<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/NCT04464213</url>
  </required_header>
  <id_info>
    <org_study_id>HS201901</org_study_id>
    <nct_id>NCT04464213</nct_id>
  </id_info>
  <brief_title>Human Placental Mesenchymal Stem Cells Treatment on Diabetic Foot Ulcer</brief_title>
  <official_title>Phase I Clinical Trials of Human Placental Mesenchymal Stem Cells Treatment on Diabetic Foot Ulcer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Tongren Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Tongren Hospital</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 is designated to:&#xD;
&#xD;
        1. investigate the tolerance and safety of treatment of Human placental mesenchymal stem&#xD;
           cells gel on Human diabetic foot ulcer.&#xD;
&#xD;
        2. learn the primary effectiveness of Human placental mesenchymal stem cells gel on Human&#xD;
           diabetic food ulcer.&#xD;
&#xD;
        3. study the pharmacokinetics of Human placental mesenchymal stem cells gel on Human&#xD;
           diabetic food ulcer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2023</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of adverse event</measure>
    <time_frame>0 hour - 24 hours</time_frame>
    <description>The rate of adverse event in 24 hours after single dose of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of adverse event</measure>
    <time_frame>0 Day - 7 Days</time_frame>
    <description>The rate of adverse event in 7 days after multi-dose of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of serious adverse event</measure>
    <time_frame>0 hour - 1 hour</time_frame>
    <description>The rate of serious adverse event in 1 hour after single dose of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of cure rate</measure>
    <time_frame>0 day - 34 days</time_frame>
    <description>Rate of cure rate in 20 days and 34 days after multi-dose of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">43</enrollment>
  <condition>Diabetic Foot Ulcer</condition>
  <arm_group>
    <arm_group_label>Single dose experiments</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Multi-dose experiments</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Single dose experiments</intervention_name>
    <description>In single dose experiments, after clean the diabetic foot ulcer, paint the Human placental mesenchymal stem cells gel on the wound, each patient only receive treatment once time.</description>
    <arm_group_label>Single dose experiments</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Multi-dose experiments</intervention_name>
    <description>In multi-dose experiments, after clean the diabetic foot ulcer, paint the Human placental mesenchymal stem cells gel on the wound, each patient receive treatment on six consecutive days.</description>
    <arm_group_label>Multi-dose experiments</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 and Age ≤ 75&#xD;
&#xD;
          -  Type 1 or type 2 diabetes mellitus, glycosylated hemoglobin ≤ 9.0%&#xD;
&#xD;
          -  Diagnosed as condition of diabetic foot ulcer, Wagner grade at 1 or 2 after clinical&#xD;
             treatment&#xD;
&#xD;
          -  Full understand the informed consent form, and signed it voluntarily&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breast-feed women or plan to pregnant or fail to take an efficient&#xD;
             contraception&#xD;
&#xD;
          -  Be allergic to any component of the drug or showed allergic constitution&#xD;
&#xD;
          -  Showed a sign of systemic infection, or with complication of ethmyphitis, or&#xD;
             osteomyelitis indicated by MRI&#xD;
&#xD;
          -  Have malignancy in the ulcer pathology test, or have a history of malignant tumor&#xD;
&#xD;
          -  Unable to clean the wounds due to the formation of tract between the ulcer and other&#xD;
             condition&#xD;
&#xD;
          -  Infected with hepatitis B virus (HBV), hepatitis virus C (HCV), human immunodeficiency&#xD;
             virus (HIV), or treponema pallidum&#xD;
&#xD;
          -  Alanine transaminase (ALT) or aspartate transaminase (AST) exceeds 2.5 times of the&#xD;
             normal value, or Cr&gt;200 μmol/L&#xD;
&#xD;
          -  Have a history of apoplexy, unstable angina pectoris, myocardial infarct&#xD;
&#xD;
          -  Have a psychiatric history, drug abuse or alcohol abuse history&#xD;
&#xD;
          -  Had participated in any other clinical trials in the past 3 months&#xD;
&#xD;
          -  Any other circumstances judged by the researchers disqualify the patient to&#xD;
             participate in the trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiuli Zhao, Doc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Tongren Hospital, CMU</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Siyang Ni, Doc</last_name>
    <phone>+(86)-18911810275</phone>
    <email>grandnsy@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Institute for Drug Clinical Trial, Beijing Tongren Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beiijng</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Siyang Ni, Doc</last_name>
      <phone>+（86）-18911810275</phone>
      <email>grandnsy@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>October 19, 2022</last_update_submitted>
  <last_update_submitted_qc>October 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Human placental mesenchymal stem cells</keyword>
  <keyword>Gel</keyword>
  <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>
  <!-- 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/NCT04464213
org study id: HS201901
nct id: NCT04464213
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is designated to:

        1. investigate the tolerance and safety of treatment of Human placental mesenchymal stem
           cells gel on Human diabetic foot ulcer.

        2. learn the primary effectiveness of Human placental mesenchymal stem cells gel on Human
           diabetic food ulcer.

        3. study the pharmacokinetics of Human placental mesenchymal stem cells gel on Human
           diabetic food ulcer.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of adverse event
time frame: 0 hour - 24 hours
description: The rate of adverse event in 24 hours after single dose of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.
measure: Rate of adverse event
time frame: 0 Day - 7 Days
description: The rate of adverse event in 7 days after multi-dose of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.
measure: Rate of serious adverse event
time frame: 0 hour - 1 hour
description: The rate of serious adverse event in 1 hour after single dose of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.
measure: Rate of cure rate
time frame: 0 day - 34 days
description: Rate of cure rate in 20 days and 34 days after multi-dose of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.
arm group label: Single dose experiments
arm group type: Experimental
arm group label: Multi-dose experiments
arm group type: Experimental
intervention type: Other
intervention name: Single dose experiments
description: In single dose experiments, after clean the diabetic foot ulcer, paint the Human placental mesenchymal stem cells gel on the wound, each patient only receive treatment once time.
arm group label: Single dose experiments
intervention type: Other
intervention name: Multi-dose experiments
description: In multi-dose experiments, after clean the diabetic foot ulcer, paint the Human placental mesenchymal stem cells gel on the wound, each patient receive treatment on six consecutive days.
arm group label: Multi-dose experiments
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Xiuli Zhao, Doc
role: Principal Investigator
affiliation: Beijing Tongren Hospital, CMU
last name: Siyang Ni, Doc
phone: +(86)-18911810275
email: grandnsy@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Diabetic Foot
mesh term: Foot Ulcer
mesh term: Ulcer