<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/NCT04446884</url>
  </required_header>
  <id_info>
    <org_study_id>IBCE_MSC(UIW)</org_study_id>
    <nct_id>NCT04446884</nct_id>
  </id_info>
  <brief_title>Treatment of Stress Urinary Incontinence in Women With Autologous Adipose-derived Mesenchymal Stem Cells</brief_title>
  <official_title>Treatment of Stress Urinary Incontinence in Women With Autologous Adipose-derived Mesenchymal Stem Cells Mixed With Collagen Gel</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>
  </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 women with stress urinary incontinence using injection of autologous&#xD;
      adipose-derived mesenchymal stem cells mixed with collagen gel&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During the implementation of the project, method for the treatment of women stress urinary&#xD;
      incontinence using injection of autologous adipose-derived mesenchymal stem cells mixed with&#xD;
      collagen was developed.&#xD;
&#xD;
      Effectiveness of MSCs is due to the following:&#xD;
&#xD;
        -  the ability of MSCs to stimulate tissue regeneration&#xD;
&#xD;
        -  positive results of preclinical studies of the method of treatment of stress urinary&#xD;
           incontinence (SUI) in animals (female rats).&#xD;
&#xD;
      After gynecological examination, diagnosis of SUI, MSCs were isolated from adipose tissue,&#xD;
      cultured and then transplanted back to directly under mucosa of urethra by three point&#xD;
      injection in one third distal from the urethral neck at 3, 6 and 9 o'clock and to the&#xD;
      paraurethral area.&#xD;
&#xD;
      Injected volume was 3 ml per patient. For injection MSCs (6*10^6 cells) were mixed with&#xD;
      collagen solution (3,5% w|w).&#xD;
&#xD;
      Follow up patients monitoring was mperformed at 2, 4, 6 and 12 months after injection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 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>3 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>Stress Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>mesenchymal stem cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with Stress urinary incontinence receiving standard treatment plus adipose-derived 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 Stress urinary incontinence receiving standard treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Autologous adipose-derived mesenchymal stem cells</intervention_name>
    <description>Autologous adipose-derived mesenchymal stem cells mixed with collagen solution</description>
    <arm_group_label>mesenchymal stem cells</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard treatment according to the Clinical protocols</intervention_name>
    <description>Standard treatment according to the 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;
          -  Stress urinary incontinence&#xD;
&#xD;
          -  absence of acute inflammatory manifestations in the genitourinary system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  urethral or bladder malformations&#xD;
&#xD;
          -  acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis&#xD;
&#xD;
          -  mental disorders&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Igor D 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>Alexander Nechiporenko, Dr</last_name>
    <role>Study Director</role>
    <affiliation>Associate Professor of Department of Surgical Diseases</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hrodna City Clinical Hospital</name>
      <address>
        <city>Hrodna</city>
        <zip>230009</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belarus</country>
  </location_countries>
  <verification_date>June 2020</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>June 22, 2020</last_update_submitted>
  <last_update_submitted_qc>June 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stress Urinary Incontinence</keyword>
  <keyword>Mesenchymal stem cells</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Enuresis</mesh_term>
    <mesh_term>Urinary Incontinence, Stress</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/NCT04446884
org study id: IBCE_MSC(UIW)
nct id: NCT04446884
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Treatment of women with stress urinary incontinence using injection of autologous
      adipose-derived mesenchymal stem cells mixed with collagen gel
During the implementation of the project, method for the treatment of women stress urinary
      incontinence using injection of autologous adipose-derived mesenchymal stem cells mixed with
      collagen was developed.

      Effectiveness of MSCs is due to the following:

        -  the ability of MSCs to stimulate tissue regeneration

        -  positive results of preclinical studies of the method of treatment of stress urinary
           incontinence (SUI) in animals (female rats).

      After gynecological examination, diagnosis of SUI, MSCs were isolated from adipose tissue,
      cultured and then transplanted back to directly under mucosa of urethra by three point
      injection in one third distal from the urethral neck at 3, 6 and 9 o'clock and to the
      paraurethral area.

      Injected volume was 3 ml per patient. For injection MSCs (6*10^6 cells) were mixed with
      collagen solution (3,5% w|w).

      Follow up patients monitoring was mperformed at 2, 4, 6 and 12 months after injection.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of cured patients
time frame: 3 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 Stress urinary incontinence receiving standard treatment plus adipose-derived mesenchymal stem cells
arm group label: control
arm group type: Active Comparator
description: Patients with Stress urinary incontinence receiving standard treatment
intervention type: Biological
intervention name: Autologous adipose-derived mesenchymal stem cells
description: Autologous adipose-derived mesenchymal stem cells mixed with collagen solution
arm group label: mesenchymal stem cells
intervention type: Other
intervention name: Standard treatment according to the Clinical protocols
description: Standard treatment according to the Clinical protocols
arm group label: control
arm group label: mesenchymal stem cells
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Igor D Volotovski, Prof
role: Study Director
affiliation: Head of the Lab of Institute of Biophysics and Cell Engineering
last name: Alexander Nechiporenko, Dr
role: Study Director
affiliation: Associate Professor of Department of Surgical Diseases
facility: 
country: Belarus
responsible party type: Sponsor
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Urinary Incontinence, Stress
sharing ipd: No