<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/NCT01676441</url>
  </required_header>
  <id_info>
    <org_study_id>Cerecellgram-spine</org_study_id>
    <nct_id>NCT01676441</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Autologous Mesenchymal Stem Cells in Chronic Spinal Cord Injury</brief_title>
  <official_title>A Phase II/III Clinical Trial to Evaluate the Safety and Efficacy of Bone Marrow-derived Mesenchymal Stem Cell Transplantation in Patients With Chronic Spinal Cord Injury.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pharmicell Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pharmicell Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase II/III clinical trial is designed to evaluate the safety and efficacy of&#xD;
      autologous Mesenchymal Stem Cells (MSC) transplanted directly into the injured spinal cord.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Principal investigator has performed a clinical trial using autologous MSCs in patients&#xD;
      with cervical spinal cord injury. The results revealed the safety of autologous MSC. This&#xD;
      Phase II, III single-center trial is to assess the safety and efficacy of bone marrow-derived&#xD;
      mesenchymal stem cell transplantation direct to injured spinal cord site via laminectomy.&#xD;
      After recovery from the operation, the subjects receive 4 weeks of physical and occupational&#xD;
      therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    sponsor decision (confidential)&#xD;
  </why_stopped>
  <start_date>August 2008</start_date>
  <completion_date type="Actual">March 4, 2021</completion_date>
  <primary_completion_date type="Actual">March 4, 2021</primary_completion_date>
  <phase>Phase 2/Phase 3</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>
    <intervention_model_description>posterior cervical laminectomy and Mesenchymal stem cells(cellgram-spine) tranplantation.&#xD;
After laminectomy, 1.6X107 and 3.2 X107 Autologous Mesenchymal stem cells is injected into the intramedullary and intrathecal space respectively</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Compared change of Motor Score of the American Spinal Injury Association (ASIA) scale</measure>
    <time_frame>Baseline, post operation(24 hours), 1 month, 3 month, 6 month, 12 month</time_frame>
    <description>Compared Baseline and after 6, 12 months of cell treatment, ASIA motor test analyzes the proportion of patients with a motor grade of more than 2 devision, with a motor grade improving from 2 to 3 and a rise of 5 or more in total score.&#xD;
&lt;American Spinal Injury Association (ASIA) scale&gt; 0 Total paralysis&#xD;
Palpable or visible contraction&#xD;
Active movement, full Range Of Motion(ROM) with gravity eliminated&#xD;
Active movement, full ROM against gravity&#xD;
Active movement, full ROM against gravity and moderate resistance in a muscle specific position&#xD;
(normal) Active movement, full ROM against gravity and full resistance in a functional muscle position expected from an otherwise unimpaired person 5* (normal) Active movement, full ROM against gravity and sufficient resistance to be considered normal if identified inhibiting factors (i.e. pain, disuse) were not present NT Not testable</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensory score of the American Spinal Injury Association (ASIA) scale</measure>
    <time_frame>Baseline, post operation(24 hours), 1 month, 3 month, 6 month, 12 month</time_frame>
    <description>Analyze the difference between the pre and post of the ASIA sensory score by using the Study's pre-test (Wilcoxon's signed test).&#xD;
&lt;American Spinal Injury Association (ASIA) scale&gt; The exam is based on neurological responses, touch and pinprick sensations tested in each dermatome, and strength of the muscles that control key motions on both sides of the body. Sensation is graded on a scale of 0-2: 0 is no sensation, 1 is altered or decreased sensation, and 2 is full sensation. Each side of the body is graded independently. When an area is not available (e.g. because of an amputation or cast), it is recorded as &quot;NT&quot;, &quot;not testable&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electrophysiological change (Motor Evoked Potentials-MEP, Somatosensory Evoked Potentials-SSEP)</measure>
    <time_frame>6 months</time_frame>
    <description>Post 6 months of treatment, the validity is analyzed through patients who have expressed their responses to the electrophysiological test (Motor Evoked Potentials-MEP, Somatosensory Evoked Potentials-SSEP).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRI and Diffusion Tensor Imaging of spinal cord</measure>
    <time_frame>6 months</time_frame>
    <description>Post 6 months of cell treatment, the ratio of patients with changes in magnetic resonance imaging is analyzed.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of adverse events</measure>
    <time_frame>Baseline to 12 months</time_frame>
    <description>Analyze the laboratory, vital sign, ECG, physical exam, medical exam, chest X-ray results from baseline to end of the study for investigate adverse reactions and view safety.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Spinal Cord Injury</condition>
  <arm_group>
    <arm_group_label>cellgram-spine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>posterior cervical laminectomy and Mesenchymal stem cells tranplantation. After laminectomy, 1.6X10^7 and 3.2 X10^7 Autologous Mesenchymal stem cells is injected into the intramedullary and intrathecal space respectively</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>cellgram-spine</intervention_name>
    <description>Mesenchymal stem cells transplantation</description>
    <arm_group_label>cellgram-spine</arm_group_label>
    <other_name>Mesenchymal stem cells</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged between 16-65 years&#xD;
&#xD;
          -  Traumatic spinal cord injury at the level of cervical&#xD;
&#xD;
          -  American Spinal Injury Association Impairment Scale B&#xD;
&#xD;
          -  12 months or more post spinal cord injury subject with stable neurological finding&#xD;
             after more than 1 month rehabilitation therapy&#xD;
&#xD;
          -  No signs of contracture&#xD;
&#xD;
          -  Good physical condition to go through operation&#xD;
&#xD;
          -  Must be willing and able to participate in study procedures with no mental and verbal&#xD;
             problem&#xD;
&#xD;
          -  Able to consent by patients or legal representatives&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Serum SGOT/SGPT &gt; 3 X upper limit of normal or Creatinine &gt; 1.5 X upper limit of&#xD;
             normal&#xD;
&#xD;
          -  Major surgical procedure in the past 3 months&#xD;
&#xD;
          -  Penetrating injury&#xD;
&#xD;
          -  Mechanical ventilation&#xD;
&#xD;
          -  Serious pre-existing medical conditions&#xD;
&#xD;
          -  Recently diagnosed infection (Urinary tract infection, Pneumonia etc)&#xD;
&#xD;
          -  Positive skin test for penicillin&#xD;
&#xD;
          -  Positive result for viral markers (human immunodeficiency virus (HIV), hepatitis B&#xD;
             virus (HBV), hepatitis C virus (HCV) and Venereal Disease Research Laboratory (VDRL)&#xD;
             test)&#xD;
&#xD;
          -  Pregnant women, women of childbearing potential who do not want adequate&#xD;
             contraception, breastfeeding females&#xD;
&#xD;
          -  Unwilling to participate in study&#xD;
&#xD;
          -  Patients with psychiatric disorder severe as to make compliance with the treatment&#xD;
             unlike, and signing informed consent impossible&#xD;
&#xD;
          -  Drug abuse in the past 1 year&#xD;
&#xD;
          -  Participating in other clinical trials in the past 1 month&#xD;
&#xD;
          -  Inappropriate patients to participate in the study according to the chief investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sangryong Jeon, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asan Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Asan medical center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Park JH, Kim DY, Sung IY, Choi GH, Jeon MH, Kim KK, Jeon SR. Long-term results of spinal cord injury therapy using mesenchymal stem cells derived from bone marrow in humans. Neurosurgery. 2012 May;70(5):1238-47; discussion 1247. doi: 10.1227/NEU.0b013e31824387f9.</citation>
    <PMID>22127044</PMID>
  </reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>March 21, 2021</last_update_submitted>
  <last_update_submitted_qc>March 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>spinal cord injury</keyword>
  <keyword>mesenchymal stem cell</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/NCT01676441
org study id: Cerecellgram-spine
nct id: NCT01676441
lead sponsor: 
has dmc: No
This phase II/III clinical trial is designed to evaluate the safety and efficacy of
      autologous Mesenchymal Stem Cells (MSC) transplanted directly into the injured spinal cord.
The Principal investigator has performed a clinical trial using autologous MSCs in patients
      with cervical spinal cord injury. The results revealed the safety of autologous MSC. This
      Phase II, III single-center trial is to assess the safety and efficacy of bone marrow-derived
      mesenchymal stem cell transplantation direct to injured spinal cord site via laminectomy.
      After recovery from the operation, the subjects receive 4 weeks of physical and occupational
      therapy.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: posterior cervical laminectomy and Mesenchymal stem cells(cellgram-spine) tranplantation.
After laminectomy, 1.6X107 and 3.2 X107 Autologous Mesenchymal stem cells is injected into the intramedullary and intrathecal space respectively
primary purpose: Treatment
masking: None (Open Label)
measure: Compared change of Motor Score of the American Spinal Injury Association (ASIA) scale
time frame: Baseline, post operation(24 hours), 1 month, 3 month, 6 month, 12 month
description: Compared Baseline and after 6, 12 months of cell treatment, ASIA motor test analyzes the proportion of patients with a motor grade of more than 2 devision, with a motor grade improving from 2 to 3 and a rise of 5 or more in total score.
<American Spinal Injury Association (ASIA) scale> 0 Total paralysis
Palpable or visible contraction
Active movement, full Range Of Motion(ROM) with gravity eliminated
Active movement, full ROM against gravity
Active movement, full ROM against gravity and moderate resistance in a muscle specific position
(normal) Active movement, full ROM against gravity and full resistance in a functional muscle position expected from an otherwise unimpaired person 5* (normal) Active movement, full ROM against gravity and sufficient resistance to be considered normal if identified inhibiting factors (i.e. pain, disuse) were not present NT Not testable
measure: Sensory score of the American Spinal Injury Association (ASIA) scale
time frame: Baseline, post operation(24 hours), 1 month, 3 month, 6 month, 12 month
description: Analyze the difference between the pre and post of the ASIA sensory score by using the Study's pre-test (Wilcoxon's signed test).
<American Spinal Injury Association (ASIA) scale> The exam is based on neurological responses, touch and pinprick sensations tested in each dermatome, and strength of the muscles that control key motions on both sides of the body. Sensation is graded on a scale of 0-2: 0 is no sensation, 1 is altered or decreased sensation, and 2 is full sensation. Each side of the body is graded independently. When an area is not available (e.g. because of an amputation or cast), it is recorded as "NT", "not testable".
measure: Electrophysiological change (Motor Evoked Potentials-MEP, Somatosensory Evoked Potentials-SSEP)
time frame: 6 months
description: Post 6 months of treatment, the validity is analyzed through patients who have expressed their responses to the electrophysiological test (Motor Evoked Potentials-MEP, Somatosensory Evoked Potentials-SSEP).
measure: MRI and Diffusion Tensor Imaging of spinal cord
time frame: 6 months
description: Post 6 months of cell treatment, the ratio of patients with changes in magnetic resonance imaging is analyzed.
measure: Number of adverse events
time frame: Baseline to 12 months
description: Analyze the laboratory, vital sign, ECG, physical exam, medical exam, chest X-ray results from baseline to end of the study for investigate adverse reactions and view safety.
arm group label: cellgram-spine
arm group type: Experimental
description: posterior cervical laminectomy and Mesenchymal stem cells tranplantation. After laminectomy, 1.6X10^7 and 3.2 X10^7 Autologous Mesenchymal stem cells is injected into the intramedullary and intrathecal space respectively
intervention type: Drug
intervention name: cellgram-spine
description: Mesenchymal stem cells transplantation
arm group label: cellgram-spine
other name: Mesenchymal stem cells
criteria: 
gender: All
minimum age: 16 Years
maximum age: 65 Years
healthy volunteers: No
last name: Sangryong Jeon, MD, PhD
role: Principal Investigator
affiliation: Asan Medical Center
facility: 
country: Korea, Republic of
citation: Park JH, Kim DY, Sung IY, Choi GH, Jeon MH, Kim KK, Jeon SR. Long-term results of spinal cord injury therapy using mesenchymal stem cells derived from bone marrow in humans. Neurosurgery. 2012 May;70(5):1238-47; discussion 1247. doi: 10.1227/NEU.0b013e31824387f9.
PMID: 22127044
responsible party type: Sponsor
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries