<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/NCT04457037</url>
  </required_header>
  <id_info>
    <org_study_id>IBCE_MSC(TrophicUlcer)</org_study_id>
    <nct_id>NCT04457037</nct_id>
  </id_info>
  <brief_title>Treatment of Patients With Trophic Ulcers Using Mesenchymal Stem Cells</brief_title>
  <official_title>Treatment of Patients With Trophic Ulcers Using Autologous 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 trophic ulcers using injection of autologous adipose-derived&#xD;
      mesenchymal stem cells around and inside the wound&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During the implementation of the project, it was planned to develop a method for the&#xD;
      treatment of trophic ulcers using injection of autologous adipose-derived mesenchymal stem&#xD;
      cells in the wound. The positive outlook for the effectiveness of MSCs is due to the&#xD;
      following:&#xD;
&#xD;
        -  the ability of MSCs to stimulate tissue regeneration&#xD;
&#xD;
        -  positive results of preclinical studies of the method of treatment of trophic ulcers in&#xD;
           animals (rats).&#xD;
&#xD;
      In study were included 18 patients (28 trophic ulcers treated). MSCs will be isolated from&#xD;
      adipose tissue, cultured and then transplanted back to the wound. From 1 to 10 million MSCs&#xD;
      in 4 ml were injected depending on the area of the wound. Follow up patients monitoring will&#xD;
      occur at 1，2 and 3, 6, 12, 22 months after injection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2009</start_date>
  <completion_date type="Actual">December 31, 2013</completion_date>
  <primary_completion_date type="Actual">December 31, 2013</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>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Patients with trophic ulcers received standard treatment and mesenchymal stem cells</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with tropic ulcers cured</measure>
    <time_frame>1 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 injection related adverse events assessed by blood count and function tests</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Trophic Ulcer</condition>
  <arm_group>
    <arm_group_label>MSC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with trophic ulcers received standard treatment and MSC</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</description>
    <arm_group_label>MSC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Trophic Ulcers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  diagnosed cancer&#xD;
&#xD;
          -  acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis&#xD;
&#xD;
          -  mental disorders&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Igor 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>Stanislav Tretyak, Prof</last_name>
    <role>Study Director</role>
    <affiliation>Head of 2 Department of Surgical Diseases of BSMU</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>June 2020</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Trophic Ulcer</keyword>
  <keyword>Mesenchymal stem cells</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ulcer</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/NCT04457037
org study id: IBCE_MSC(TrophicUlcer)
nct id: NCT04457037
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Treatment of patients with trophic ulcers using injection of autologous adipose-derived
      mesenchymal stem cells around and inside the wound
During the implementation of the project, it was planned to develop a method for the
      treatment of trophic ulcers using injection of autologous adipose-derived mesenchymal stem
      cells in the wound. 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 trophic ulcers in
           animals (rats).

      In study were included 18 patients (28 trophic ulcers treated). MSCs will be isolated from
      adipose tissue, cultured and then transplanted back to the wound. From 1 to 10 million MSCs
      in 4 ml were injected depending on the area of the wound. Follow up patients monitoring will
      occur at 1，2 and 3, 6, 12, 22 months after injection.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Patients with trophic ulcers received standard treatment and mesenchymal stem cells
primary purpose: Treatment
masking: None (Open Label)
measure: Number of patients with tropic ulcers cured
time frame: 1 month
description: Number of patients cured
measure: Number of patients with treatment-related adverse events
time frame: 4 weeks
description: MSC injection related adverse events assessed by blood count and function tests
arm group label: MSC
arm group type: Experimental
description: Patients with trophic ulcers received standard treatment and MSC
intervention type: Biological
intervention name: Autologous adipose-derived mesenchymal stem cells
description: Autologous adipose-derived mesenchymal stem cells
arm group label: MSC
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Igor Volotovski, Dr
role: Study Director
affiliation: Head of the Lab of Institute of Biophysics and Cell Engineering
last name: Stanislav Tretyak, Prof
role: Study Director
affiliation: Head of 2 Department of Surgical Diseases of BSMU
facility: 
country: Belarus
responsible party type: Sponsor
mesh term: Ulcer
sharing ipd: No