<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/NCT04426643</url>
  </required_header>
  <id_info>
    <org_study_id>IBCE_MSC(UIM)</org_study_id>
    <nct_id>NCT04426643</nct_id>
  </id_info>
  <brief_title>Treatment of Urinary Incontinence in Men After Prostatectomy With Autologous Adipose-derived Mesenchymal Stem Cells</brief_title>
  <official_title>Treatment of Urinary Incontinence in Men After Prostatectomy With Autologous Adipose-derived Mesenchymal Stem Cells Mixed With Collagen Gel and Injected Submucousely</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>The state institution N. N. Alexandrov National Cancer Centre of Belarus</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 urinary incontinence after prostatectomy using injection of&#xD;
      autologous adipose-derived mesenchymal stem cells mixed with collagen gel&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During the implementation of the project, it is planned to develop a method for the treatment&#xD;
      of men urinary incontinence caused by prostatectomy using injection of autologous&#xD;
      adipose-derived mesenchymal stem cells mixed with collagen. The positive outlook for the&#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 urinary&#xD;
           incontinence in animals.&#xD;
&#xD;
      In study planing to include 5 patients. MSCs will be isolated from adipose tissue, cultured&#xD;
      and then transplanted back to the periurethral area by five point injection in&#xD;
      rhabdosphincter and submucosal space of urethra using the cystourethroscope. For injection in&#xD;
      submucosal space MSCs (20*10^6 cells) will be mixed with collagen solution (3,5% w|w). Follow&#xD;
      up patients monitoring will occur at 1，3，6 and 12 months after injection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Actual">March 31, 2021</completion_date>
  <primary_completion_date type="Actual">February 20, 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>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>Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>mesenchymal stem cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with 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 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 injected in submucosal space</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;
          -  Urinary incontinence&#xD;
&#xD;
          -  absence of acute inflammatory manifestations in the genitourinary system&#xD;
&#xD;
          -  period after prostatectomy is at least 12 months&#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>Male</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, Dr</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 A Krasny, Dr</last_name>
    <role>Study Director</role>
    <affiliation>Deputy Director for Research of the National Cancer Centre</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>May 2021</verification_date>
  <study_first_submitted>June 7, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>May 24, 2021</last_update_submitted>
  <last_update_submitted_qc>May 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Urinary incontinence</keyword>
  <keyword>Prostatectomy</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>
  </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/NCT04426643
org study id: IBCE_MSC(UIM)
nct id: NCT04426643
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Treatment of patients with urinary incontinence after prostatectomy using injection of
      autologous adipose-derived mesenchymal stem cells mixed with collagen gel
During the implementation of the project, it is planned to develop a method for the treatment
      of men urinary incontinence caused by prostatectomy using injection of autologous
      adipose-derived mesenchymal stem cells mixed with collagen. The positive outlook for the
      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 urinary
           incontinence in animals.

      In study planing to include 5 patients. MSCs will be isolated from adipose tissue, cultured
      and then transplanted back to the periurethral area by five point injection in
      rhabdosphincter and submucosal space of urethra using the cystourethroscope. For injection in
      submucosal space MSCs (20*10^6 cells) will be mixed with collagen solution (3,5% w|w). Follow
      up patients monitoring will occur at 1，3，6 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 Urinary incontinence receiving standard treatment plus adipose-derived mesenchymal stem cells
arm group label: control
arm group type: Active Comparator
description: Patients with 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 injected in submucosal space
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: Male
minimum age: 18 Years
maximum age: 70 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
last name: Sergey A Krasny, Dr
role: Study Director
affiliation: Deputy Director for Research of the National Cancer Centre
facility: 
country: Belarus
responsible party type: Sponsor
mesh term: Urinary Incontinence
mesh term: Enuresis
sharing ipd: No