<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/NCT02210624</url>
  </required_header>
  <id_info>
    <org_study_id>HYNR_CS_ABI001</org_study_id>
    <nct_id>NCT02210624</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Assessment of Autologous Bone-marrow Derived Adult Mesenchymal Stem Cell Therapy in Patients With Anoxic(or Hypoxic) Brain Injury Pilot Trial</brief_title>
  <official_title>An Open-label, Safety and Efficacy Assessment of Autologous Bone-marrow Derived Mesenchymal Stem Cell Therapy in Anoxic (or Hypoxic) Brain Injury.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hyun Young Kim</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hanyang University Seoul Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of study is to evaluate the safety and efficacy of autologous bone marrow-derived&#xD;
      stem cells therapy in patients with anaerobic (hypoxic) brain injury. Stem cell therapy is an&#xD;
      emerging alternative treatment modality in incurable and intractable neurological disorders.&#xD;
      This pilot study aims to evaluate the feasibility and safety of stem cells in anaerobic brain&#xD;
      injury.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Various treatment modalities to minimize the neurological deficits of anoxic brain injury,&#xD;
      including lower consciousness, abnormal movement disorders, and abnormal behavior, have been&#xD;
      tried, but so far there have been no effective proven method for chronic patients.&#xD;
&#xD;
      This study is the investigator initiated trial to verify the safety and feasibility of stem&#xD;
      cells therapy in patients with anoxic brain injury.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2013</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>N/A</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>safety assessment</measure>
    <time_frame>week 1, 3, 4, 5, 7</time_frame>
    <description>Each visit physical examination, neurological examination, and adverse reactions through the follow-up to the expression of new symptoms.&#xD;
week 1,3,5,7 conducted Hematological week 4,7 conducted MRI, PET</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glasgow Coma Scale(GCS)</measure>
    <time_frame>Week 1, 4, 5, 6, 7</time_frame>
    <description>assess level of consciousness after head injury</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FOUR score</measure>
    <time_frame>Week 1, 4, 5, 6, 7</time_frame>
    <description>The FOUR Score is a clinical grading scale designed for use by medical professionals in the assessment of patients with impaired level of consciousness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Independence Measure(FIM)</measure>
    <time_frame>Week 1, 4, 5, 6, 7</time_frame>
    <description>The Functional Independence Measure (FIM™) instrument is a basic indicator of patient disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability Rating Scale(DRS)</measure>
    <time_frame>Week 1, 4, 5, 6, 7</time_frame>
    <description>The Disability Rating Scale (DRS) is primarily used to assess impairment, disability, and handicap of an individual.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebral Performance Category(CPC)scale</measure>
    <time_frame>Week 1, 4, 5, 6, 7</time_frame>
    <description>The Cerebral Performance Category score is to use measure of functional outcome after cardiac arrest.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">4</enrollment>
  <condition>Anoxic Brain Injury</condition>
  <arm_group>
    <arm_group_label>Single arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental: HYNR-CS inj.&#xD;
Treatment group with HYNR-CS inj.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>HYNR-CS inj.</intervention_name>
    <description>Intrathecal injection with 1ml/10kg of body weight at an interval of 26 days.</description>
    <arm_group_label>Single arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 14 days after the index event occurs in an oxygen-free brain&#xD;
             injury patients&#xD;
&#xD;
          -  Severe disability or moderate due to anoxic brain injury&#xD;
&#xD;
          -  18 years to 75 years&#xD;
&#xD;
          -  Patients was 7 points less than Glasgow coma scale (GCS) After the resumption of blood&#xD;
             flow circulation.&#xD;
&#xD;
          -  anaerobic unexpected (hypoxic) cerebral ischemia Encephalopathy (It should not be a&#xD;
             hypoxic brain ischemia was induced due to heart surgery, which is scheduled)&#xD;
&#xD;
          -  Subjects agreed in writing that it will be participating in clinical research, as&#xD;
             viewed from the legal representative (patient)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who require ventilator continued&#xD;
&#xD;
          -  Patients who had extracorporeal membrane oxygenation(ECMO) index event occurs at the&#xD;
             time&#xD;
&#xD;
          -  Patients who had a history of cardiac arrest prior to the occurrence of Index event&#xD;
&#xD;
          -  End-stage people of less than 12 months is expected (incurable) disease patients&#xD;
&#xD;
          -  Patients with cardiac arrest occurred due to brain trauma severe&#xD;
&#xD;
          -  Patients with damage to other organs of severe&#xD;
&#xD;
          -  Patients with bleeding or malignant current&#xD;
&#xD;
          -  Pregnant patient&#xD;
&#xD;
          -  Patients with central nervous system tumors undergoing radiation therapy or&#xD;
             chemotherapy&#xD;
&#xD;
          -  If the patient or are participating in other clinical trials, you are planning to&#xD;
             participate, or patients three months after the end is not passed to participate in&#xD;
             other clinical trials&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hyun Young Kim, MD.,PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hanyang University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hyun Young Kim, MD,. PhD.</last_name>
    <phone>+82-2-2290-8373</phone>
    <email>hyoungkim1@hanyang.ac.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hanyang University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>133-792</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Hyun Young Kim, MD,. PhD.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <link>
    <url>https://seoul.hyumc.com/</url>
    <description>Hanyang University Medical Center</description>
  </link>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>August 8, 2017</last_update_submitted>
  <last_update_submitted_qc>August 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hanyang University Seoul Hospital</investigator_affiliation>
    <investigator_full_name>Hyun Young Kim</investigator_full_name>
    <investigator_title>seong joon kwon</investigator_title>
  </responsible_party>
  <keyword>Anoxic Brain Injury</keyword>
  <keyword>Autologous bone marrow derived stem cell</keyword>
  <keyword>stoke</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <!-- 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/NCT02210624
org study id: HYNR_CS_ABI001
nct id: NCT02210624
lead sponsor: 
has dmc: Yes
The purpose of study is to evaluate the safety and efficacy of autologous bone marrow-derived
      stem cells therapy in patients with anaerobic (hypoxic) brain injury. Stem cell therapy is an
      emerging alternative treatment modality in incurable and intractable neurological disorders.
      This pilot study aims to evaluate the feasibility and safety of stem cells in anaerobic brain
      injury.
Various treatment modalities to minimize the neurological deficits of anoxic brain injury,
      including lower consciousness, abnormal movement disorders, and abnormal behavior, have been
      tried, but so far there have been no effective proven method for chronic patients.

      This study is the investigator initiated trial to verify the safety and feasibility of stem
      cells therapy in patients with anoxic brain injury.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: safety assessment
time frame: week 1, 3, 4, 5, 7
description: Each visit physical examination, neurological examination, and adverse reactions through the follow-up to the expression of new symptoms.
week 1,3,5,7 conducted Hematological week 4,7 conducted MRI, PET
measure: Glasgow Coma Scale(GCS)
time frame: Week 1, 4, 5, 6, 7
description: assess level of consciousness after head injury
measure: FOUR score
time frame: Week 1, 4, 5, 6, 7
description: The FOUR Score is a clinical grading scale designed for use by medical professionals in the assessment of patients with impaired level of consciousness.
measure: Functional Independence Measure(FIM)
time frame: Week 1, 4, 5, 6, 7
description: The Functional Independence Measure (FIM™) instrument is a basic indicator of patient disability.
measure: Disability Rating Scale(DRS)
time frame: Week 1, 4, 5, 6, 7
description: The Disability Rating Scale (DRS) is primarily used to assess impairment, disability, and handicap of an individual.
measure: Cerebral Performance Category(CPC)scale
time frame: Week 1, 4, 5, 6, 7
description: The Cerebral Performance Category score is to use measure of functional outcome after cardiac arrest.
arm group label: Single arm
arm group type: Experimental
description: Experimental: HYNR-CS inj.
Treatment group with HYNR-CS inj.
intervention type: Biological
intervention name: HYNR-CS inj.
description: Intrathecal injection with 1ml/10kg of body weight at an interval of 26 days.
arm group label: Single arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Hyun Young Kim, MD.,PhD.
role: Principal Investigator
affiliation: Hanyang University
last name: Hyun Young Kim, MD,. PhD.
phone: +82-2-2290-8373
email: hyoungkim1@hanyang.ac.kr
facility: 
status: Recruiting
investigator: 
country: Korea, Republic of
url: https://seoul.hyumc.com/
description: Hanyang University Medical Center
responsible party type: Sponsor-Investigator
investigator affiliation: Hanyang University Seoul Hospital
investigator full name: Hyun Young Kim
investigator title: seong joon kwon
mesh term: Brain Injuries
mesh term: Wounds and Injuries