<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/NCT04483934</url>
  </required_header>
  <id_info>
    <org_study_id>IBCE_Fibr(TrophicUlcer)</org_study_id>
    <nct_id>NCT04483934</nct_id>
  </id_info>
  <brief_title>Treatment of Patients With Non-healing Wounds and Trophic Ulcers Using Autologous Dermal Fibroblasts</brief_title>
  <official_title>Treatment of Patients With Non-healing Wounds and Trophic Ulcers Using Local LED Phototherapy and Autologous Dermal Fibroblasts</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>Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology</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 non-healing wounds and trophic ulcers using local LED phototherapy&#xD;
      with local transplantation of autologous dermal fibroblasts&#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 dermal fibroblasts in the wound.&#xD;
&#xD;
      The positive outlook for the effectiveness of photodiode therapy with dermal fibroblasts is&#xD;
      due to the following:&#xD;
&#xD;
        -  the ability of fibroblasts to stimulate tissue regeneration&#xD;
&#xD;
        -  positive results of preclinical studies of the method of treatment of long-term&#xD;
           non-healing wounds in animals (rats).&#xD;
&#xD;
      Twelve patients were included in the study. Dermal fibroblasts were isolated from the skin&#xD;
      patients, cultured and then transplanted back to the wound.&#xD;
&#xD;
      The therapeutic dose of cells was 50k per cm2 of the wound area. Follow up patients&#xD;
      monitoring was performed at 1, 2 and more months after injection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 28, 2014</start_date>
  <completion_date type="Actual">September 30, 2016</completion_date>
  <primary_completion_date type="Actual">September 30, 2016</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>
    <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>Fibroblasts injection related adverse events assessed by blood count and function tests</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Trophic Ulcer</condition>
  <condition>Non-healing Wound</condition>
  <condition>Non-Healing Ulcer of Skin</condition>
  <arm_group>
    <arm_group_label>Patients treated with dermal fibroblasts</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cultured dermal fibroblasts and LED phototherepy</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Dermal fibroblasts</intervention_name>
    <description>Cultured autologous dermal fibroblasts.&#xD;
For PR: The name &quot;dermal fibroblasts&quot; is exactly the name of the cell product registered by our ministry of health. There is no trade or international name.</description>
    <arm_group_label>Patients treated with dermal fibroblasts</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LED phototherapy</intervention_name>
    <description>LED phototherapy</description>
    <arm_group_label>Patients treated with dermal fibroblasts</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Trophic Ulcers&#xD;
&#xD;
          -  Chronic non-healing wounds&#xD;
&#xD;
        Exclusion Criteria:&#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>N/A</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>Stanislav Tretyak, Prof</last_name>
    <role>Study Director</role>
    <affiliation>Head of 2nd Department of Surgical Diseases of BSMU</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Evgeny Baranov, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ass prof of 2nd Department of Surgical Diseases of BSMU</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zinaida Kvacheva, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lead Researcher 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>July 2020</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Trophic Ulcer</keyword>
  <keyword>Non-healing Wound</keyword>
  <keyword>Dermal fibroblasts</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ulcer</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT04483934
org study id: IBCE_Fibr(TrophicUlcer)
nct id: NCT04483934
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Treatment of patients with non-healing wounds and trophic ulcers using local LED phototherapy
      with local transplantation of autologous dermal fibroblasts
During the implementation of the project, it was planned to develop a method for the
      treatment of trophic ulcers using injection of autologous dermal fibroblasts in the wound.

      The positive outlook for the effectiveness of photodiode therapy with dermal fibroblasts is
      due to the following:

        -  the ability of fibroblasts to stimulate tissue regeneration

        -  positive results of preclinical studies of the method of treatment of long-term
           non-healing wounds in animals (rats).

      Twelve patients were included in the study. Dermal fibroblasts were isolated from the skin
      patients, cultured and then transplanted back to the wound.

      The therapeutic dose of cells was 50k per cm2 of the wound area. Follow up patients
      monitoring was performed at 1, 2 and more months after injection.
allocation: N/A
intervention model: Single Group Assignment
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: Fibroblasts injection related adverse events assessed by blood count and function tests
arm group label: Patients treated with dermal fibroblasts
arm group type: Experimental
description: Cultured dermal fibroblasts and LED phototherepy
intervention type: Biological
intervention name: Dermal fibroblasts
description: Cultured autologous dermal fibroblasts.
For PR: The name "dermal fibroblasts" is exactly the name of the cell product registered by our ministry of health. There is no trade or international name.
arm group label: Patients treated with dermal fibroblasts
intervention type: Device
intervention name: LED phototherapy
description: LED phototherapy
arm group label: Patients treated with dermal fibroblasts
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
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: Stanislav Tretyak, Prof
role: Study Director
affiliation: Head of 2nd Department of Surgical Diseases of BSMU
last name: Evgeny Baranov, Dr
role: Principal Investigator
affiliation: Ass prof of 2nd Department of Surgical Diseases of BSMU
last name: Zinaida Kvacheva, Dr
role: Principal Investigator
affiliation: Lead Researcher of Institute of Biophysics and Cell Engineering
facility: 
country: Belarus
responsible party type: Sponsor
mesh term: Ulcer
mesh term: Wounds and Injuries
sharing ipd: No