<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/NCT03003364</url>
  </required_header>
  <id_info>
    <org_study_id>XCEL-SCI-01</org_study_id>
    <nct_id>NCT03003364</nct_id>
  </id_info>
  <brief_title>Intrathecal Administration of Expanded Wharton's Jelly Mesenchymal Stem Cells in Chronic Traumatic Spinal Cord Injury</brief_title>
  <official_title>A Phase I/IIa, Randomized, Double-blind, Single-dose, Placebo Controlled, Two-way Crossover Clinical Trial to Assess the Safety and to Obtain Efficacy Data in Intrathecal Administration of Expanded Wharton's Jelly Mesenchymal Stem Cells in Chronic Traumatic Spinal Cord Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Banc de Sang i Teixits</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital de Neurorehabilitació Institut Guttmann</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Recerca Clínica S.L.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Syntax for Science, S.L</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Banc de Sang i Teixits</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase I/IIa, randomized, double-blind, two-arms, two-dose administration, placebo&#xD;
      controlled, two-way crossover clinical trial in which 10 patients from 18 to 65 years of age&#xD;
      affected with chronic traumatic spinal cord will enter the study with the objective to assess&#xD;
      the safety and to obtain efficacy data in intrathecal administration of expanded Wharton's&#xD;
      jelly mesenchymal stem cells.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a phase I/IIa, randomized, double-blind, two-arms, two-dose administration, placebo&#xD;
      controlled, clinical trial in which 10 patients from 18 to 65 years of age affected with&#xD;
      chronic traumatic spinal cord will enter the study with the objective to assess the safety&#xD;
      and to obtain efficacy data in intrathecal administration (L3 level) of expanded Wharton's&#xD;
      jelly mesenchymal stem cells. Following the administration patients will remain for 24 h at&#xD;
      the hospital and thereafter will be discharged. For the first period, the follow-up is&#xD;
      planned at day 7 and at 1, 3 and 6 months. At month 6, the patients will be treated in a&#xD;
      crossover way (second period) and will follow the same schedule for the follow-up. First&#xD;
      clinical trial evaluation will be performed at 12 month follow-up. From 12 to 18 month after&#xD;
      the first infusion, patients will be randomized again to active treatment or placebo&#xD;
      (double-blind) in order to assess the safety and efficacy of a second dose at 12 month&#xD;
      follow-up. Thereafter, patients will be followed up at 24 and 36 months as part of a&#xD;
      long-term follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 27, 2016</start_date>
  <completion_date type="Actual">February 11, 2020</completion_date>
  <primary_completion_date type="Actual">July 25, 2019</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of treatment-emergent adverse events</measure>
    <time_frame>12 months</time_frame>
    <description>Adverse events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Extent and severity of a patient's spinal cord injury</measure>
    <time_frame>6 months</time_frame>
    <description>ASIA Impairment Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor electrophysiology assessment</measure>
    <time_frame>6 month</time_frame>
    <description>Evoked potentials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Somatosensory electrophysiology assessment</measure>
    <time_frame>6 month</time_frame>
    <description>Evoked potentials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electrical nerve stimulation on pain perception</measure>
    <time_frame>6 month</time_frame>
    <description>Pain threshold perception</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mictional dysfunction</measure>
    <time_frame>6 month</time_frame>
    <description>Urodynamic testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anal sphincter integrity</measure>
    <time_frame>6 month</time_frame>
    <description>Anorectal manometry test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropathic pain</measure>
    <time_frame>6 months</time_frame>
    <description>Numerical scale (0 to 10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spasticity</measure>
    <time_frame>6 months</time_frame>
    <description>Modified Ashworth scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functionality</measure>
    <time_frame>6 months</time_frame>
    <description>SCIM III scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (individual overall perception of quality of life, individual overall perception of their health, Physical health, Psychological, Social relationships, Environment)</measure>
    <time_frame>6 months</time_frame>
    <description>WHOQOL BREF questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary disorder</measure>
    <time_frame>6 months</time_frame>
    <description>Qualiveen questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Size injury</measure>
    <time_frame>12 months</time_frame>
    <description>Magnetic Resonance Imaging</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of allogeneic cells</measure>
    <time_frame>1 month</time_frame>
    <description>Chimerism in cerebrospinal fluid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunology</measure>
    <time_frame>1 months</time_frame>
    <description>Antibodies anti-HLA in peripherical blood and in cerebrospinal fluid</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Spinal Cord Injury, Chronic</condition>
  <arm_group>
    <arm_group_label>XCEL-UMC-BETA/placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ex vivo cultured human mesenchymal stem cells from Wharton jelly, in a blinded syringe (initial treatment) / Placebo (month 6)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo/XCEL-UMC-BETA</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo in a blinded syringe (initial treatment) / XCEL-UMC-BETA (month 6)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>XCEL-UMC-BETA</intervention_name>
    <description>Intrathecal allogeneic cell therapy in a blinded syringe</description>
    <arm_group_label>Placebo/XCEL-UMC-BETA</arm_group_label>
    <arm_group_label>XCEL-UMC-BETA/placebo</arm_group_label>
    <other_name>Expanded MSC from Wharton Jelly</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo in a blinded syringe</description>
    <arm_group_label>Placebo/XCEL-UMC-BETA</arm_group_label>
    <arm_group_label>XCEL-UMC-BETA/placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Single spinal cord injury lesion caused by trauma&#xD;
&#xD;
          2. Affected cord segments between T2 and T11, confirmed by magnetic resonance&#xD;
&#xD;
          3. Complete paraplegia (ASIA A)&#xD;
&#xD;
          4. Chronic disease state (between 12 months and 5 years after the injury)&#xD;
&#xD;
          5. Patients from 18 to 65 years of age, both sexes&#xD;
&#xD;
          6. Life expectancy &gt; 2 years&#xD;
&#xD;
          7. Confidence that the patient will attend the follow-up visits.&#xD;
&#xD;
          8. Given informed consent in writing&#xD;
&#xD;
          9. Patient is able to understand the study and its procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Mechanic ventilation&#xD;
&#xD;
          2. Lesion affecting multiple levels&#xD;
&#xD;
          3. Lesion length superior to 3 spinal cord segments, assessed by magnetic resonance&#xD;
&#xD;
          4. Penetrating trauma affecting the spinal cord&#xD;
&#xD;
          5. Positive serology to HIV, HBV, HCV and or syphilis&#xD;
&#xD;
          6. Pregnant woman or without proper anticonceptive measures according to the&#xD;
             investigator, or breath feeding&#xD;
&#xD;
          7. Use of metal implants that complicates the MRI interpretation&#xD;
&#xD;
          8. Planned spinal surgery within subsequent 24 month after entering the trial&#xD;
&#xD;
          9. Intrathecal medication or immunosuppressive drugs the previous 60 days.&#xD;
&#xD;
         10. Neurodegenerative diseases&#xD;
&#xD;
         11. Significant abnormal laboratory tests that contraindicates patient's participation in&#xD;
             the study.&#xD;
&#xD;
         12. Neoplasia within the previous 5 years, or without complete remission&#xD;
&#xD;
         13. Patient with difficulty for communicating&#xD;
&#xD;
         14. Participation in another clinical trial or treated with an investigational medicinal&#xD;
             product the previous 60 days&#xD;
&#xD;
         15. Contraindication for lumbar punction&#xD;
&#xD;
         16. Other pathologic conditions or circumstances that could complicate the participation&#xD;
             of the patient in the study according to medical criteria&#xD;
&#xD;
         17. The patient does not accept to be followed-up for a period that could exceed the&#xD;
             clinical trial length&#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>Joan Vidal, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital de Neurorehabilitació Institut Guttmann</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital de Neurorehabilitació Institut Guttmann</name>
      <address>
        <city>Badalona</city>
        <state>Barcelona</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://bancsang.net/en_index/</url>
    <description>Blood and Tissue Bank of Catalonia</description>
  </link>
  <link>
    <url>http://www.guttmann.com/en</url>
    <description>Hospital de Neurorehabilitació Institut Guttmann</description>
  </link>
  <link>
    <url>http://www.ccma.cat/tv3/marato/en/</url>
    <description>Marató TV3</description>
  </link>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>February 13, 2020</last_update_submitted>
  <last_update_submitted_qc>February 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2020</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>
    <mesh_term>Wounds and 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>


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/NCT03003364
org study id: XCEL-SCI-01
nct id: NCT03003364
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This is a phase I/IIa, randomized, double-blind, two-arms, two-dose administration, placebo
      controlled, two-way crossover clinical trial in which 10 patients from 18 to 65 years of age
      affected with chronic traumatic spinal cord will enter the study with the objective to assess
      the safety and to obtain efficacy data in intrathecal administration of expanded Wharton's
      jelly mesenchymal stem cells.
This is a phase I/IIa, randomized, double-blind, two-arms, two-dose administration, placebo
      controlled, clinical trial in which 10 patients from 18 to 65 years of age affected with
      chronic traumatic spinal cord will enter the study with the objective to assess the safety
      and to obtain efficacy data in intrathecal administration (L3 level) of expanded Wharton's
      jelly mesenchymal stem cells. Following the administration patients will remain for 24 h at
      the hospital and thereafter will be discharged. For the first period, the follow-up is
      planned at day 7 and at 1, 3 and 6 months. At month 6, the patients will be treated in a
      crossover way (second period) and will follow the same schedule for the follow-up. First
      clinical trial evaluation will be performed at 12 month follow-up. From 12 to 18 month after
      the first infusion, patients will be randomized again to active treatment or placebo
      (double-blind) in order to assess the safety and efficacy of a second dose at 12 month
      follow-up. Thereafter, patients will be followed up at 24 and 36 months as part of a
      long-term follow-up.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Incidence of treatment-emergent adverse events
time frame: 12 months
description: Adverse events
measure: Extent and severity of a patient's spinal cord injury
time frame: 6 months
description: ASIA Impairment Scale
measure: Motor electrophysiology assessment
time frame: 6 month
description: Evoked potentials
measure: Somatosensory electrophysiology assessment
time frame: 6 month
description: Evoked potentials
measure: Electrical nerve stimulation on pain perception
time frame: 6 month
description: Pain threshold perception
measure: Mictional dysfunction
time frame: 6 month
description: Urodynamic testing
measure: Anal sphincter integrity
time frame: 6 month
description: Anorectal manometry test
measure: Neuropathic pain
time frame: 6 months
description: Numerical scale (0 to 10)
measure: Spasticity
time frame: 6 months
description: Modified Ashworth scale
measure: Functionality
time frame: 6 months
description: SCIM III scale
measure: Quality of life (individual overall perception of quality of life, individual overall perception of their health, Physical health, Psychological, Social relationships, Environment)
time frame: 6 months
description: WHOQOL BREF questionnaire
measure: Urinary disorder
time frame: 6 months
description: Qualiveen questionnaire
measure: Size injury
time frame: 12 months
description: Magnetic Resonance Imaging
measure: Presence of allogeneic cells
time frame: 1 month
description: Chimerism in cerebrospinal fluid
measure: Immunology
time frame: 1 months
description: Antibodies anti-HLA in peripherical blood and in cerebrospinal fluid
arm group label: XCEL-UMC-BETA/placebo
arm group type: Experimental
description: Ex vivo cultured human mesenchymal stem cells from Wharton jelly, in a blinded syringe (initial treatment) / Placebo (month 6)
arm group label: Placebo/XCEL-UMC-BETA
arm group type: Placebo Comparator
description: Placebo in a blinded syringe (initial treatment) / XCEL-UMC-BETA (month 6)
intervention type: Drug
intervention name: XCEL-UMC-BETA
description: Intrathecal allogeneic cell therapy in a blinded syringe
arm group label: Placebo/XCEL-UMC-BETA
arm group label: XCEL-UMC-BETA/placebo
other name: Expanded MSC from Wharton Jelly
intervention type: Drug
intervention name: Placebo
description: Placebo in a blinded syringe
arm group label: Placebo/XCEL-UMC-BETA
arm group label: XCEL-UMC-BETA/placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Joan Vidal, MD, PhD
role: Principal Investigator
affiliation: Hospital de Neurorehabilitació Institut Guttmann
facility: 
country: Spain
url: http://bancsang.net/en_index/
description: Blood and Tissue Bank of Catalonia
url: http://www.guttmann.com/en
description: Hospital de Neurorehabilitació Institut Guttmann
url: http://www.ccma.cat/tv3/marato/en/
description: Marató TV3
responsible party type: Sponsor
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries
sharing ipd: No