<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/NCT02236065</url>
  </required_header>
  <id_info>
    <org_study_id>UCBnG-CSF</org_study_id>
    <nct_id>NCT02236065</nct_id>
  </id_info>
  <brief_title>Combination Therapy of Cord Blood and G-CSF for Patients With Brain Injury or Neurodegenerative Disorders</brief_title>
  <official_title>A Pilot Study of Combination Therapy of Allogeneic Umbilical Cord Blood and Granulocyte-colony Stimulating Factor for Patients With Brain Injury or Neurodegenerative Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MinYoung Kim, M.D.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bundang CHA Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This open label trial is conducted to investigate the efficacy and safety of the combination&#xD;
      therapy of allogeneic umbilical cord blood (UCB) and granulocyte-colony stimulating factor&#xD;
      (G-CSF) for patients with brain injury or neurodegenerative disorders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Current treatments for brain injury or neurodegenerative disorders are palliative rather than&#xD;
      curative. Preclinical and some clinical studies suggest that UCB and G-CSF can be used as&#xD;
      restorative approach for such disorders.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</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>Changes in Berg Balance Scale</measure>
    <time_frame>Baseline - 1 month - 3 months - 6 months</time_frame>
    <description>Berg Balance Scale for brain injury and parkinson's disease (range: 0 to 56, Higher scores indicates better balance function.)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in the Level of Disability</measure>
    <time_frame>Baseline - 1 month - 3 months - 6 months</time_frame>
    <description>FIM (Functional Independence Measure) for brain injury and cerebral palsy (range: 18 to 126, Higher scores indicate more independence in activities of daily living.)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Standardized Gross Motor Function</measure>
    <time_frame>Baseline - 1 month - 3 months - 6 months</time_frame>
    <description>GMFM (Gross Motor Function Measure) for cerebral palsy (range: 0 to 100, Higher scores indicate better gross motor function.)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Motor Performance</measure>
    <time_frame>Baseline - 1 month - 3 months - 6 months</time_frame>
    <description>GMPM (Gross Motor Performance Measure) for cerebral palsy (range: 0 to 100, Higher scores indicate better motor quality.)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in ALSFRS-R</measure>
    <time_frame>Baseline - 1 month - 3 months - 6 months</time_frame>
    <description>ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-revised) for ALS (range: 0 to 48, Higher scores indicate better physical function.)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in UPDRS</measure>
    <time_frame>Baseline - 1 month - 3 months - 6 months</time_frame>
    <description>UPDRS (Unified Parkinson's Disease Rating Scale) for parkinson's disease (Part 1: mentation, behavior and mood; Part 2: activities of daily living; Part 3: motor examination; Part 4: complications of therapy; Part 5: Schwab and England activities of daily living scale)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Brain MRI</measure>
    <time_frame>Baseline - 6 months</time_frame>
    <description>Analysis of Diffusion Tensor Image (DTI) for brain injury, cerebral palsy, ALS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Brain PET</measure>
    <time_frame>Baseline - 6 months</time_frame>
    <description>for parkinson's disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events and participants with those adverse events</measure>
    <time_frame>6 months</time_frame>
    <description>The numbers of adverse events and subjects with those serious adverse events within each group; A serious adverse event is any untoward medical occurrence that at any dose: results in death or is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or causes a congenital anomaly/birth defect.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Brain Injury</condition>
  <condition>Cerebral Palsy</condition>
  <condition>Amyotrophic Lateral Sclerosis</condition>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>UCB + G-CSF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>UCB + G-CSF</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Umbilical cord blood therapy</intervention_name>
    <arm_group_label>UCB + G-CSF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Filgrastim</intervention_name>
    <arm_group_label>UCB + G-CSF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: should be included one of the 4 disorders&#xD;
&#xD;
          -  Brain injury: onset duration over 12 months, Age: 19 years or over&#xD;
&#xD;
          -  Cerebral palsy: spastic, dyskinetic or ataxic, Age: 19 years or over&#xD;
&#xD;
          -  Parkinson's disease: modified Hoehn and Yahr stage 2.5, 3, 4, Age: 30 to 75 years&#xD;
&#xD;
          -  ALS: definite of possible ALS, progression during the past 6 months, Age: 19 to 65&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled pulmonary, renal dysfunction at enrollment&#xD;
&#xD;
          -  Uncontrolled seizure&#xD;
&#xD;
          -  Malignant cancer&#xD;
&#xD;
          -  Possibility of hypersensitivity to drugs used in this study&#xD;
&#xD;
          -  Contraindication to the study intervention or assessment&#xD;
&#xD;
          -  Pregnant or breast feeding women&#xD;
&#xD;
          -  Non-compliance with the study visits specified in the protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHA Bundang Medical Center, CHA University</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggi-do</state>
        <zip>463-712</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>October 10, 2017</last_update_submitted>
  <last_update_submitted_qc>October 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Bundang CHA Hospital</investigator_affiliation>
    <investigator_full_name>MinYoung Kim, M.D.</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Umbilical cord blood</keyword>
  <keyword>Granulocyte-colony stimulating factor</keyword>
  <keyword>Brain injury</keyword>
  <keyword>Neurodegenerative disorder</keyword>
  <keyword>Efficacy</keyword>
  <keyword>Safety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Cerebral Palsy</mesh_term>
    <mesh_term>Motor Neuron Disease</mesh_term>
    <mesh_term>Amyotrophic Lateral Sclerosis</mesh_term>
    <mesh_term>Neurodegenerative Diseases</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lenograstim</mesh_term>
  </intervention_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/NCT02236065
org study id: UCBnG-CSF
nct id: NCT02236065
lead sponsor: 
has dmc: No
This open label trial is conducted to investigate the efficacy and safety of the combination
      therapy of allogeneic umbilical cord blood (UCB) and granulocyte-colony stimulating factor
      (G-CSF) for patients with brain injury or neurodegenerative disorders.
Current treatments for brain injury or neurodegenerative disorders are palliative rather than
      curative. Preclinical and some clinical studies suggest that UCB and G-CSF can be used as
      restorative approach for such disorders.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in Berg Balance Scale
time frame: Baseline - 1 month - 3 months - 6 months
description: Berg Balance Scale for brain injury and parkinson's disease (range: 0 to 56, Higher scores indicates better balance function.)
measure: Changes in the Level of Disability
time frame: Baseline - 1 month - 3 months - 6 months
description: FIM (Functional Independence Measure) for brain injury and cerebral palsy (range: 18 to 126, Higher scores indicate more independence in activities of daily living.)
measure: Changes in Standardized Gross Motor Function
time frame: Baseline - 1 month - 3 months - 6 months
description: GMFM (Gross Motor Function Measure) for cerebral palsy (range: 0 to 100, Higher scores indicate better gross motor function.)
measure: Changes in Motor Performance
time frame: Baseline - 1 month - 3 months - 6 months
description: GMPM (Gross Motor Performance Measure) for cerebral palsy (range: 0 to 100, Higher scores indicate better motor quality.)
measure: Changes in ALSFRS-R
time frame: Baseline - 1 month - 3 months - 6 months
description: ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-revised) for ALS (range: 0 to 48, Higher scores indicate better physical function.)
measure: Changes in UPDRS
time frame: Baseline - 1 month - 3 months - 6 months
description: UPDRS (Unified Parkinson's Disease Rating Scale) for parkinson's disease (Part 1: mentation, behavior and mood; Part 2: activities of daily living; Part 3: motor examination; Part 4: complications of therapy; Part 5: Schwab and England activities of daily living scale)
measure: Changes in Brain MRI
time frame: Baseline - 6 months
description: Analysis of Diffusion Tensor Image (DTI) for brain injury, cerebral palsy, ALS
measure: Changes in Brain PET
time frame: Baseline - 6 months
description: for parkinson's disease
measure: Number of adverse events and participants with those adverse events
time frame: 6 months
description: The numbers of adverse events and subjects with those serious adverse events within each group; A serious adverse event is any untoward medical occurrence that at any dose: results in death or is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or causes a congenital anomaly/birth defect.
arm group label: UCB + G-CSF
arm group type: Experimental
description: UCB + G-CSF
intervention type: Procedure
intervention name: Umbilical cord blood therapy
arm group label: UCB + G-CSF
intervention type: Biological
intervention name: Filgrastim
arm group label: UCB + G-CSF
criteria: 
gender: All
minimum age: 19 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor-Investigator
investigator affiliation: Bundang CHA Hospital
investigator full name: MinYoung Kim, M.D.
investigator title: Professor
mesh term: Parkinson Disease
mesh term: Brain Injuries
mesh term: Cerebral Palsy
mesh term: Motor Neuron Disease
mesh term: Amyotrophic Lateral Sclerosis
mesh term: Neurodegenerative Diseases
mesh term: Wounds and Injuries
mesh term: Lenograstim