<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/NCT04432467</url>
  </required_header>
  <id_info>
    <org_study_id>IBCE_MSC(Fertility)</org_study_id>
    <nct_id>NCT04432467</nct_id>
  </id_info>
  <brief_title>Fertility Restoration Using Autologous Mesenchymal Stem Cells</brief_title>
  <official_title>Fertility Restoration Using Autologous Adipose Tissue 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 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 the patients with scarring and adhesions in the uterus resulting from caesarean&#xD;
      section or chronic inflammation in the mucosa of the uterus and fallopian tubes and&#xD;
      preventing the occurrence of these effects in the future&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the project is to develop a biomedical cell product based on autologous adipose&#xD;
      tissue derived mesenchymal stem cells and a biodegradable carrier for highly effective&#xD;
      treatment and prevention of scarring and adhesions in the uterus acquired as a result of&#xD;
      cesarean section or chronic inflammatory processes in the uterine mucosa and fallopian tubes;&#xD;
      to conduct the clinical trials of the biomedical cell product in the treatment of uterus&#xD;
      scarring and infertility in women.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Actual">September 30, 2021</completion_date>
  <primary_completion_date type="Actual">September 30, 2021</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>6 months</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 application related adverse events assessed by blood count, liver and function tests</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Chronic Endometritis</condition>
  <condition>Uterus; Scar</condition>
  <condition>Uterine Synechiae</condition>
  <condition>Fallopian Tube Obstruction</condition>
  <arm_group>
    <arm_group_label>mesenchymal stem cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with impending caesarean section or with chronic inflammation in the mucosa of the uterus and fallopian tubes receiving standard treatment and mesenchymal 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 impending caesarean section or with chronic inflammation in the mucosa of the uterus and fallopian tubes receiving standard treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Autologous mesenchymal stem cells</intervention_name>
    <description>Autologous adipose tissue-derived 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>control</arm_group_label>
    <arm_group_label>mesenchymal stem cells</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  chronic endometritis&#xD;
&#xD;
          -  postoperative uterus scars&#xD;
&#xD;
          -  uterine synechia&#xD;
&#xD;
          -  fallopian tube obstruction&#xD;
&#xD;
          -  absence of acute inflammation in the uterus&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with genetic diseases of muscle and connective tissue;&#xD;
&#xD;
          -  Patients with malformations of the uterus;&#xD;
&#xD;
          -  Acute and chronic infectious diseases: HIV, mycoplasma infection, hepatitis B and C,&#xD;
             syphilis; autoimmune diseases; oncological diseases; continuous hormonal therapy with&#xD;
             cytostatics corticosteroids; acute noncommunicable diseases;&#xD;
&#xD;
          -  mental disorders;&#xD;
&#xD;
          -  Drug or alcohol addiction;&#xD;
&#xD;
          -  Benign tumors of uterus and appendages;&#xD;
&#xD;
          -  Hypersensitivity to any component of the studied biomedical cell product.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Igor D Volotovski, Dr</last_name>
    <role>Study Director</role>
    <affiliation>Head of the Lab of 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>December 2021</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>December 9, 2021</last_update_submitted>
  <last_update_submitted_qc>December 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fertility restoration</keyword>
  <keyword>Mesenchymal stem cells</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometritis</mesh_term>
    <mesh_term>Gynatresia</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/NCT04432467
org study id: IBCE_MSC(Fertility)
nct id: NCT04432467
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Treatment of the patients with scarring and adhesions in the uterus resulting from caesarean
      section or chronic inflammation in the mucosa of the uterus and fallopian tubes and
      preventing the occurrence of these effects in the future
The aim of the project is to develop a biomedical cell product based on autologous adipose
      tissue derived mesenchymal stem cells and a biodegradable carrier for highly effective
      treatment and prevention of scarring and adhesions in the uterus acquired as a result of
      cesarean section or chronic inflammatory processes in the uterine mucosa and fallopian tubes;
      to conduct the clinical trials of the biomedical cell product in the treatment of uterus
      scarring and infertility in women.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of cured patients
time frame: 6 months
description: Number of patients cured
measure: Number of patients with treatment-related adverse events
time frame: 4 weeks
description: MSC 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 impending caesarean section or with chronic inflammation in the mucosa of the uterus and fallopian tubes receiving standard treatment and mesenchymal stem cells
arm group label: control
arm group type: Active Comparator
description: Patients with impending caesarean section or with chronic inflammation in the mucosa of the uterus and fallopian tubes receiving standard treatment
intervention type: Biological
intervention name: Autologous mesenchymal stem cells
description: Autologous adipose tissue-derived 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: control
arm group label: mesenchymal stem cells
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Igor D Volotovski, Dr
role: Study Director
affiliation: Head of the Lab of Institute of Biophysics and Cell Engineering
facility: 
country: Belarus
responsible party type: Sponsor
mesh term: Endometritis
mesh term: Gynatresia
sharing ipd: No