<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/NCT03015779</url>
  </required_header>
  <id_info>
    <org_study_id>20161029</org_study_id>
    <nct_id>NCT03015779</nct_id>
  </id_info>
  <brief_title>Transplantation of Autologous Oral Mucosal Epithelial Stem Cell Sheet for Treating Limbal Stem Cell Deficiency Disease</brief_title>
  <official_title>Transplantation of Autologous Oral Mucosal Epithelial Stem Cell Sheet for Treating Limbal Stem Cell Deficiency Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>He Eye Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>He Eye Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this trials investigates the therapeutic effects of application autologous oral&#xD;
      mucosal epithelial cell sheets in the treatment of limbal stem cell deficiency disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A number of external factors can result in limbal stem cell deficiency(LSCD), causing pain,&#xD;
      pathological corneal epithelium regeneration, inflammation reaction and seriously visual&#xD;
      loss. For patients with unilaterally damaged eye, transplantation of limbal tissue from the&#xD;
      healthy eye can be used in the past years in the risk of inducing limbal stem cell damaged in&#xD;
      the healthy eye. While graft of human leukocyte antigen matched allogenic limbal stem cells&#xD;
      require immune suppressive medications, it can cause side effects in the body. Over the past&#xD;
      10 years, the clinical trials of application of cultured autologous oral mucosal epithelial&#xD;
      cell sheet to treat LSCD have been emerged as a promising strategy in many countries.&#xD;
      However, little study has been reported in China. This study investigates the therapeutic&#xD;
      effects of application autologous oral mucosal epithelial cell sheets in the treatment of&#xD;
      limbal stem cell deficiency disease in China.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The area of reepithelialization of corneal epithelium</measure>
    <time_frame>3 months</time_frame>
    <description>The preoperative status of the eye will be recorded on the basis of clinical drawings and pre-and post-operative photographs. These pictures will be sent to two corneal experts in order to evaluate the results.&#xD;
Judgement criterion: the results will be tested with a slit lamp:&#xD;
Normal: no epithelial loss; Mild: the area of epithelial loss &lt;1/3; Moderate: the area of epithelial loss &gt;1/3 &lt;2/3; Severe: the area of epithelial loss&gt; 2/3</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement of best correct visual acuity</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decrease of corneal neovascularization</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">7</enrollment>
  <condition>Limbal Stem Cell Deficiency</condition>
  <arm_group>
    <arm_group_label>experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>cultured autologous oral mucosal epithelial cell sheet</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>cultured autologous oral mucosal epithelial cell sheet</intervention_name>
    <description>a prospective study,Before and after self control</description>
    <arm_group_label>experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female aged&gt;=18 years old&#xD;
&#xD;
          -  Normal intraocular pressure&#xD;
&#xD;
          -  Normal Eyelid&#xD;
&#xD;
          -  No cataract and retinal disease&#xD;
&#xD;
          -  No ulcers and tumor in the mouth&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe Systemic infection&#xD;
&#xD;
          -  History of acute phase of ocular and oral inflammation&#xD;
&#xD;
          -  History of hyper sensibility or allergy to antibiotics or serum&#xD;
&#xD;
          -  Women who are or may be pregnant&#xD;
&#xD;
          -  Patients with infectious diseases&#xD;
&#xD;
          -  Patients with other complications&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>January 8, 2017</last_update_submitted>
  <last_update_submitted_qc>January 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 10, 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>Limbal Stem Cell Deficiency</mesh_term>
    <mesh_term>Deficiency Diseases</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/NCT03015779
org study id: 20161029
nct id: NCT03015779
lead sponsor: 
has dmc: No
The aim of this trials investigates the therapeutic effects of application autologous oral
      mucosal epithelial cell sheets in the treatment of limbal stem cell deficiency disease.
A number of external factors can result in limbal stem cell deficiency(LSCD), causing pain,
      pathological corneal epithelium regeneration, inflammation reaction and seriously visual
      loss. For patients with unilaterally damaged eye, transplantation of limbal tissue from the
      healthy eye can be used in the past years in the risk of inducing limbal stem cell damaged in
      the healthy eye. While graft of human leukocyte antigen matched allogenic limbal stem cells
      require immune suppressive medications, it can cause side effects in the body. Over the past
      10 years, the clinical trials of application of cultured autologous oral mucosal epithelial
      cell sheet to treat LSCD have been emerged as a promising strategy in many countries.
      However, little study has been reported in China. This study investigates the therapeutic
      effects of application autologous oral mucosal epithelial cell sheets in the treatment of
      limbal stem cell deficiency disease in China.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The area of reepithelialization of corneal epithelium
time frame: 3 months
description: The preoperative status of the eye will be recorded on the basis of clinical drawings and pre-and post-operative photographs. These pictures will be sent to two corneal experts in order to evaluate the results.
Judgement criterion: the results will be tested with a slit lamp:
Normal: no epithelial loss; Mild: the area of epithelial loss <1/3; Moderate: the area of epithelial loss >1/3 <2/3; Severe: the area of epithelial loss> 2/3
measure: Improvement of best correct visual acuity
time frame: one year
measure: Decrease of corneal neovascularization
time frame: one year
arm group label: experimental group
arm group type: Experimental
description: cultured autologous oral mucosal epithelial cell sheet
intervention type: Other
intervention name: cultured autologous oral mucosal epithelial cell sheet
description: a prospective study,Before and after self control
arm group label: experimental group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Limbal Stem Cell Deficiency
mesh term: Deficiency Diseases
sharing ipd: No