xml: <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/NCT05975424</url>
    </required_header>
    <id_info>
      <org_study_id>AST-OPC1-02</org_study_id>
      <nct_id>NCT05975424</nct_id>
    </id_info>
    <brief_title>LTFU Study of Subjects With Cervical SCI Who Received AST-OPC1</brief_title>
    <official_title>A Long-term Follow-up Study of Subjects With Cervical Spinal Cord Injuries Who Received AST-OPC1 in Protocol AST-OPC1-01</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Lineage Cell Therapeutics, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Lineage Cell Therapeutics, Inc.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a LTFU study for cervical SCI subjects that were administered AST-OPC1 cells in the&#xD;
        main study AST-OPC1-01.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Study AST-OPC1-02 is a Phase 1/2a open-label, multi-center long term follow-up (LTFU) study&#xD;
        for twenty-five (25) subjects with cervical SCI that were administered AST-OPC1 cells in the&#xD;
        main dose-escalation study AST-OPC1-01. The purpose of this study is to monitor long-term&#xD;
        safety in subjects for 15 years post AST-OPC1 administration.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">June 13, 2018</start_date>
    <completion_date type="Anticipated">January 14, 2033</completion_date>
    <primary_completion_date type="Anticipated">January 14, 2033</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>Incidence and severity of adverse events (AEs)</measure>
      <time_frame>Up to 15 years after AST-OPC1 injection</time_frame>
      <description>Information will be collected on all adverse events through Year 5 and on late-occurring adverse events (Years 6-15) related to any changes in neurological condition, a fever of unknown etiology, and the development of neoplasias and/or neurological disorders.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes from baseline greater than 1.5x or 2x in chemistry and hematology panel results over 5 years after injection of AST-OPC1</measure>
      <time_frame>Up to 5 years after AST-OPC1 injection</time_frame>
      <description>Summary statistics will be tabulated for chemistry and hematology laboratory parameter results and change from baseline to Year 5, as applicable, by cohort and overall. A table counting abnormal flags based on the respective lab's reference ranges by time point will be generated for each cohort and overall. At each visit, for each parameter, the number of subjects with low, normal, high, and clinically significant assessments will be tabulated.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes at the injection site as monitored by MRI</measure>
      <time_frame>Up to 5 years after AST-OPC1 injection</time_frame>
      <description>MRI scans will monitor the brain and cervical spine for any possible long-term changes that could be related to AST-OPC1</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes in neurologic function as assessed by the ISNCSCI</measure>
      <time_frame>Up to 5 years after AST-OPC1 injection</time_frame>
      <description>Subject baseline results will be compared against changes in motor and sensory examination results</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">25</enrollment>
    <condition>Spinal Cord Injuries</condition>
    <arm_group>
      <arm_group_label>Subjects treated with AST-OPC1 in the initial dosing study AST-OPC1-01</arm_group_label>
      <description>Subjects treated with AST-OPC1 in the initial dosing study AST-OPC1-01 will be followed for 15-year long-term safety monitoring</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Magnetic Resonance Imaging (MRI)</intervention_name>
      <description>Observational study; annual MRI for first 5 years only to monitor changes in the injection site</description>
      <arm_group_label>Subjects treated with AST-OPC1 in the initial dosing study AST-OPC1-01</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Blood samples for immune response monitoring and xenotransplantation safety samples.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Subjects who received administration of AST-OPC1 under clinical study protocol AST-OPC1-01&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subjects who received AST-OPC1 under Study AST-OPC1-01&#xD;
  &#xD;
            -  Reconfirmation of consent for long-term follow-up&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          •Subjects who, for geographic or compliance reasons, are inappropriate candidates for&#xD;
          participation in a long-term follow-up study in the opinion of the Investigator&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>69 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gary Hogge, DVM, MS, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Lineage Cell Therapeutics, Inc.</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>University of Southern California</name>
        <address>
          <city>Los Angeles</city>
          <state>California</state>
          <zip>90033</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Stanford University</name>
        <address>
          <city>Palo Alto</city>
          <state>California</state>
          <zip>94304</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Shepherd Center</name>
        <address>
          <city>Atlanta</city>
          <state>Georgia</state>
          <zip>30309</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>RUSH University Medical Center</name>
        <address>
          <city>Chicago</city>
          <state>Illinois</state>
          <zip>60612</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Thomas Jefferson University</name>
        <address>
          <city>Philadelphia</city>
          <state>Pennsylvania</state>
          <zip>19107</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Medical College of Wisconsin</name>
        <address>
          <city>Milwaukee</city>
          <state>Wisconsin</state>
          <zip>53226</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/35901693/</url>
      <description>A phase 1/2a dose-escalation study of oligodendrocyte progenitor cells in individuals with subacute cervical spinal cord injury</description>
    </link>
    <results_reference>
      <citation>Fessler RG, Ehsanian R, Liu CY, Steinberg GK, Jones L, Lebkowski JS, Wirth ED, McKenna SL. A phase 1/2a dose-escalation study of oligodendrocyte progenitor cells in individuals with subacute cervical spinal cord injury. J Neurosurg Spine. 2022 Jul 8;37(6):812-820. doi: 10.3171/2022.5.SPINE22167. Print 2022 Dec 1.</citation>
      <PMID>35901693</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</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>Spinal Cord Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05975424
  org study id: AST-OPC1-02
  nct id: NCT05975424
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  This is a LTFU study for cervical SCI subjects that were administered AST-OPC1 cells in the
        main study AST-OPC1-01.
  Study AST-OPC1-02 is a Phase 1/2a open-label, multi-center long term follow-up (LTFU) study
        for twenty-five (25) subjects with cervical SCI that were administered AST-OPC1 cells in the
        main dose-escalation study AST-OPC1-01. The purpose of this study is to monitor long-term
        safety in subjects for 15 years post AST-OPC1 administration.
  observational model: Cohort
  time perspective: Prospective
  measure: Incidence and severity of adverse events (AEs)
  time frame: Up to 15 years after AST-OPC1 injection
  description: Information will be collected on all adverse events through Year 5 and on late-occurring adverse events (Years 6-15) related to any changes in neurological condition, a fever of unknown etiology, and the development of neoplasias and/or neurological disorders.
  measure: Changes from baseline greater than 1.5x or 2x in chemistry and hematology panel results over 5 years after injection of AST-OPC1
  time frame: Up to 5 years after AST-OPC1 injection
  description: Summary statistics will be tabulated for chemistry and hematology laboratory parameter results and change from baseline to Year 5, as applicable, by cohort and overall. A table counting abnormal flags based on the respective lab's reference ranges by time point will be generated for each cohort and overall. At each visit, for each parameter, the number of subjects with low, normal, high, and clinically significant assessments will be tabulated.
  measure: Changes at the injection site as monitored by MRI
  time frame: Up to 5 years after AST-OPC1 injection
  description: MRI scans will monitor the brain and cervical spine for any possible long-term changes that could be related to AST-OPC1
  measure: Changes in neurologic function as assessed by the ISNCSCI
  time frame: Up to 5 years after AST-OPC1 injection
  description: Subject baseline results will be compared against changes in motor and sensory examination results
  arm group label: Subjects treated with AST-OPC1 in the initial dosing study AST-OPC1-01
  description: Subjects treated with AST-OPC1 in the initial dosing study AST-OPC1-01 will be followed for 15-year long-term safety monitoring
  intervention type: Diagnostic Test
  intervention name: Magnetic Resonance Imaging (MRI)
  description: Observational study; annual MRI for first 5 years only to monitor changes in the injection site
  arm group label: Subjects treated with AST-OPC1 in the initial dosing study AST-OPC1-01
  Blood samples for immune response monitoring and xenotransplantation safety samples.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 69 Years
  healthy volunteers: No
  last name: Gary Hogge, DVM, MS, PhD
  role: Study Chair
  affiliation: Lineage Cell Therapeutics, Inc.
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  country: United States
  url: https://pubmed.ncbi.nlm.nih.gov/35901693/
  description: A phase 1/2a dose-escalation study of oligodendrocyte progenitor cells in individuals with subacute cervical spinal cord injury
  citation: Fessler RG, Ehsanian R, Liu CY, Steinberg GK, Jones L, Lebkowski JS, Wirth ED, McKenna SL. A phase 1/2a dose-escalation study of oligodendrocyte progenitor cells in individuals with subacute cervical spinal cord injury. J Neurosurg Spine. 2022 Jul 8;37(6):812-820. doi: 10.3171/2022.5.SPINE22167. Print 2022 Dec 1.
  PMID: 35901693
  responsible party type: Sponsor
  mesh term: Spinal Cord Injuries
  sharing ipd: No