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/NCT05993884</url>
    </required_header>
    <id_info>
      <org_study_id>CNYX-2020-003</org_study_id>
      <nct_id>NCT05993884</nct_id>
    </id_info>
    <brief_title>Safety and Preliminary Efficacy of Allogeneic Endothelial Progenitor Cells (EPCs) in Patients With Acute Ischemic Stroke</brief_title>
    <official_title>Phase I Clinical Study on the Safety and Preliminary Efficacy of Allogeneic Endothelial Progenitor Cells (EPCs) Injection in Patients With Acute Ischemic Stroke</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Allife Medical Science and Technology Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Allife Medical Science and Technology Co., Ltd.</source>
    <oversight_info>
      <has_dmc>Yes</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>
        This is a single center, randomized, double-blind, placebo-controlled, dose-Escalation&#xD;
        clinical study to investigate the safety and efficacy of EPCs transplantation in Acute&#xD;
        ischemic stroke.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Acute ischemic stroke (AIS) occurs when blood flow to the brain is blocked by a clot or&#xD;
        mechanical event and is the most common type of stroke. However, due to the limitation of&#xD;
        time and contraindications, only a few patients with AIS are eligible candidates. Endothelial&#xD;
        progenitor cells (EPCs) have the potential to reduce brain damage from AIS. They can&#xD;
        effectively repair endothelial cells with vascular injuries by directly differentiating into&#xD;
        endothelial cells or releasing corresponding regulatory factors, which is a potentially&#xD;
        important means for the prevention and treatment of a series of vascular system disorders.&#xD;
        The introduction of induced pluripotent stem cells (iPSCs) technology provides a highly&#xD;
        feasible option for clinical application of EPCs. Allogeneic iPSC-EPCs can be produced on a&#xD;
        large scale to provide enough cells, fundamentally solving the problem of insufficient&#xD;
        dosage, and making them a feasible clinical option for treatment of AIS.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">August 15, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 15, 2024</primary_completion_date>
    <phase>Phase 1</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>Evaluate the Incidence and severity of adverse events after iEPCs infusion</measure>
      <time_frame>baseline to 1 year</time_frame>
      <description>Incidence and severity of adverse events assessed by CTCAE V5.0 during the twelve-month study period after iEPCs infusion.</description>
    </primary_outcome>
    <other_outcome>
      <measure>HLA matching</measure>
      <time_frame>1 year</time_frame>
      <description>the level of HLA matching pairs of donor/recipient</description>
    </other_outcome>
    <other_outcome>
      <measure>plasma HLA antibody</measure>
      <time_frame>month 1, month 3, month 6, month 9, month 12</time_frame>
      <description>The change from the baseline of plasma HLA antibody will be calculated at month 1, month 3, month 6, month 9, month 12 post infusion, as available.</description>
    </other_outcome>
    <other_outcome>
      <measure>plasma T lymphocytes</measure>
      <time_frame>month 1, month 3, month 6, month 9, month 12</time_frame>
      <description>The change from the baseline in plasma T lymphocytes will be calculated at month 1, month 3, month 6, month 9, month 12 post infusion, as available.</description>
    </other_outcome>
    <other_outcome>
      <measure>plasma iEPCs</measure>
      <time_frame>month 1, month 3</time_frame>
      <description>The change from the baseline in plasma iEPCs will be calculated at month 1, month 3 post infusion, as available.</description>
    </other_outcome>
    <other_outcome>
      <measure>Modified Rankin Scale, mRS</measure>
      <time_frame>month 1, month 3, month 6</time_frame>
      <description>The change from the baseline in mRS will be calculated at month 1, month 3, month 6, as available. The scale is divided into 7 degrees, from 0 (no deficit) to 6 (dead).</description>
    </other_outcome>
    <other_outcome>
      <measure>National Institute of Health stroke scale, NIHSS</measure>
      <time_frame>month 1, month 3, month 6</time_frame>
      <description>The change from the baseline in NIHSS will be calculated at month 1, month 3, month 6 post-treatment, as available. The range of scores is from 0 (normal) to 42.</description>
    </other_outcome>
    <other_outcome>
      <measure>activity of daily living, ADL</measure>
      <time_frame>month 1, month 3, month 6</time_frame>
      <description>The change from the baseline in ADL will be calculated at month 1, month 3, month 6 post-treatment, as available. Every activity will be scored 5 and the range of scores is from 0 (normal) to 5.</description>
    </other_outcome>
    <other_outcome>
      <measure>cerebral infarct volume</measure>
      <time_frame>month 1, month 3, month 6</time_frame>
      <description>The change from baseline in cerebral infarct volume using MRI will be calculated at month 1, month 3, month 6 post-treatment, as available.</description>
    </other_outcome>
    <other_outcome>
      <measure>vascular endothelial growth factor, VEGF</measure>
      <time_frame>month 1, month 3, month 6, month 9, month 12</time_frame>
      <description>Changes of concentration of vascular endothelial growth factor（VEGF）in the serum from the baseline will be calculated at month 1, month 3, month 6, month 9, month 12 post-treatment, as available.</description>
    </other_outcome>
    <other_outcome>
      <measure>brain derived neurotrophic factor，BDNF</measure>
      <time_frame>month 1, month 3, month 6, month 9, month 12</time_frame>
      <description>Changes of concentration of brain derived neurotrophic factor (BDNF) in the serum from the baseline will be calculated at month 1, month 3, month 6, month 9, month 12 post-treatment, as available.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">27</enrollment>
    <condition>Acute Ischemic Stroke</condition>
    <arm_group>
      <arm_group_label>Treatment (clinical standard treatment, iEPCs)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients receive clinical standard treatment and iEPCs IV with a single dose</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo (clinical standard treatment, Placebo)</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Patients receive clinical standard treatment and placebo IV 150 mL with a single dose</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>iEPCs</intervention_name>
      <description>Given: IV</description>
      <arm_group_label>Treatment (clinical standard treatment, iEPCs)</arm_group_label>
      <other_name>iPSC EPCs</other_name>
    </intervention>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>Clinical standard treatment (CST)</intervention_name>
      <description>Clinical standard treatment</description>
      <arm_group_label>Placebo (clinical standard treatment, Placebo)</arm_group_label>
      <arm_group_label>Treatment (clinical standard treatment, iEPCs)</arm_group_label>
      <other_name>CST</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1. Able to provide consent to study or consent is obtained from the patient's legal&#xD;
               representative&#xD;
  &#xD;
            -  2. Male or females, aged 18 to 80 years&#xD;
  &#xD;
            -  3. Subjects with MRI confirmed AIS before start of treatment&#xD;
  &#xD;
            -  4. Subjects with NIHSS score between ≥ 6 points and ≤ 24 points at the time of&#xD;
               screening&#xD;
  &#xD;
            -  5. Eligible patients of childbearing potential (both men and women) if sexually active&#xD;
               must agree to use a reliable method of contraception with their partners&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1.Subject with disturbance of consciousness&#xD;
  &#xD;
            -  2.Subject with ischemic stroke progression or fluctuation&#xD;
  &#xD;
            -  3.Subjects with previous history of cerebrovascular diseases&#xD;
  &#xD;
            -  4.Subject with major organs dysfunction&#xD;
  &#xD;
            -  5.Subjects with history of malignancy&#xD;
  &#xD;
            -  6.Subjects with Pregnant or lactating subjects&#xD;
  &#xD;
            -  7.Subjects with known allergy to more than 2 drugs&#xD;
  &#xD;
            -  8.Current or recent history of alcohol or drug abuse&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Xingquan Zhao, Dr</last_name>
      <phone>01059978555</phone>
      <email>ttyyirb@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Qian Zhang, Dr</last_name>
      <phone>01059978555</phone>
      <email>ttyyirb@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Allife</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Hui Shi</last_name>
        <phone>18612648904</phone>
        <email>shihui@allifetech.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>April 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Acute Ischemic Stroke</keyword>
    <keyword>EPCs</keyword>
    <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/NCT05993884
  org study id: CNYX-2020-003
  nct id: NCT05993884
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This is a single center, randomized, double-blind, placebo-controlled, dose-Escalation
        clinical study to investigate the safety and efficacy of EPCs transplantation in Acute
        ischemic stroke.
  Acute ischemic stroke (AIS) occurs when blood flow to the brain is blocked by a clot or
        mechanical event and is the most common type of stroke. However, due to the limitation of
        time and contraindications, only a few patients with AIS are eligible candidates. Endothelial
        progenitor cells (EPCs) have the potential to reduce brain damage from AIS. They can
        effectively repair endothelial cells with vascular injuries by directly differentiating into
        endothelial cells or releasing corresponding regulatory factors, which is a potentially
        important means for the prevention and treatment of a series of vascular system disorders.
        The introduction of induced pluripotent stem cells (iPSCs) technology provides a highly
        feasible option for clinical application of EPCs. Allogeneic iPSC-EPCs can be produced on a
        large scale to provide enough cells, fundamentally solving the problem of insufficient
        dosage, and making them a feasible clinical option for treatment of AIS.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Evaluate the Incidence and severity of adverse events after iEPCs infusion
  time frame: baseline to 1 year
  description: Incidence and severity of adverse events assessed by CTCAE V5.0 during the twelve-month study period after iEPCs infusion.
  measure: HLA matching
  time frame: 1 year
  description: the level of HLA matching pairs of donor/recipient
  measure: plasma HLA antibody
  time frame: month 1, month 3, month 6, month 9, month 12
  description: The change from the baseline of plasma HLA antibody will be calculated at month 1, month 3, month 6, month 9, month 12 post infusion, as available.
  measure: plasma T lymphocytes
  time frame: month 1, month 3, month 6, month 9, month 12
  description: The change from the baseline in plasma T lymphocytes will be calculated at month 1, month 3, month 6, month 9, month 12 post infusion, as available.
  measure: plasma iEPCs
  time frame: month 1, month 3
  description: The change from the baseline in plasma iEPCs will be calculated at month 1, month 3 post infusion, as available.
  measure: Modified Rankin Scale, mRS
  time frame: month 1, month 3, month 6
  description: The change from the baseline in mRS will be calculated at month 1, month 3, month 6, as available. The scale is divided into 7 degrees, from 0 (no deficit) to 6 (dead).
  measure: National Institute of Health stroke scale, NIHSS
  time frame: month 1, month 3, month 6
  description: The change from the baseline in NIHSS will be calculated at month 1, month 3, month 6 post-treatment, as available. The range of scores is from 0 (normal) to 42.
  measure: activity of daily living, ADL
  time frame: month 1, month 3, month 6
  description: The change from the baseline in ADL will be calculated at month 1, month 3, month 6 post-treatment, as available. Every activity will be scored 5 and the range of scores is from 0 (normal) to 5.
  measure: cerebral infarct volume
  time frame: month 1, month 3, month 6
  description: The change from baseline in cerebral infarct volume using MRI will be calculated at month 1, month 3, month 6 post-treatment, as available.
  measure: vascular endothelial growth factor, VEGF
  time frame: month 1, month 3, month 6, month 9, month 12
  description: Changes of concentration of vascular endothelial growth factor（VEGF）in the serum from the baseline will be calculated at month 1, month 3, month 6, month 9, month 12 post-treatment, as available.
  measure: brain derived neurotrophic factor，BDNF
  time frame: month 1, month 3, month 6, month 9, month 12
  description: Changes of concentration of brain derived neurotrophic factor (BDNF) in the serum from the baseline will be calculated at month 1, month 3, month 6, month 9, month 12 post-treatment, as available.
  arm group label: Treatment (clinical standard treatment, iEPCs)
  arm group type: Experimental
  description: Patients receive clinical standard treatment and iEPCs IV with a single dose
  arm group label: Placebo (clinical standard treatment, Placebo)
  arm group type: Placebo Comparator
  description: Patients receive clinical standard treatment and placebo IV 150 mL with a single dose
  intervention type: Drug
  intervention name: iEPCs
  description: Given: IV
  arm group label: Treatment (clinical standard treatment, iEPCs)
  other name: iPSC EPCs
  intervention type: Combination Product
  intervention name: Clinical standard treatment (CST)
  description: Clinical standard treatment
  arm group label: Placebo (clinical standard treatment, Placebo)
  arm group label: Treatment (clinical standard treatment, iEPCs)
  other name: CST
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Xingquan Zhao, Dr
  phone: 01059978555
  email: ttyyirb@163.com
  last name: Qian Zhang, Dr
  phone: 01059978555
  email: ttyyirb@163.com
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Stroke
  mesh term: Ischemic Stroke
  mesh term: Cerebral Infarction
  mesh term: Ischemia