<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/NCT04446897</url>
  </required_header>
  <id_info>
    <org_study_id>IBCE_MSC(periodontitis)</org_study_id>
    <nct_id>NCT04446897</nct_id>
  </id_info>
  <brief_title>Treatment of Chronic Medium-severe Periodontitis With Mesenchymal Stem Cells Predifferentiated in Osteogenic Direction</brief_title>
  <official_title>Treatment of Chronic Medium-severe Periodontitis With Mesenchymal Stem Cells Predifferentiated in Osteogenic Direction Immobilised on a Biodegradable Carrier</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 Medical Academy of Post-Graduate Education</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 chronic medium-severe periodontitis with mesenchymal stem cells and mesenchymal&#xD;
      stem cells predifferentiated in osteogenic direction&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The bone defect will be filled with a porous membrane based on bone collagen measuring 5x5 mm&#xD;
      or more with mesenchymal stem cells and mesenchymal stem cells predifferentiated in&#xD;
      osteogenic direction&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 3, 2020</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</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 patients cured</measure>
    <time_frame>1 month</time_frame>
    <description>number of patients cured</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Periodontitis, Chronic</condition>
  <arm_group>
    <arm_group_label>mesenchymal stem cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>standard treatment according to clinical protocols plus mesenchymal stem cells</description>
  </arm_group>
  <arm_group>
    <arm_group_label>standard treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>standard treatment according to clinical protocols</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>mesenchymal stem cells</intervention_name>
    <description>autologous mesenchymal stem cells</description>
    <arm_group_label>mesenchymal stem cells</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>standard treatment</intervention_name>
    <description>standard treatment according to clinical protocols</description>
    <arm_group_label>mesenchymal stem cells</arm_group_label>
    <arm_group_label>standard treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - chronic medium-severe periodontitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  breast-feeding&#xD;
&#xD;
          -  acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis&#xD;
&#xD;
          -  mental disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>70 Years</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>Sergey Rubnikovich, Prof</last_name>
    <role>Study Director</role>
    <affiliation>Head of the Department of Prosthodontics of BMAPE</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>February 2021</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>February 8, 2021</last_update_submitted>
  <last_update_submitted_qc>February 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Periodontitis</keyword>
  <keyword>Mesenchymal stem cells</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Chronic Periodontitis</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/NCT04446897
org study id: IBCE_MSC(periodontitis)
nct id: NCT04446897
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Treatment of chronic medium-severe periodontitis with mesenchymal stem cells and mesenchymal
      stem cells predifferentiated in osteogenic direction
The bone defect will be filled with a porous membrane based on bone collagen measuring 5x5 mm
      or more with mesenchymal stem cells and mesenchymal stem cells predifferentiated in
      osteogenic direction
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: number of patients cured
time frame: 1 month
description: number of patients cured
arm group label: mesenchymal stem cells
arm group type: Experimental
description: standard treatment according to clinical protocols plus mesenchymal stem cells
arm group label: standard treatment
arm group type: Active Comparator
description: standard treatment according to clinical protocols
intervention type: Biological
intervention name: mesenchymal stem cells
description: autologous mesenchymal stem cells
arm group label: mesenchymal stem cells
intervention type: Other
intervention name: standard treatment
description: standard treatment according to clinical protocols
arm group label: mesenchymal stem cells
arm group label: standard treatment
criteria: 
gender: All
minimum age: 70 Years
maximum age: 70 Years
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: Sergey Rubnikovich, Prof
role: Study Director
affiliation: Head of the Department of Prosthodontics of BMAPE
facility: 
country: Belarus
responsible party type: Sponsor
mesh term: Periodontitis
mesh term: Chronic Periodontitis