<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/NCT01725880</url>
  </required_header>
  <id_info>
    <org_study_id>CL-N03-SC</org_study_id>
    <secondary_id>TpP_I_2012_002</secondary_id>
    <nct_id>NCT01725880</nct_id>
  </id_info>
  <brief_title>Long-Term Follow-Up of Transplanted Human Central Nervous System Stem Cells (HuCNS-SC) in Spinal Cord Trauma Subjects</brief_title>
  <official_title>Long-term Follow-up (LTFU) Study of the Phase I/II Safety and Preliminary Efficacy Investigation of Intramedullary Spinal Cord Transplantation of HuCNS-SC® in Subjects With Thoracic (T2-T11) Spinal Cord Trauma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>StemCells, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>StemCells, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the long term safety and preliminary efficacy of&#xD;
      intramedullary transplantation of HuCNS-SC cells in subjects with thoracic spinal cord&#xD;
      trauma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigation is a multi-year observational study following the completion of the&#xD;
      open-label, single dose Phase I/II study involving transplantation of allogeneic HuCNS-SC&#xD;
      cells into 12 subjects with thoracic spinal cord injury.&#xD;
&#xD;
      Subjects will be monitored at routine intervals for safety and preliminary efficacy for four&#xD;
      years. The LTFU study will commence following the one year post-transplantation termination&#xD;
      visit of the Phase I/II investigation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Based on a business decision unrelated to any safety concerns.&#xD;
  </why_stopped>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>American Spinal Injury Association (ASIA) Impairment Scale Improvement</measure>
    <time_frame>Four years</time_frame>
    <description>Evidence of improvement in ASIA impairment scale as confirmed by neurological examination</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">12</enrollment>
  <condition>Spinal Cord Injury</condition>
  <arm_group>
    <arm_group_label>No treatment</arm_group_label>
    <description>Observation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observation</intervention_name>
    <arm_group_label>No treatment</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects who had undergone intramedullary transplantation of HuCNS-SC cells in the thoracic&#xD;
        region.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must have undergone HuCNS-SC transplantation as a subject in the Phase I/II trial&#xD;
&#xD;
          -  Must agree to comply in good faith with all conditions of the study and to attend all&#xD;
             required study visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects have received or are receiving off-protocol immunosuppressive medications&#xD;
&#xD;
          -  Subjects who, after completion of Phase I/II trial (Protocol # CL-N02-SC), have&#xD;
             entered or are about to enter any other investigational study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephen Huhn, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>StemCells, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uniklinik Balgrist</name>
      <address>
        <city>Zurich</city>
        <zip>8008</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>November 9, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>June 1, 2016</last_update_submitted>
  <last_update_submitted_qc>June 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 3, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Spinal Cord Injury</keyword>
  <keyword>HuCNS-SC cells</keyword>
  <keyword>Human Neural Stem Cells</keyword>
  <keyword>Neural Stem Cells</keyword>
  <keyword>Stem Cells</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord 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/NCT01725880
org study id: CL-N03-SC
secondary id: TpP_I_2012_002
nct id: NCT01725880
lead sponsor: 
has dmc: No
The purpose of this study is to determine the long term safety and preliminary efficacy of
      intramedullary transplantation of HuCNS-SC cells in subjects with thoracic spinal cord
      trauma.
The investigation is a multi-year observational study following the completion of the
      open-label, single dose Phase I/II study involving transplantation of allogeneic HuCNS-SC
      cells into 12 subjects with thoracic spinal cord injury.

      Subjects will be monitored at routine intervals for safety and preliminary efficacy for four
      years. The LTFU study will commence following the one year post-transplantation termination
      visit of the Phase I/II investigation.
observational model: Cohort
time perspective: Prospective
measure: American Spinal Injury Association (ASIA) Impairment Scale Improvement
time frame: Four years
description: Evidence of improvement in ASIA impairment scale as confirmed by neurological examination
arm group label: No treatment
description: Observation
intervention type: Other
intervention name: Observation
arm group label: No treatment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Stephen Huhn, M.D.
role: Study Director
affiliation: StemCells, Inc.
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Spinal Cord Injuries