<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/NCT01694927</url>
  </required_header>
  <id_info>
    <org_study_id>LIT-2012-ACF-001</org_study_id>
    <nct_id>NCT01694927</nct_id>
  </id_info>
  <brief_title>Autologous Mesenchymal Stem Cells in Spinal Cord Injury (SCI) Patients</brief_title>
  <acronym>MSC-SCI</acronym>
  <official_title>Autologous Mesenchymal Stem Cells in Spinal Cord Injury (SCI) Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clínica Las Condes. LIT INNOVA CORFO</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinica las Condes, Chile</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the use of autologous expanded mesenchymal stem cells&#xD;
      intralesional transplantation as a safe and potentially beneficial treatment for patients&#xD;
      with spinal cord injury.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>January 2012</start_date>
  <completion_date type="Anticipated">June 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2013</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety of Autologous Expanded Mesenchymal Stem Cells transplantation in SCI patients</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional improvement in muscle strength</measure>
    <time_frame>1 year</time_frame>
    <description>According to motor index score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Improvement in sphincters control</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional improvement in spasticity control</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Spinal Cord Injury</condition>
  <arm_group>
    <arm_group_label>Mesenchymal Stem cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Autologous Mesenchymal Stem Cells</intervention_name>
    <description>Expanded Intralesional Autologous Mesenchymal Stem Cells Transplantation</description>
    <arm_group_label>Mesenchymal Stem cells</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Spinal Injury Association Impairment (ASIA) Scale A, B and C&#xD;
&#xD;
          -  Cervical (under C4), thoracic o lumbar spine lesion&#xD;
&#xD;
          -  Complete or Incomplete SCI&#xD;
&#xD;
          -  Platelet count over 100.000/ul&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute SCI (less than 3 months)&#xD;
&#xD;
          -  Active infectious diseases&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Neurodegenerative diseases&#xD;
&#xD;
          -  Primary hematologic diseases&#xD;
&#xD;
          -  Coagulopathies&#xD;
&#xD;
          -  Hepatic dysfunction&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrés Chahín, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clínica Las Condes, Santiago</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rodrigo M Mardones, MD</last_name>
    <role>Study Director</role>
    <affiliation>Clínica Las Condes, Santiago</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Catalina Larrain, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Clínica Las Condes, Santiago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clínica Las Condes</name>
      <address>
        <city>Santiago</city>
        <state>RM</state>
        <zip>7591468</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <results_reference>
    <citation>Pal R, Venkataramana NK, Bansal A, Balaraju S, Jan M, Chandra R, Dixit A, Rauthan A, Murgod U, Totey S. Ex vivo-expanded autologous bone marrow-derived mesenchymal stromal cells in human spinal cord injury/paraplegia: a pilot clinical study. Cytotherapy. 2009;11(7):897-911. doi: 10.3109/14653240903253857.</citation>
    <PMID>19903102</PMID>
  </results_reference>
  <results_reference>
    <citation>Ra JC, Shin IS, Kim SH, Kang SK, Kang BC, Lee HY, Kim YJ, Jo JY, Yoon EJ, Choi HJ, Kwon E. Safety of intravenous infusion of human adipose tissue-derived mesenchymal stem cells in animals and humans. Stem Cells Dev. 2011 Aug;20(8):1297-308. doi: 10.1089/scd.2010.0466. Epub 2011 Mar 17.</citation>
    <PMID>21303266</PMID>
  </results_reference>
  <results_reference>
    <citation>Moviglia GA, Fernandez Vina R, Brizuela JA, Saslavsky J, Vrsalovic F, Varela G, Bastos F, Farina P, Etchegaray G, Barbieri M, Martinez G, Picasso F, Schmidt Y, Brizuela P, Gaeta CA, Costanzo H, Moviglia Brandolino MT, Merino S, Pes ME, Veloso MJ, Rugilo C, Tamer I, Shuster GS. Combined protocol of cell therapy for chronic spinal cord injury. Report on the electrical and functional recovery of two patients. Cytotherapy. 2006;8(3):202-9. doi: 10.1080/14653240600736048.</citation>
    <PMID>16793729</PMID>
  </results_reference>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>July 2, 2013</last_update_submitted>
  <last_update_submitted_qc>July 2, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 3, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Clinica las Condes, Chile</investigator_affiliation>
    <investigator_full_name>Clínica Las Condes. LIT INNOVA CORFO</investigator_full_name>
    <investigator_title>Clinical Researcher LIT. Innova CORFO 09IEI6568</investigator_title>
  </responsible_party>
  <keyword>Mesenchymal stem cell</keyword>
  <keyword>Spinal cord injury</keyword>
  <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>
  <!-- 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/NCT01694927
org study id: LIT-2012-ACF-001
nct id: NCT01694927
lead sponsor: 
has dmc: No
The aim of this study is to evaluate the use of autologous expanded mesenchymal stem cells
      intralesional transplantation as a safe and potentially beneficial treatment for patients
      with spinal cord injury.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety of Autologous Expanded Mesenchymal Stem Cells transplantation in SCI patients
time frame: 3 months
measure: Functional improvement in muscle strength
time frame: 1 year
description: According to motor index score
measure: Functional Improvement in sphincters control
time frame: 1 year
measure: Functional improvement in spasticity control
time frame: 1 year
arm group label: Mesenchymal Stem cells
arm group type: Experimental
intervention type: Procedure
intervention name: Autologous Mesenchymal Stem Cells
description: Expanded Intralesional Autologous Mesenchymal Stem Cells Transplantation
arm group label: Mesenchymal Stem cells
criteria: 
gender: All
minimum age: 2 Years
maximum age: 65 Years
healthy volunteers: No
last name: Andrés Chahín, MD
role: Principal Investigator
affiliation: Clínica Las Condes, Santiago
last name: Rodrigo M Mardones, MD
role: Study Director
affiliation: Clínica Las Condes, Santiago
last name: Catalina Larrain, MD
role: Study Chair
affiliation: Clínica Las Condes, Santiago
facility: 
country: Chile
citation: Pal R, Venkataramana NK, Bansal A, Balaraju S, Jan M, Chandra R, Dixit A, Rauthan A, Murgod U, Totey S. Ex vivo-expanded autologous bone marrow-derived mesenchymal stromal cells in human spinal cord injury/paraplegia: a pilot clinical study. Cytotherapy. 2009;11(7):897-911. doi: 10.3109/14653240903253857.
PMID: 19903102
citation: Ra JC, Shin IS, Kim SH, Kang SK, Kang BC, Lee HY, Kim YJ, Jo JY, Yoon EJ, Choi HJ, Kwon E. Safety of intravenous infusion of human adipose tissue-derived mesenchymal stem cells in animals and humans. Stem Cells Dev. 2011 Aug;20(8):1297-308. doi: 10.1089/scd.2010.0466. Epub 2011 Mar 17.
PMID: 21303266
citation: Moviglia GA, Fernandez Vina R, Brizuela JA, Saslavsky J, Vrsalovic F, Varela G, Bastos F, Farina P, Etchegaray G, Barbieri M, Martinez G, Picasso F, Schmidt Y, Brizuela P, Gaeta CA, Costanzo H, Moviglia Brandolino MT, Merino S, Pes ME, Veloso MJ, Rugilo C, Tamer I, Shuster GS. Combined protocol of cell therapy for chronic spinal cord injury. Report on the electrical and functional recovery of two patients. Cytotherapy. 2006;8(3):202-9. doi: 10.1080/14653240600736048.
PMID: 16793729
responsible party type: Sponsor-Investigator
investigator affiliation: Clinica las Condes, Chile
investigator full name: Clínica Las Condes. LIT INNOVA CORFO
investigator title: Clinical Researcher LIT. Innova CORFO 09IEI6568
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries