<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/NCT03237442</url>
  </required_header>
  <id_info>
    <org_study_id>SSCST-MSC-OCB-01</org_study_id>
    <nct_id>NCT03237442</nct_id>
  </id_info>
  <brief_title>Umbilical Cord Mesenchymal Stem Cells Injection for Ocular Corneal Burn</brief_title>
  <official_title>Placebo-Controlled,Randomized,Double-blind Trial of Umbilical Cord Mesenchymal Stem Cells Injection for Ocular Corneal Burn</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangzhou Saliai Stem Cell Science and Technology Co. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangzhou Saliai Stem Cell Science and Technology Co. Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ocular chemical burn is one of the causes of vision loss in China, and there are no&#xD;
      satisfactory treatment. Human umbilical cord mesenchymal stem cells(UC-MSCs) have the&#xD;
      biological characteristics of self-renewal, immune regulation, multidirectional&#xD;
      differentiation and tissue repair. Our preliminary research showed that in corneal alkali&#xD;
      injury rabbits, the UC-MSCs can accelerated the cornea repair, inhibited angiogenesis. The&#xD;
      aim of this study is to access the efficacy and safety of UC-MSCs in the treatment of corneal&#xD;
      burn in human.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2018</start_date>
  <completion_date type="Anticipated">June 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2018</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the percent of cornea perforation</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Ocular Corneal Burn</condition>
  <arm_group>
    <arm_group_label>group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>group 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>human umbilical cord mesenchymal stem cells</intervention_name>
    <description>human UC-MSCs: 0.2ml(about 2*10^6 cells) subconjunctival injection</description>
    <arm_group_label>group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>Saline injection</description>
    <arm_group_label>group 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  must be ocular burns including chemically burned or the thermally burned;&#xD;
&#xD;
          -  the subjects are willing to accept this research, and promise to coordinate with the&#xD;
             researchers during the follow up period;&#xD;
&#xD;
          -  the subjects should abide by the laws and rules of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  the visual acuity is blind in any of the eye;&#xD;
&#xD;
          -  have corneal perforation or have the corneal perforation tendency;&#xD;
&#xD;
          -  have been accepted surgery on eyeball after trauma;&#xD;
&#xD;
          -  IOP&gt;=25 mmHg even after antiglaucoma;&#xD;
&#xD;
          -  have the history of other corneal disease or surgery;&#xD;
&#xD;
          -  have the history of radiotherapy or surgery in the eyeball;&#xD;
&#xD;
          -  associated with corneal ulcer or endoophthalmitis;&#xD;
&#xD;
          -  uncontrolled hypertension(&gt;=150/95 mmHg);&#xD;
&#xD;
          -  abnormal liver and renal function;&#xD;
&#xD;
          -  the pregnant women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Wanling Chen</last_name>
    <phone>0086-20-37792600</phone>
    <email>chenwanling@saliai.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Jinan University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Yanyan Ma</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>August 1, 2017</last_update_submitted>
  <last_update_submitted_qc>August 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2017</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>Eye Burns</mesh_term>
    <mesh_term>Burns</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/NCT03237442
org study id: SSCST-MSC-OCB-01
nct id: NCT03237442
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Ocular chemical burn is one of the causes of vision loss in China, and there are no
      satisfactory treatment. Human umbilical cord mesenchymal stem cells(UC-MSCs) have the
      biological characteristics of self-renewal, immune regulation, multidirectional
      differentiation and tissue repair. Our preliminary research showed that in corneal alkali
      injury rabbits, the UC-MSCs can accelerated the cornea repair, inhibited angiogenesis. The
      aim of this study is to access the efficacy and safety of UC-MSCs in the treatment of corneal
      burn in human.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: the percent of cornea perforation
time frame: 3 months
arm group label: group 1
arm group type: Experimental
arm group label: group 2
arm group type: Active Comparator
intervention type: Biological
intervention name: human umbilical cord mesenchymal stem cells
description: human UC-MSCs: 0.2ml(about 2*10^6 cells) subconjunctival injection
arm group label: group 1
intervention type: Biological
intervention name: placebo
description: Saline injection
arm group label: group 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Wanling Chen
phone: 0086-20-37792600
email: chenwanling@saliai.com
facility: 
contact: 
country: China
responsible party type: Sponsor
mesh term: Eye Burns
mesh term: Burns