<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/NCT03005249</url>
  </required_header>
  <id_info>
    <org_study_id>LCKY2016-60</org_study_id>
    <nct_id>NCT03005249</nct_id>
  </id_info>
  <brief_title>Neural Stem Cells Therapy for Cerebral Palsy</brief_title>
  <official_title>Neural Stem Cells Therapy for Cerebral Palsy: a Prospective, Randomized, Parallel-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital of Dalian Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital of Dalian Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the safety and efficacy of neural stem cells (NSCs) therapy for cerebral palsy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cerebral palsy is the most severe lifelong disability disease in childhood. In China, an&#xD;
      epidemiological investigation of cerebral palsy in 2004 has reported that 2.74‰ (about&#xD;
      6.50-9.75 million) of children suffered from cerebral palsy. The costs of medical expenses,&#xD;
      living allowance and nursing care can go up to RMB 20000-50000 yuan per year for each child&#xD;
      with cerebral palsy and thus China will expend RMB 120-300 billion yuan per year for children&#xD;
      with cerebral palsy. With full liberalization of two-child policy, there is an increasing&#xD;
      number of second babies born to women who are 35 years or older. Thus, the incidence of&#xD;
      cerebral palsy tends to increase. There is currently no cure for cerebral palsy, resulting in&#xD;
      a heavy burden for families and on society. Recent clinical trials performed in countries&#xD;
      outside China have demonstrated that stem cell therapy is likely the most effective method to&#xD;
      treat cerebral palsy. Fifteen trials regarding stem cell therapy for cerebral palsy have been&#xD;
      registered with ClinicalTrials.gov. In China, there have been no standardized registered&#xD;
      trials regarding stem cell therapy for cerebral palsy, which greatly restricts its clinical&#xD;
      application. In October 2016, the National Health and Family Planning Commission and the Food&#xD;
      and Drug Administration of China jointly announced the premier stem cell clinical research&#xD;
      institutions, making performing standardized trials regarding stem cell therapy for cerebral&#xD;
      palsy in China possible.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">September 2019</primary_completion_date>
  <phase>N/A</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>GMFM-88 score</measure>
    <time_frame>changes of month 1, month 3, month 6, month 9 and month 12 after therapy</time_frame>
    <description>To evaluate change in gross motor function in children with cerebral palsy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fine Motor Function Measure (FMFM) score</measure>
    <time_frame>changes of month 1, month 3, month 6, month 9 and month 12 after therapy</time_frame>
    <description>To evaluate change in fine motor function in children with cerebral palsy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Ashworth Scale score</measure>
    <time_frame>changes of month 1, month 3, month 6, month 9 and month 12 after therapy</time_frame>
    <description>To measure resistance during passive soft-tissue stretching and is used as a simple measure of spasticity.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>neural stem cells therapy group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients will be assigned to neural stem cells therapy group for cerebral palsy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>the control group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients will be assigned to the control group for cerebral palsy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>neural stem cells therapy group</intervention_name>
    <description>The patients will be assigned to neural stem cells therapy group for cerebral palsy.</description>
    <arm_group_label>neural stem cells therapy group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>the control group</intervention_name>
    <description>The patients will be assigned to the control group for cerebral palsy.</description>
    <arm_group_label>the control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Neonates with ischemic/hypoxic cerebral palsy (mainly including neonate with asphyxia&#xD;
             and premature infants);&#xD;
&#xD;
          -  Clinical manifestation of spastic tetraplegia;&#xD;
&#xD;
          -  With moderate to severe cerebral palsy, The Gross Motor Function; Classification&#xD;
             System (GMFCS) levels IV-V;&#xD;
&#xD;
          -  Age 1-5 years, of either sex;&#xD;
&#xD;
          -  Provision of signed informed consent by one of his/her parents or legal guardians&#xD;
             prior to commencement of this study;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Systemic diseases that possibly influence treatment or patient's compliance;&#xD;
&#xD;
          -  Potentially life-threatening diseases involving various organ systems;&#xD;
&#xD;
          -  Brain deformity;&#xD;
&#xD;
          -  Abnormal behaviors or mood disorder;&#xD;
&#xD;
          -  Allergies from blood products;&#xD;
&#xD;
          -  Suffering from infectious disease;&#xD;
&#xD;
          -  Subjected to craniocerebral operations prior to screening.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jing Liu, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital of Dalian Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jing Liu, Ph.D</last_name>
    <phone>86041184394568</phone>
    <email>liujing.dlrmc@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Dalian Medical University</name>
      <address>
        <city>Dalian</city>
        <state>Liaoning</state>
        <zip>116011</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jing Liu, Ph.D</last_name>
      <phone>86041184394568</phone>
      <email>liujing.dlrmc@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>December 26, 2016</study_first_submitted>
  <study_first_submitted_qc>December 26, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>August 27, 2018</last_update_submitted>
  <last_update_submitted_qc>August 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The First Affiliated Hospital of Dalian Medical University</investigator_affiliation>
    <investigator_full_name>Liu Jing</investigator_full_name>
    <investigator_title>Chief Physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Palsy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03005249
org study id: LCKY2016-60
nct id: NCT03005249
lead sponsor: 
has dmc: Yes
To evaluate the safety and efficacy of neural stem cells (NSCs) therapy for cerebral palsy.
Cerebral palsy is the most severe lifelong disability disease in childhood. In China, an
      epidemiological investigation of cerebral palsy in 2004 has reported that 2.74‰ (about
      6.50-9.75 million) of children suffered from cerebral palsy. The costs of medical expenses,
      living allowance and nursing care can go up to RMB 20000-50000 yuan per year for each child
      with cerebral palsy and thus China will expend RMB 120-300 billion yuan per year for children
      with cerebral palsy. With full liberalization of two-child policy, there is an increasing
      number of second babies born to women who are 35 years or older. Thus, the incidence of
      cerebral palsy tends to increase. There is currently no cure for cerebral palsy, resulting in
      a heavy burden for families and on society. Recent clinical trials performed in countries
      outside China have demonstrated that stem cell therapy is likely the most effective method to
      treat cerebral palsy. Fifteen trials regarding stem cell therapy for cerebral palsy have been
      registered with ClinicalTrials.gov. In China, there have been no standardized registered
      trials regarding stem cell therapy for cerebral palsy, which greatly restricts its clinical
      application. In October 2016, the National Health and Family Planning Commission and the Food
      and Drug Administration of China jointly announced the premier stem cell clinical research
      institutions, making performing standardized trials regarding stem cell therapy for cerebral
      palsy in China possible.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: GMFM-88 score
time frame: changes of month 1, month 3, month 6, month 9 and month 12 after therapy
description: To evaluate change in gross motor function in children with cerebral palsy.
measure: Fine Motor Function Measure (FMFM) score
time frame: changes of month 1, month 3, month 6, month 9 and month 12 after therapy
description: To evaluate change in fine motor function in children with cerebral palsy.
measure: Modified Ashworth Scale score
time frame: changes of month 1, month 3, month 6, month 9 and month 12 after therapy
description: To measure resistance during passive soft-tissue stretching and is used as a simple measure of spasticity.
arm group label: neural stem cells therapy group
arm group type: Experimental
description: The patients will be assigned to neural stem cells therapy group for cerebral palsy.
arm group label: the control group
arm group type: Experimental
description: The patients will be assigned to the control group for cerebral palsy.
intervention type: Procedure
intervention name: neural stem cells therapy group
description: The patients will be assigned to neural stem cells therapy group for cerebral palsy.
arm group label: neural stem cells therapy group
intervention type: Other
intervention name: the control group
description: The patients will be assigned to the control group for cerebral palsy.
arm group label: the control group
criteria: 
gender: All
minimum age: 1 Year
maximum age: 12 Years
healthy volunteers: No
last name: Jing Liu, Ph.D
role: Principal Investigator
affiliation: The First Affiliated Hospital of Dalian Medical University
last name: Jing Liu, Ph.D
phone: 86041184394568
email: liujing.dlrmc@hotmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The First Affiliated Hospital of Dalian Medical University
investigator full name: Liu Jing
investigator title: Chief Physician
mesh term: Cerebral Palsy
sharing ipd: Undecided