<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/NCT04484402</url>
  </required_header>
  <id_info>
    <org_study_id>IBCE_LSC</org_study_id>
    <nct_id>NCT04484402</nct_id>
  </id_info>
  <brief_title>Treatment of Patients With Inflammatory-dystrophic Diseases of the Cornea Using Autologous Stem Cells</brief_title>
  <official_title>Treatment of Patients With Inflammatory-dystrophic Diseases of the Cornea Using Autologous Limbal Stem Cells (Corneal Epithelial Stem Cells) or Adipose-derived Mesenchymal Stem Cells</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Belarusian State Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus</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>
      Treatment of patients with inflammatory-dystrophic diseases of the cornea using autologous&#xD;
      limbal stem cells (corneal epithelial stem cells) or adipose-derived mesenchymal stem cells&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In order to treat inflammatory and dystrophic diseases of the cornea perilimbal injections of&#xD;
      cultured autologous stem cells are performed. Corneal (limbal) epithelial stem cells (LSC) or&#xD;
      mesenchymal stem cells derived from adipose tissue (ADSC) are mixed with sodium hyaluronate&#xD;
      1%&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 3, 2016</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">December 30, 2019</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>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of cured patients</measure>
    <time_frame>2 month</time_frame>
    <description>Number of patients cured</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with treatment-related adverse events</measure>
    <time_frame>4 weeks</time_frame>
    <description>MSC/LSC application related adverse events assessed by blood count, liver and function tests</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Corneal Ulcer</condition>
  <condition>Corneal Disease</condition>
  <condition>Corneal Dystrophy</condition>
  <arm_group>
    <arm_group_label>mesenchymal stem cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment plus adipose-derived mesenchymal stem cells</description>
  </arm_group>
  <arm_group>
    <arm_group_label>limbal stem cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment plus adipose-derived limbal stem cells</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>mesenchymal stem cells</intervention_name>
    <description>Autologous adipose-derived mesenchymal stem cells mixed with sodium hyaluronate 1% solution</description>
    <arm_group_label>mesenchymal stem cells</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>limbal stem cells</intervention_name>
    <description>Autologous adipose-derived limbal stem cells mixed with sodium hyaluronate 1% solution</description>
    <arm_group_label>limbal stem cells</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>standard treatment</intervention_name>
    <description>Standard treatment according to the Clinical protocols</description>
    <arm_group_label>control</arm_group_label>
    <arm_group_label>limbal stem cells</arm_group_label>
    <arm_group_label>mesenchymal stem cells</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  inflammatory-dystrophic diseases of the cornea:&#xD;
&#xD;
               1. Epithelial defects of the cornea, ulcerative keratitis of various etiology,&#xD;
                  resistant to standard methods of treatment&#xD;
&#xD;
               2. Dystrophic diseases of the cornea, accompanied by edema&#xD;
&#xD;
               3. Burns of the cornea&#xD;
&#xD;
               4. Neurotrophic forms of keratitis&#xD;
&#xD;
               5. Persistent post-traumatic, postoperative, contusion keratitis and keratopathy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy.&#xD;
&#xD;
          2. Viral hepatitis B and C, HIV, tubeculosis and other chronic viral and bacterial&#xD;
             infections.&#xD;
&#xD;
          3. Cancer or leukemia&#xD;
&#xD;
          4. Any diseases in the stage of decompensation.&#xD;
&#xD;
          5. Mental disorders.&#xD;
&#xD;
          6. Anomalies of eye refraction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Igor Volotovski, Prof</last_name>
    <role>Study Director</role>
    <affiliation>Head of the Lab of Institute of Biophysics and Cell Engineering</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Liudmila Marchenko, Prof</last_name>
    <role>Study Director</role>
    <affiliation>Head of the Department of eyes diseases of Belarusian State Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zinaida Kvacheva</last_name>
    <role>Principal Investigator</role>
    <affiliation>Leading researcher, Institute of Biophysics and Cell Engineering</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus</name>
      <address>
        <city>Minsk</city>
        <zip>220072</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belarus</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Corneal Disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Corneal Ulcer</mesh_term>
    <mesh_term>Corneal Dystrophies, Hereditary</mesh_term>
    <mesh_term>Corneal 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/NCT04484402
org study id: IBCE_LSC
nct id: NCT04484402
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Treatment of patients with inflammatory-dystrophic diseases of the cornea using autologous
      limbal stem cells (corneal epithelial stem cells) or adipose-derived mesenchymal stem cells
In order to treat inflammatory and dystrophic diseases of the cornea perilimbal injections of
      cultured autologous stem cells are performed. Corneal (limbal) epithelial stem cells (LSC) or
      mesenchymal stem cells derived from adipose tissue (ADSC) are mixed with sodium hyaluronate
      1%
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of cured patients
time frame: 2 month
description: Number of patients cured
measure: Number of patients with treatment-related adverse events
time frame: 4 weeks
description: MSC/LSC application related adverse events assessed by blood count, liver and function tests
arm group label: mesenchymal stem cells
arm group type: Experimental
description: Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment plus adipose-derived mesenchymal stem cells
arm group label: limbal stem cells
arm group type: Experimental
description: Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment plus adipose-derived limbal stem cells
arm group label: control
arm group type: Active Comparator
description: Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment
intervention type: Biological
intervention name: mesenchymal stem cells
description: Autologous adipose-derived mesenchymal stem cells mixed with sodium hyaluronate 1% solution
arm group label: mesenchymal stem cells
intervention type: Biological
intervention name: limbal stem cells
description: Autologous adipose-derived limbal stem cells mixed with sodium hyaluronate 1% solution
arm group label: limbal stem cells
intervention type: Other
intervention name: standard treatment
description: Standard treatment according to the Clinical protocols
arm group label: control
arm group label: limbal stem cells
arm group label: mesenchymal stem cells
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Igor Volotovski, Prof
role: Study Director
affiliation: Head of the Lab of Institute of Biophysics and Cell Engineering
last name: Liudmila Marchenko, Prof
role: Study Director
affiliation: Head of the Department of eyes diseases of Belarusian State Medical University
last name: Zinaida Kvacheva
role: Principal Investigator
affiliation: Leading researcher, Institute of Biophysics and Cell Engineering
facility: 
country: Belarus
responsible party type: Sponsor
mesh term: Corneal Ulcer
mesh term: Corneal Dystrophies, Hereditary
mesh term: Corneal Diseases
sharing ipd: No