<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/NCT03815071</url>
  </required_header>
  <id_info>
    <org_study_id>NSC-PD-YNYY-01</org_study_id>
    <nct_id>NCT03815071</nct_id>
  </id_info>
  <brief_title>A Study on the Treatment of Parkinson's Disease With Autologous Neural Stem Cells</brief_title>
  <official_title>Clinical Study of the Safety and Efficacy of Autologous Neural Stem Cells in the Treatment of Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allife Medical Science and Technology Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The First People's Hospital of Yunnan Province/First People's Hospital of Yunan Provinve New Kunhua Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Henan Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Allife Medical Science and Technology Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</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, single arm and open-label study to investigate the safety and&#xD;
      efficacy of iPS-NCS with Parkinson's Disease&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 1, 2019</start_date>
  <completion_date type="Anticipated">February 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2020</primary_completion_date>
  <phase>Early Phase 1</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>occurrence of treatment related adverse events</measure>
    <time_frame>1 year</time_frame>
    <description>occurrence of treatment related adverse events that are possible, likely. Or definitely related to study treatment.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>ips-nsc treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ips-nsc cells</intervention_name>
    <description>Total dose of ips-nsc cells will be administered at day0.</description>
    <arm_group_label>ips-nsc treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The subject is able to understand the research requirements, provide written informed&#xD;
             consent, and complete the study in accordance with the procedures;&#xD;
&#xD;
          2. The subject is clearly diagnosed with Parkinson's;&#xD;
&#xD;
          3. Recorded disease progression over the past 6 months;&#xD;
&#xD;
          4. Vital organ function is satisfied: cardiac ultrasound indicates cardiac ejection&#xD;
             fraction ≥ 50%, no obvious abnormality in ECG; blood oxygen saturation ≥ 90%;&#xD;
             creatinine clearance calculated by Cockcroft-Gault formula ≥ 40ml/min; ALT and AST ≤ 3&#xD;
             times the normal range, total bilirubin ≤ 2.0 mg/dl;&#xD;
&#xD;
          5. Blood routine: Hgb≥80g/L, ANC≥1×109/L, PLT≥50×10/L;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Mental illness or a neurological disease not associated with Parkinson's disease;&#xD;
&#xD;
          2. Serious other concomitant diseases (tumor, organ failure, etc.);&#xD;
&#xD;
          3. Subjects used a large amount of corticosteroids, immunoglobulins, immunosuppressants&#xD;
             before entering the study;&#xD;
&#xD;
          4. Participated in other clinical trials of cell preparations and participated in other&#xD;
             clinical trials within 3 months;&#xD;
&#xD;
          5. There are already cognitive impairments or depressions, etc., and the research cannot&#xD;
             be completed well;&#xD;
&#xD;
          6. Female subjects who are breast-feeding or have a pregnancy plan recently.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</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>Parkinson Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03815071
org study id: NSC-PD-YNYY-01
nct id: NCT03815071
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a single center, single arm and open-label study to investigate the safety and
      efficacy of iPS-NCS with Parkinson's Disease
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: occurrence of treatment related adverse events
time frame: 1 year
description: occurrence of treatment related adverse events that are possible, likely. Or definitely related to study treatment.
arm group label: ips-nsc treatment group
arm group type: Experimental
intervention type: Drug
intervention name: Ips-nsc cells
description: Total dose of ips-nsc cells will be administered at day0.
arm group label: ips-nsc treatment group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Parkinson Disease
sharing ipd: No