<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/NCT04497805</url>
  </required_header>
  <id_info>
    <org_study_id>ALLO-ASC-SHEET</org_study_id>
    <nct_id>NCT04497805</nct_id>
  </id_info>
  <brief_title>Clinical Study of ALLO-ASC-SHEET in Subjects With Diabetic Wagner Grade II Foot Ulcers</brief_title>
  <official_title>A Phase 2 Clinical Study to Evaluate The Efficacy and Safety of ALLO-ASC-SHEET in the Subjects With Diabetic Wagner Grade II 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>
    <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 Wagner Grade II Foot Ulcers, compared to placebo&#xD;
      therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 8, 2020</start_date>
  <completion_date type="Anticipated">June 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2024</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </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 during the 12 weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to initial complete wound closure between the 2 groups.</measure>
    <time_frame>During 12 weeks</time_frame>
    <description>Measure the time to initial complete wound closure between the 2 groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in wound size compared to baseline between the 2 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 between the 2 groups by the classification of wound size.</measure>
    <time_frame>During 12 weeks</time_frame>
    <description>Proportions of subjects who achieved complete wound closure by the classification of wound size, 1.5~7 cm2 and 7.1~15 cm2 between the 2 groups at every visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportions of subjects who achieved complete wound closure between the 2 groups by the classification of location of diabetic foot ulcer.</measure>
    <time_frame>During 12 weeks</time_frame>
    <description>Proportions of subjects who achieved complete wound closure by the classification of location of diabetic foot ulcer, plantar and dorsal between the 2 groups at every visit by post-hoc analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Durability of complete wound closure for the additional 24 weeks.</measure>
    <time_frame>During 36 weeks</time_frame>
    <description>Durability of complete wound closure for the additional 24 weeks from the initial complete wound closure.&#xD;
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">64</enrollment>
  <condition>Diabetic Foot Ulcer</condition>
  <arm_group>
    <arm_group_label>ALLO-ASC-SHEET</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ALLO-ASC-SHEET 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>Vehicle Control Hydrogel sheet without allogenic adipose-derived mesenchymal stem cells</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ALLO-ASC-SHEET</intervention_name>
    <description>Hydrogel sheet containing Allogenic Mesenchymal Stem Cells</description>
    <arm_group_label>ALLO-ASC-SHEET</arm_group_label>
    <arm_group_label>Hydrogel SHEET(Vehicle control)</arm_group_label>
    <other_name>Hydrogel sheet containing Allogenic Mesenchymal Stem Cells</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female between 18 and 80 years of age.&#xD;
&#xD;
          2. Diagnosed with Type I or Type II diabetes and has Wagner Grade II diabetic foot ulcers&#xD;
             for longer than 4 weeks at the time of screening.&#xD;
&#xD;
          3. Foot ulcer located in the plantar or dorsal, with ulcer size between1.5 cm2 and 15&#xD;
             cm2.&#xD;
&#xD;
          4. Ulcer, Graded II by Wagner grade, and extended to muscle periosteum, muscle, tendon,&#xD;
             or joint capsule, but not to bone.&#xD;
&#xD;
          5. Ulcer is free of necrotic debris,exhibits no signs of clinical infection.&#xD;
&#xD;
          6. Ulcer area blood circulation meets 1 of the following criteria:&#xD;
&#xD;
             A. Blood vessels around the ulcer detected by Doppler Test to have biphasic or&#xD;
             triphasic flow B. Range of Ankle Brachial Index(ABI) is&gt;0.7 to &lt;1.3 C. Transcutaneous&#xD;
             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 2 weeks screening period.&#xD;
&#xD;
          3. Patient is currently on higher dose antibiotic therapy as defined by increased dose or&#xD;
             change in therapy from the initial treatment regimen at screening to treat index wound&#xD;
             infection or patient is on suppressive antibiotic therapy for diabetic foot wound&#xD;
             infection.&#xD;
&#xD;
          4. The longest dimension of the index wound exceeds 15 cm at the baseline visit.&#xD;
&#xD;
          5. Patient with skin lesion confirmed by biopsy (when Investigator deems suspicious) and&#xD;
             then judged by Investigator to be an etiology other than diabetic foot ulcer&#xD;
             (i.e.,example skin cancer in situ, pyoderma).&#xD;
&#xD;
          6. Current evidence of active charcot, osteomyelitis, cellulitis, or evidence of other&#xD;
             infection including fever or purulentdrainage from wound site.&#xD;
&#xD;
          7. Is Human Immunodeficiency Virus (HIV) positive&#xD;
&#xD;
          8. Havesevere hepatic deficiencies.&#xD;
&#xD;
          9. Have a glycated hemoglobin A1c (HbA1c) level of &gt;10%.&#xD;
&#xD;
         10. Have an allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue.&#xD;
&#xD;
         11. Have severe renal function insufficiency documented with creatinine greater than 3.0&#xD;
             mg/dL.&#xD;
&#xD;
         12. Pregnant or breast-feeding.&#xD;
&#xD;
         13. Is unwilling to use an &quot;effective&quot; method of contraception during the study.&#xD;
&#xD;
         14. Have evidence of current infection including purulent drainage from the wound site.&#xD;
&#xD;
         15. Have a clinically relevant history of alcohol or drugs abuse.&#xD;
&#xD;
         16. Have postprandialblood sugar &gt;350 mg/dL at screening.&#xD;
&#xD;
         17. Is not able to comply with the study requirements.&#xD;
&#xD;
         18. Is considered by the Investigator to have a significant disease which might impact the&#xD;
             study.&#xD;
&#xD;
         19. Is considered not suitable for the study by Investigator.&#xD;
&#xD;
         20. Have a history of malignancy within the last 5 years (except basal cell carcinoma in&#xD;
             situ).&#xD;
&#xD;
         21. Is currently or were enrolled in another clinical study within 60 days of screening.&#xD;
&#xD;
         22. Have undergone wound treatments with growth factors, dermal substitutes, or other&#xD;
             biological therapies within the last 30 days.&#xD;
&#xD;
         23. Is receiving oral or parenteral corticosteroids (In doses greater than 10 mg per day),&#xD;
             any immunosuppressive, or cytotoxic agents with unstable dose prior to 4 weeks from&#xD;
             screening.&#xD;
&#xD;
         24. Cannot maintain off-loading process.&#xD;
&#xD;
         25. Panel reactive antibody (PRA) levels ≥ 20% at screening.&#xD;
&#xD;
         26. Venereal Disease Research Laboratory test (VDRL) or RPR positive&#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>Yun Jung Choi, PM</last_name>
    <role>Study Director</role>
    <affiliation>Anterogen Co., Ltd.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yun Jung Choi, PM</last_name>
    <phone>82 10 9199 0164</phone>
    <email>yunjungchoi@anterogen.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jessi Choi, PM</last_name>
    <phone>82 10 9199 0164</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Armstrong, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>May 15, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</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/NCT04497805
org study id: ALLO-ASC-SHEET
nct id: NCT04497805
lead sponsor: 
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 Wagner Grade II Foot Ulcers, compared to placebo
      therapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Proportions of subjects who achieved complete wound closure.
time frame: During 12 weeks
description: Proportions of subjects who achieved complete wound closure during the 12 weeks.
measure: Time to initial complete wound closure between the 2 groups.
time frame: During 12 weeks
description: Measure the time to initial complete wound closure between the 2 groups.
measure: Changes in wound size compared to baseline between the 2 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 between the 2 groups by the classification of wound size.
time frame: During 12 weeks
description: Proportions of subjects who achieved complete wound closure by the classification of wound size, 1.5~7 cm2 and 7.1~15 cm2 between the 2 groups at every visit.
measure: Proportions of subjects who achieved complete wound closure between the 2 groups by the classification of location of diabetic foot ulcer.
time frame: During 12 weeks
description: Proportions of subjects who achieved complete wound closure by the classification of location of diabetic foot ulcer, plantar and dorsal between the 2 groups at every visit by post-hoc analysis.
measure: Durability of complete wound closure for the additional 24 weeks.
time frame: During 36 weeks
description: Durability of complete wound closure for the additional 24 weeks from the initial complete wound closure.
Wound size is measured by using eKare 3D Wound Measurement system(Mobile Devices).
arm group label: ALLO-ASC-SHEET
arm group type: Experimental
description: ALLO-ASC-SHEET Hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells
arm group label: Hydrogel SHEET(Vehicle control)
arm group type: Placebo Comparator
description: Vehicle Control Hydrogel sheet without allogenic adipose-derived mesenchymal stem cells
intervention type: Biological
intervention name: ALLO-ASC-SHEET
description: Hydrogel sheet containing Allogenic Mesenchymal Stem Cells
arm group label: ALLO-ASC-SHEET
arm group label: Hydrogel SHEET(Vehicle control)
other name: Hydrogel sheet containing Allogenic Mesenchymal Stem Cells
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yun Jung Choi, PM
role: Study Director
affiliation: Anterogen Co., Ltd.
last name: Yun Jung Choi, PM
phone: 82 10 9199 0164
email: yunjungchoi@anterogen.com
last name: Jessi Choi, PM
phone: 82 10 9199 0164
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Diabetic Foot
mesh term: Foot Ulcer
mesh term: Ulcer
sharing ipd: No