebo Comparator
description: Placebo Comparator: Vehicle Control Hydrogel sheet without allogenic adipose-derived mesenchymal stem cells
intervention type: Biological
intervention name: ALLO-ASC-DFU
description: Application of ALLO-ASC-DFU Sheet to diabetic foot ulcer
arm group label: ALLO-ASC-DFU
other name: Hydrogel sheet containing Allogenic Mesenchymal Stem Cells
intervention type: Procedure
intervention name: Hydrogel SHEET(Vehicle control)
description: Application of Hydrogel SHEET to diabetic foot ulcer
arm group label: Hydrogel SHEET(Vehicle control)
other name: Hydrogel sheet without Allogenic Mesenchymal Stem Cells
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: David G. Armstrong, MD.Ph D.
role: Principal Investigator
affiliation: University of Southern California
last name: Alexander M. Reyzelman, DPM
role: Principal Investigator
affiliation: Center for Clinical Research
last name: Young Nathan, DPM
role: Principal Investigator
affiliation: Martinsville Research Institute
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetic Foot
mesh term: Foot Ulcer
mesh term: Ulcer
sharing ipd: No