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/NCT06003530</url>
    </required_header>
    <id_info>
      <org_study_id>Cyt DFU hOMSC200</org_study_id>
      <nct_id>NCT06003530</nct_id>
    </id_info>
    <brief_title>Study for Treatment of Chronic Diabetic Foot Ulcers With the Investigational Allogeneic Cell Therapy Product, hOMSC200</brief_title>
    <official_title>Phase 1/2a Study for Treatment of Chronic Diabetic Foot Ulcers (DFU) With the Investigational Allogeneic Cell Therapy Product, hOMSC200</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cytora Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cytora Ltd.</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>
        Purpose of this phase 1/2a study is to assess the safety and efficacy of administration of&#xD;
        allogeneic human oral mucosal stem cells (hOMSCs) in patients suffering from chronic diabetic&#xD;
        foot ulcers (DFU).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A prospective, placebo controlled, partially blinded and randomized study, comprising two&#xD;
        hOMSC200 dose groups (low &amp; high) and one placebo treated group of DFU patients (3 groups;&#xD;
        n=8 / treatment groups and n=6/ control group).&#xD;
  &#xD;
        Study employs a 2+2 design for dose escalation. The first two patients recruited were treated&#xD;
        with a low dose, in a staggered manner, followed by two patients who were recruited to&#xD;
        receive the high dose. The remaining patients (18) are randomized to receive the low dose,&#xD;
        high dose, or placebo treatment. The assessors and patients will be blinded to the study&#xD;
        treatments.&#xD;
  &#xD;
        Following administration of hOMSC200 or placebo patients will attend on-site follow up visits&#xD;
        for 6 months. During this period safety profile of the investigational product will be&#xD;
        assessed as well as measurement of ulcer size. All patients, irrespective of allocated&#xD;
        treatment, will receive routine standard of care.&#xD;
  &#xD;
        Patients will be followed for long term safety with a phone call interview 1 year following&#xD;
        the 6 months termination visit. Optional on-site follow up visits will be offered to all&#xD;
        patients during this time period.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 6, 2022</start_date>
    <completion_date type="Anticipated">November 2024</completion_date>
    <primary_completion_date type="Anticipated">November 2023</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>
      <intervention_model_description>Patients will be allocated to one of the following arms: Low dose single administration of hOMSC200, High dose single administration of hOMSC200 or Placebo (control) all in addition to SOC treatment</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Treatment related adverse events</measure>
      <time_frame>6 months</time_frame>
      <description>Occurrence of treatment-related adverse events assessed by common terminology criteria for adverse events (CTCAE) following recruitment, hOMSC200 administration (ID), and during the follow up.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Wound healing</measure>
      <time_frame>24 weeks</time_frame>
      <description>Percentage of wound surface area reduction</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">22</enrollment>
    <condition>Diabetic Foot</condition>
    <condition>Diabetic Foot Ulcer</condition>
    <condition>Diabetic Foot Ulcer Neuropathic</condition>
    <arm_group>
      <arm_group_label>Low dose hOMSC200</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Administration of low dose hOMSC200 in addition to routine standard of care</description>
    </arm_group>
    <arm_group>
      <arm_group_label>High dose hOMSC200</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Administration of high dose hOMSC200 in addition to routine standard of care</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Administration of placebo in addition to routine standard of care</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>hOMSC200</intervention_name>
      <description>Human Oral Mucosal Stem Cells</description>
      <arm_group_label>High dose hOMSC200</arm_group_label>
      <arm_group_label>Low dose hOMSC200</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Animal component-free, defined cryopreservation medium with 5% DMSO</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosed with Type I or Type 2diabetes and with a neuropathic diabetic foot ulcer for&#xD;
               longer than 8 weeks.&#xD;
  &#xD;
            -  Size of foot ulcer 0.5-13 cm2&#xD;
  &#xD;
            -  Ulcer graded I by Wager scale&#xD;
  &#xD;
            -  Ulcer is free of necrotic debris, exhibits no signs of clinical infection&#xD;
  &#xD;
            -  Ulcer area blood circulation meets one of the following criteria: A. Palpable tibialis&#xD;
               anterior and posterior arteries in the affected foot; B. ABI range &gt;0.7 to &lt;1.3; C.&#xD;
               TcPO2&gt;30mmHg&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Ulcer is of non-diabetic pathophysiology&#xD;
  &#xD;
            -  The ulcer has decreased in size by &gt;=30% after the screening visit (week -2 to -4&#xD;
               before treatment)&#xD;
  &#xD;
            -  Severe hepatic deficiency&#xD;
  &#xD;
            -  Glycated hemoglobin A1C (HbA1C) level of &gt;12%&#xD;
  &#xD;
            -  Postprandial blood sugar &gt; 350mg/dl&#xD;
  &#xD;
            -  Require antibiotics to treat the target wound infection within 14 days prior to&#xD;
               treatment&#xD;
  &#xD;
            -  Evidence of current wound infection including pus drainage from wound site&#xD;
  &#xD;
            -  Severe renal failure (GFR&lt;30) including subject on renal dialysis&#xD;
  &#xD;
            -  Pregnant or breastfeeding&#xD;
  &#xD;
            -  Was receiving oral or parenteral corticosteroids, immunosuppressives, or cytotoxic&#xD;
               agents prior to 4 weeks from screening&#xD;
  &#xD;
            -  Patient receiving anticoagulation therapy except for aspirin&#xD;
  &#xD;
            -  Underwent wound treatments with growth factors, dermal substitutes, or other&#xD;
               biological therapies within the last 30 days prior to screening visit&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Shaare Zedek Medical Center</name>
        <address>
          <city>Jerusalem</city>
          <zip>9103102</zip>
          <country>Israel</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Matitiau Z Noff, MD</last_name>
        <phone>972-52-2550505</phone>
        <email>mnoff@szmc.org.il</email>
      </contact>
      <investigator>
        <last_name>Matitiau Z Noff, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Israel</country>
    </location_countries>
    <verification_date>February 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>diabetic foot ulcer</keyword>
    <keyword>stem cells</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetic Foot</mesh_term>
      <mesh_term>Foot 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/NCT06003530
  org study id: Cyt DFU hOMSC200
  nct id: NCT06003530
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Purpose of this phase 1/2a study is to assess the safety and efficacy of administration of
        allogeneic human oral mucosal stem cells (hOMSCs) in patients suffering from chronic diabetic
        foot ulcers (DFU).
  A prospective, placebo controlled, partially blinded and randomized study, comprising two
        hOMSC200 dose groups (low & high) and one placebo treated group of DFU patients (3 groups;
        n=8 / treatment groups and n=6/ control group).
  
        Study employs a 2+2 design for dose escalation. The first two patients recruited were treated
        with a low dose, in a staggered manner, followed by two patients who were recruited to
        receive the high dose. The remaining patients (18) are randomized to receive the low dose,
        high dose, or placebo treatment. The assessors and patients will be blinded to the study
        treatments.
  
        Following administration of hOMSC200 or placebo patients will attend on-site follow up visits
        for 6 months. During this period safety profile of the investigational product will be
        assessed as well as measurement of ulcer size. All patients, irrespective of allocated
        treatment, will receive routine standard of care.
  
        Patients will be followed for long term safety with a phone call interview 1 year following
        the 6 months termination visit. Optional on-site follow up visits will be offered to all
        patients during this time period.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Patients will be allocated to one of the following arms: Low dose single administration of hOMSC200, High dose single administration of hOMSC200 or Placebo (control) all in addition to SOC treatment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Treatment related adverse events
  time frame: 6 months
  description: Occurrence of treatment-related adverse events assessed by common terminology criteria for adverse events (CTCAE) following recruitment, hOMSC200 administration (ID), and during the follow up.
  measure: Wound healing
  time frame: 24 weeks
  description: Percentage of wound surface area reduction
  arm group label: Low dose hOMSC200
  arm group type: Experimental
  description: Administration of low dose hOMSC200 in addition to routine standard of care
  arm group label: High dose hOMSC200
  arm group type: Experimental
  description: Administration of high dose hOMSC200 in addition to routine standard of care
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Administration of placebo in addition to routine standard of care
  intervention type: Biological
  intervention name: hOMSC200
  description: Human Oral Mucosal Stem Cells
  arm group label: High dose hOMSC200
  arm group label: Low dose hOMSC200
  intervention type: Other
  intervention name: Placebo
  description: Animal component-free, defined cryopreservation medium with 5% DMSO
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Israel
  responsible party type: Sponsor
  mesh term: Diabetic Foot
  mesh term: Foot Ulcer
  mesh term: Ulcer