<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/NCT02981576</url>
  </required_header>
  <id_info>
    <org_study_id>SCIUJCTC</org_study_id>
    <nct_id>NCT02981576</nct_id>
  </id_info>
  <brief_title>Safety and Effectiveness of BM-MSC vs AT-MSC in the Treatment of SCI Patients.</brief_title>
  <official_title>Comparative Evaluation of Safety and Effectiveness of Autologous Bone Marrow Derived Mesenchymal Stem Cells (BM-MSC) vs Adipose Tissue Derived Mesenchymal Stem Cells (AT-MSC) in the Treatment of Spinal Cord Injury (SCI) Patient.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Jordan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Jordan</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Spinal Cord Injury (SCI) is a devastating condition that leads to permanent functional and&#xD;
      neurological deficits in injured individuals. The limited ability of the Central Nervous&#xD;
      System (CNS) to spontaneously regenerate impairs axonal regeneration and functional recovery&#xD;
      of the spinal cord. The leading causes are motor-vehicle crashes, sports-associated&#xD;
      accidents, falls, and violence-related injuries.&#xD;
&#xD;
      Unfortunately, there is still no effective clinical treatment for SCI. In recent years,&#xD;
      tissue engineering and regenerative medicine based approaches have been proposed as&#xD;
      alternatives for SCI repair/regeneration. Mesnchymal stem cells (MSC) use in SCI showed&#xD;
      promising results in several studies. Our aim is to assess and compare the safety and&#xD;
      effectiveness of autologous BM-MSC vs autologous AT-MSC in these patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be conducted at Cell Therapy Center (CTC) in Jordan, where 14 SCI patients&#xD;
      meeting the inclusion criteria will be recruited and blindly divided into 2 groups of equal&#xD;
      numbers. The first groups will be treated with autologous BM-MSC, while the second group will&#xD;
      be treated with autologous AT-MSC. The outcomes and improvements will be assessed using the&#xD;
      American Spinal Injury Association (ASIA) Impairment Scale (AIS). Magnetic Resonance Imaging&#xD;
      (MRI) will be performed at base line and after 12 months of the stem cell transplantation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">January 20, 2019</completion_date>
  <primary_completion_date type="Actual">May 5, 2018</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparing the number of side effects and the improvement on ASIA Impairment score between SCI patients receiving autologous AT-MSC vs BM-MSC.</measure>
    <time_frame>12 months</time_frame>
    <description>Comparing the number of SCI patients with any relevant side effects observed and the measured outcome in each arm by follow up Magnetic Resonance Imaging (MRI) and clinical signs and symptoms using ASIA scoring system..</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Investigating the number of side effects in SCI patients receiving autologous BM-MSC.</measure>
    <time_frame>12 months</time_frame>
    <description>Assessing the number of SCI patients with any relevant side effects observed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigating the effectiveness of autologous BM-MSC in treating SCI patients.</measure>
    <time_frame>12 months</time_frame>
    <description>Assessing the therapeutic benefits of the injected Autologous BM-MSC by follow up Magnetic Resonance Imaging (MRI) and clinical signs and symptoms using ASIA scoring system.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigating the number of side effects in SCI patients receiving autologous AT-MSC.</measure>
    <time_frame>12 months</time_frame>
    <description>Assessing the number of SCI patients with any relevant side effects observed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigating the effectiveness of autologous AT-MSC in treating SCI patients.</measure>
    <time_frame>12 months</time_frame>
    <description>Assessing the therapeutic benefits of the injected Autologous AT-MSC by follow up Magnetic Resonance Imaging (MRI) and clinical signs and symptoms using ASIA scoring system.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <arm_group>
    <arm_group_label>Recipient of AT-MSC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients who will receive Autologous Mesenchymal Stem Cells from AdiposeTissue by Intrathecal injection of stem cells that will be performed 3 times.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Recipient of BM-MSC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients who will receive Autologous Mesenchymal Stem Cells from Bone marrow by Intrathecal injection of stem cells that will be performed 3 times.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Autologous Mesenchymal Stem Cells</intervention_name>
    <description>Autologous Mesenchymal Stem Cells will be collected from patients, prepared in the lab and then injected intrathecally.</description>
    <arm_group_label>Recipient of AT-MSC</arm_group_label>
    <arm_group_label>Recipient of BM-MSC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Complete spinal cord injury grade AIS-A or -B, or incomplete C&#xD;
&#xD;
          -  At least 2 weeks since time of injury&#xD;
&#xD;
          -  Cognitively unaffected&#xD;
&#xD;
          -  Motivated for stem cell transplantation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Reduced cognition&#xD;
&#xD;
          -  Age under 18 years of above 70 years&#xD;
&#xD;
          -  Significant osteoporosis in spine and/or joints&#xD;
&#xD;
          -  Pregnancy (Adequate contraceptive use is required for women in fertile age)&#xD;
&#xD;
          -  Anoxic brain injury&#xD;
&#xD;
          -  Neurodegenerative diseases&#xD;
&#xD;
          -  Evidence of meningitis&#xD;
&#xD;
          -  Positive serology for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV),&#xD;
             Hepatitis C Virus (HCV), or Syphilis.&#xD;
&#xD;
          -  Medical Complications that contraindicate surgery, including major respiratory&#xD;
             complications.&#xD;
&#xD;
          -  Use of metal implants close to vascular structures (such as cardiac pacemaker or&#xD;
             prosthesis) that contraindicate Magnetic resonance imaging (MRI).&#xD;
&#xD;
          -  Other medical conditions which can interfere with stem cell transplantation&#xD;
&#xD;
          -  Inability to provide informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Abdalla Awidi, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Jordan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cell Therapy Center, University of Jordan</name>
      <address>
        <city>Amman</city>
        <zip>11942</zip>
        <country>Jordan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Jordan</country>
  </location_countries>
  <link>
    <url>http://centers.ju.edu.jo/en/ctc/Home.aspx</url>
    <description>Cell Therapy Center Website</description>
  </link>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>September 23, 2019</last_update_submitted>
  <last_update_submitted_qc>September 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Jordan</investigator_affiliation>
    <investigator_full_name>Fatima Jamali</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Spinal Cord Injury</keyword>
  <keyword>Mesenchymal 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>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02981576
org study id: SCIUJCTC
nct id: NCT02981576
lead sponsor: 
has dmc: Yes
Spinal Cord Injury (SCI) is a devastating condition that leads to permanent functional and
      neurological deficits in injured individuals. The limited ability of the Central Nervous
      System (CNS) to spontaneously regenerate impairs axonal regeneration and functional recovery
      of the spinal cord. The leading causes are motor-vehicle crashes, sports-associated
      accidents, falls, and violence-related injuries.

      Unfortunately, there is still no effective clinical treatment for SCI. In recent years,
      tissue engineering and regenerative medicine based approaches have been proposed as
      alternatives for SCI repair/regeneration. Mesnchymal stem cells (MSC) use in SCI showed
      promising results in several studies. Our aim is to assess and compare the safety and
      effectiveness of autologous BM-MSC vs autologous AT-MSC in these patients.
The study will be conducted at Cell Therapy Center (CTC) in Jordan, where 14 SCI patients
      meeting the inclusion criteria will be recruited and blindly divided into 2 groups of equal
      numbers. The first groups will be treated with autologous BM-MSC, while the second group will
      be treated with autologous AT-MSC. The outcomes and improvements will be assessed using the
      American Spinal Injury Association (ASIA) Impairment Scale (AIS). Magnetic Resonance Imaging
      (MRI) will be performed at base line and after 12 months of the stem cell transplantation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Comparing the number of side effects and the improvement on ASIA Impairment score between SCI patients receiving autologous AT-MSC vs BM-MSC.
time frame: 12 months
description: Comparing the number of SCI patients with any relevant side effects observed and the measured outcome in each arm by follow up Magnetic Resonance Imaging (MRI) and clinical signs and symptoms using ASIA scoring system..
measure: Investigating the number of side effects in SCI patients receiving autologous BM-MSC.
time frame: 12 months
description: Assessing the number of SCI patients with any relevant side effects observed.
measure: Investigating the effectiveness of autologous BM-MSC in treating SCI patients.
time frame: 12 months
description: Assessing the therapeutic benefits of the injected Autologous BM-MSC by follow up Magnetic Resonance Imaging (MRI) and clinical signs and symptoms using ASIA scoring system.
measure: Investigating the number of side effects in SCI patients receiving autologous AT-MSC.
time frame: 12 months
description: Assessing the number of SCI patients with any relevant side effects observed.
measure: Investigating the effectiveness of autologous AT-MSC in treating SCI patients.
time frame: 12 months
description: Assessing the therapeutic benefits of the injected Autologous AT-MSC by follow up Magnetic Resonance Imaging (MRI) and clinical signs and symptoms using ASIA scoring system.
arm group label: Recipient of AT-MSC
arm group type: Active Comparator
description: Patients who will receive Autologous Mesenchymal Stem Cells from AdiposeTissue by Intrathecal injection of stem cells that will be performed 3 times.
arm group label: Recipient of BM-MSC
arm group type: Active Comparator
description: Patients who will receive Autologous Mesenchymal Stem Cells from Bone marrow by Intrathecal injection of stem cells that will be performed 3 times.
intervention type: Biological
intervention name: Autologous Mesenchymal Stem Cells
description: Autologous Mesenchymal Stem Cells will be collected from patients, prepared in the lab and then injected intrathecally.
arm group label: Recipient of AT-MSC
arm group label: Recipient of BM-MSC
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Abdalla Awidi, MD
role: Study Chair
affiliation: University of Jordan
facility: 
country: Jordan
url: http://centers.ju.edu.jo/en/ctc/Home.aspx
description: Cell Therapy Center Website
responsible party type: Principal Investigator
investigator affiliation: University of Jordan
investigator full name: Fatima Jamali
investigator title: Principal Investigator
mesh term: Spinal Cord Injuries
sharing ipd: Undecided