xml: <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/NCT05962931</url>
    </required_header>
    <id_info>
      <org_study_id>UV/AP/21</org_study_id>
      <nct_id>NCT05962931</nct_id>
    </id_info>
    <brief_title>Clinical Trial With Adipose Tissue Stem Cells on Biological Matrix for the Treatment of Venous Ulcer of the Lower Limbs</brief_title>
    <official_title>Phase I-II, Multicenter, Randomized, Controlled, Proof of Concept Clinical Trial to Determine Feasibility, Safety and Efficacy of the Use of Allogenic Adipose-derived Adult Mesenchymal Stem Cells Expanded on Fibrinhyaluronic Biological Matrix in the Treatment of Venous Ulcer of the Lower Limbs</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Andalusian Network for Design and Translation of Advanced Therapies</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Andalusian Network for Design and Translation of Advanced Therapies</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Phase I-II, Multicenter, Randomized, Controlled, Proof of Concept Clinical Trial to determine&#xD;
        feasibility, safety and efficacy of the use of Allogenic adipose-derived adult mesenchymal&#xD;
        stem cells expanded on fibrinhyaluronic biological matrix in the treatment of venous ulcer of&#xD;
        the lower limbs.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 12, 2023</start_date>
    <completion_date type="Anticipated">July 2025</completion_date>
    <primary_completion_date type="Anticipated">July 2025</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>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Factibility of Bioengineered Artificial Mesenchimal Sheet measured as the remission of the treated fistula.</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>To evaluate the factibility of the topical application of CMTAd in a biological matrix of fibrin-hyaluronic acid on venous ulcers (VU).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Safety of Bioengineered Artificial Mesenchimal Sheet measured by the incidence of adverse events</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>To examine the safety of cutaneous administration of CMTAd in a biological matrix of fibrin-hyaluronic acid on VUs compared to standard treatment.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Venous Ulcer</condition>
    <arm_group>
      <arm_group_label>Bioengineered Artificial Mesenchimal Sheet (BAMS)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Allogenic adipose-derived adult mesenchymal stem cells expanded on fibrinhyaluronic biological matrix</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard treatment (Control)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Standard treatment</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Bioengineered Artificial Mesenchimal Sheet (BAMS)</intervention_name>
      <description>Each patient assigned to the experimental treatment group will receive 4 BAMS (1 BAMS/week) at a concentration of about 360,000 cells/cm2.</description>
      <arm_group_label>Bioengineered Artificial Mesenchimal Sheet (BAMS)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Standard treatment (Control)</intervention_name>
      <description>Each patient assigned to the control group will undergo a standard treatment procedure for uncomplicated venous ulcers.</description>
      <arm_group_label>Standard treatment (Control)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Signing of the informed consent (IC) after reading the patient information sheet.&#xD;
  &#xD;
            2. Over 18 years of both sexes.&#xD;
  &#xD;
            3. Active or recurrent venous ulcer in the lower extremity with an area between 5-10 cm2&#xD;
  &#xD;
            4. Grade III injury on the Widmer scale.&#xD;
  &#xD;
            5. Independence and/or availability to go to the referral center on an outpatient basis.&#xD;
  &#xD;
            6. Distal pulses in palpable lower limbs (tibial and foot). ABI between 0.8 - 1.3&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Any pathology for which the investigator considers that compression bandaging is&#xD;
               contraindicated and/or previous acute deep vein thrombosis (DVT), within the first 10&#xD;
               days from the onset of symptoms.&#xD;
  &#xD;
            2. Grade III obesity with a body mass index (BMI) &gt;40; or underweight patients (BMI&#xD;
               &lt;18.5).&#xD;
  &#xD;
            3. Active neoplasia and/or being treated with cytostatics.&#xD;
  &#xD;
            4. Patients undergoing radiotherapy treatment in areas close to the lesion.&#xD;
  &#xD;
            5. Clinical signs of colonization or local infection of the lesion.&#xD;
  &#xD;
            6. Patients with more than one lesion compatible with UV in the same lower limb.&#xD;
  &#xD;
            7. Erysipelas.&#xD;
  &#xD;
            8. Infectious cellulite.&#xD;
  &#xD;
            9. Osteomyelitis.&#xD;
  &#xD;
           10. Lymphangitis.&#xD;
  &#xD;
           11. Chronic lymphedema.&#xD;
  &#xD;
           12. Therapy with corticosteroids or immunosuppressants.&#xD;
  &#xD;
           13. Venous ulcer grade I or II on the Widmer scale.&#xD;
  &#xD;
           14. Lesions close to possible or diagnosed cancerous lesions.&#xD;
  &#xD;
           15. Non-localized wounds in the lower extremities.&#xD;
  &#xD;
           16. Ongoing infection and/or sepsis.&#xD;
  &#xD;
           17. Critical ischemia in the lower limbs or other venous diseases of unknown origin.&#xD;
  &#xD;
           18. Immunocompromised patients.&#xD;
  &#xD;
           19. Dependent patients with severe mobility limitations.&#xD;
  &#xD;
           20. Dialysis patients.&#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>Encarnación González Vigil</last_name>
      <role>Principal Investigator</role>
      <affiliation>Unidad de A.P. de Atarfe</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Mª Ángeles Granado Contrelas</last_name>
      <role>Principal Investigator</role>
      <affiliation>Unidad de A.P. de Alfacar</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Victor Costela Ruiz</last_name>
      <role>Study Director</role>
      <affiliation>Universidad de Granada</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Olga Férnández López, PhD</last_name>
      <phone>955 048 366</phone>
      <phone_ext>0034</phone_ext>
      <email>ensayosclinicos.radytta.fps@juntadeandalucia.es</email>
    </overall_contact>
    <location>
      <facility>
        <name>Unidad de A.P. de Alfacar</name>
        <address>
          <city>Alfacar</city>
          <state>Granada</state>
          <zip>18170</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mª Ángeles Granado Contrelas</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Unidad de A.P. de Atarfe</name>
        <address>
          <city>Atarfe</city>
          <state>Granada</state>
          <zip>18290</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Encarnación González Vigil</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Universidad de Granada</name>
        <address>
          <city>Granada</city>
          <zip>18071</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Victor Costela Ruiz</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 6, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Varicose Ulcer</mesh_term>
      <mesh_term>Ulcer</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05962931
  org study id: UV/AP/21
  nct id: NCT05962931
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Phase I-II, Multicenter, Randomized, Controlled, Proof of Concept Clinical Trial to determine
        feasibility, safety and efficacy of the use of Allogenic adipose-derived adult mesenchymal
        stem cells expanded on fibrinhyaluronic biological matrix in the treatment of venous ulcer of
        the lower limbs.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Factibility of Bioengineered Artificial Mesenchimal Sheet measured as the remission of the treated fistula.
  time frame: Through study completion, an average of 1 year
  description: To evaluate the factibility of the topical application of CMTAd in a biological matrix of fibrin-hyaluronic acid on venous ulcers (VU).
  measure: Safety of Bioengineered Artificial Mesenchimal Sheet measured by the incidence of adverse events
  time frame: Through study completion, an average of 1 year
  description: To examine the safety of cutaneous administration of CMTAd in a biological matrix of fibrin-hyaluronic acid on VUs compared to standard treatment.
  arm group label: Bioengineered Artificial Mesenchimal Sheet (BAMS)
  arm group type: Experimental
  description: Allogenic adipose-derived adult mesenchymal stem cells expanded on fibrinhyaluronic biological matrix
  arm group label: Standard treatment (Control)
  arm group type: Active Comparator
  description: Standard treatment
  intervention type: Biological
  intervention name: Bioengineered Artificial Mesenchimal Sheet (BAMS)
  description: Each patient assigned to the experimental treatment group will receive 4 BAMS (1 BAMS/week) at a concentration of about 360,000 cells/cm2.
  arm group label: Bioengineered Artificial Mesenchimal Sheet (BAMS)
  intervention type: Procedure
  intervention name: Standard treatment (Control)
  description: Each patient assigned to the control group will undergo a standard treatment procedure for uncomplicated venous ulcers.
  arm group label: Standard treatment (Control)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Encarnación González Vigil
  role: Principal Investigator
  affiliation: Unidad de A.P. de Atarfe
  last name: Mª Ángeles Granado Contrelas
  role: Principal Investigator
  affiliation: Unidad de A.P. de Alfacar
  last name: Victor Costela Ruiz
  role: Study Director
  affiliation: Universidad de Granada
  last name: Olga Férnández López, PhD
  phone: 955 048 366
  phone ext: 0034
  email: ensayosclinicos.radytta.fps@juntadeandalucia.es
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: Spain
  responsible party type: Sponsor
  mesh term: Varicose Ulcer
  mesh term: Ulcer