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/NCT06040476</url>
    </required_header>
    <id_info>
      <org_study_id>SCAS001</org_study_id>
      <nct_id>NCT06040476</nct_id>
    </id_info>
    <brief_title>Human Umbilical Cord Blood Infusion in Patients With Acute Ischemic Stroke (AIS)</brief_title>
    <official_title>A Phase II, Randomized, Double-blind, Parallel, Placebo-controlled Study to Assess the Safety and Efficacy of Human Umbilical Cord Blood Infusion in Patients With Acute Ischemic Stroke</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>StemCyte Taiwan Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>StemCyte International, Ltd.</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        A Phase II, Randomized, Double-blind, Parallel, Placebo-controlled Study to Assess the Safety&#xD;
        and Efficacy of Human Umbilical Cord Blood Infusion in Patients with Acute Ischemic Stroke&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a phase II study to evaluate the safety and efficacy in hUCB treatment on the&#xD;
        patients with acute ischemic stroke (AIS).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 2024</start_date>
    <completion_date type="Anticipated">August 2027</completion_date>
    <primary_completion_date type="Anticipated">January 2026</primary_completion_date>
    <phase>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>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>safety-TEAE</measure>
      <time_frame>From screening to 48 weeks</time_frame>
      <description>Frequency and incidence of treatment-emergent adverse events (TEAEs).</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">39</enrollment>
    <condition>Acute Ischemic Stroke</condition>
    <arm_group>
      <arm_group_label>A group: hUCB treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Human cord blood infusion</description>
    </arm_group>
    <arm_group>
      <arm_group_label>B group: Placebo treatment</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Placebo infusion</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>hUCB</intervention_name>
      <description>hUCB</description>
      <arm_group_label>A group: hUCB treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female subject ≥18 and ≤80 years of age.&#xD;
  &#xD;
            -  Subject with a confirmed diagnosis of AIS and hemiplegia&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subject with known immune disease, immunodeficiency, or receives immunosuppressive&#xD;
               therapy/immunomodulators within 4 weeks or 5 half-lives prior to screening, whichever&#xD;
               is longer.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 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>Stroke</mesh_term>
      <mesh_term>Ischemic Stroke</mesh_term>
      <mesh_term>Cerebral Infarction</mesh_term>
      <mesh_term>Ischemia</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/NCT06040476
  org study id: SCAS001
  nct id: NCT06040476
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  A Phase II, Randomized, Double-blind, Parallel, Placebo-controlled Study to Assess the Safety
        and Efficacy of Human Umbilical Cord Blood Infusion in Patients with Acute Ischemic Stroke
  This is a phase II study to evaluate the safety and efficacy in hUCB treatment on the
        patients with acute ischemic stroke (AIS).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: safety-TEAE
  time frame: From screening to 48 weeks
  description: Frequency and incidence of treatment-emergent adverse events (TEAEs).
  arm group label: A group: hUCB treatment
  arm group type: Experimental
  description: Human cord blood infusion
  arm group label: B group: Placebo treatment
  arm group type: No Intervention
  description: Placebo infusion
  intervention type: Biological
  intervention name: hUCB
  description: hUCB
  arm group label: A group: hUCB treatment
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Stroke
  mesh term: Ischemic Stroke
  mesh term: Cerebral Infarction
  mesh term: Ischemia