<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/NCT04493918</url>
  </required_header>
  <id_info>
    <org_study_id>18-04-0389</org_study_id>
    <nct_id>NCT04493918</nct_id>
  </id_info>
  <brief_title>Effectivity of Mesenchymal Stem Cell on Vertebral Bone Defect Due to Mycobaterium Tuberculosis Infection</brief_title>
  <official_title>Effectivity of Local Implantation of the Mesenchymal Stem Cell on Vertebral Bone Defect Due to Mycobaterium Tuberculosis Infection (Clinical Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ahmad Jabir Rahyussalim</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indonesia University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the effectiveness of locally implantation of mesenchymal stem cell on&#xD;
      vertebral bone defects due to infection of mycobacterium tuberculosis. there are controlled&#xD;
      participants who receives placebo and patients who receives implantation of MSc&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Mesenchymal Stem Cell are implanted in Spinal Tuberculosis patient. MSC has inflammatory&#xD;
      effect and the ability to form into new bone.&#xD;
&#xD;
      In Spinal Tuberculosis, the spread of bacteria is commonly hematogenous, where the focus of&#xD;
      infection is at the anterior part of the vertebrae near the subchondral bone. The infection&#xD;
      process continues, where the necrotic casseous fragments formed into local abcess that may&#xD;
      spread to the sorrounding area.&#xD;
&#xD;
      Patient with spinal tuberculosis who receives Anti TB Drug, is planned to undergo&#xD;
      debridement, spinal stabilization. After thorough debridement, patient who fall into control&#xD;
      group receives normal saline injection, patients who fall into treatment group will receive&#xD;
      Mesenchymal Stem Cell.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 21, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2020</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>
    <masking_description>Participants do not know which treatment they receives. Outcome assessor is a radiologist</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Vertebral bony fusion</measure>
    <time_frame>1 Year</time_frame>
    <description>trabecular bone on xray and CT scan</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Spinal Tuberculosis</condition>
  <condition>Mesenchymal Stem Cell</condition>
  <arm_group>
    <arm_group_label>MSC Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mesenchymal Stem Cell + NaCl 0,9% 2ml</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Mesenchymal Stem cell + Nacl 0.9%</intervention_name>
    <description>Patient who undergo surgery, debridement, decompression and posterior stabilization injection with Nacl 0.9% 2 ml + MSC 30 million unit</description>
    <arm_group_label>MSC Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>NaCl 0.9%</intervention_name>
    <description>Patient who undergo surgery, debridement, decompression and posterior stabilization injection with Nacl 0.9% 2 ml</description>
    <arm_group_label>MSC Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinicoradiologically diagnoses Spinal Tuberculosis&#xD;
&#xD;
          -  receives Anti TB drugs&#xD;
&#xD;
          -  minimun destruction 1/3 vertebral body&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient under 15 years old&#xD;
&#xD;
          -  reject to be included in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ahmad Jabir Rahyussalim, PhD</last_name>
    <phone>+62811819466</phone>
    <email>rahyussalim71@ui.ac.id</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tri Kurniawati, Mrs</last_name>
    <phone>+628121134311</phone>
    <email>trie3k@ui.ac.id</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cipto Mangunkusumo Hospital</name>
      <address>
        <city>Jakarta Pusat</city>
        <state>DKI Jakarta</state>
        <zip>10430</zip>
        <country>Indonesia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ahmad Jabir Rahyussalim, MD,PhD,SpOT</last_name>
      <phone>+62811819466</phone>
      <email>rahyussalim71@ui.ac.id</email>
    </contact>
    <contact_backup>
      <last_name>Trie K Kurniawati, SSi</last_name>
      <phone>+628121134311</phone>
      <email>trie3k@ui.ac.id</email>
    </contact_backup>
    <investigator>
      <last_name>Ahmad Jabir Rahyussalim, MD,PhD,SpOT</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Indonesia</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 30, 2020</last_update_submitted>
  <last_update_submitted_qc>July 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Indonesia University</investigator_affiliation>
    <investigator_full_name>Ahmad Jabir Rahyussalim</investigator_full_name>
    <investigator_title>Dr. dr. Rahyussalim SpOT(K)</investigator_title>
  </responsible_party>
  <keyword>Mycobacterium tuberculosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
    <mesh_term>Latent Tuberculosis</mesh_term>
    <mesh_term>Tuberculosis, Spinal</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/NCT04493918
org study id: 18-04-0389
nct id: NCT04493918
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study evaluates the effectiveness of locally implantation of mesenchymal stem cell on
      vertebral bone defects due to infection of mycobacterium tuberculosis. there are controlled
      participants who receives placebo and patients who receives implantation of MSc
Mesenchymal Stem Cell are implanted in Spinal Tuberculosis patient. MSC has inflammatory
      effect and the ability to form into new bone.

      In Spinal Tuberculosis, the spread of bacteria is commonly hematogenous, where the focus of
      infection is at the anterior part of the vertebrae near the subchondral bone. The infection
      process continues, where the necrotic casseous fragments formed into local abcess that may
      spread to the sorrounding area.

      Patient with spinal tuberculosis who receives Anti TB Drug, is planned to undergo
      debridement, spinal stabilization. After thorough debridement, patient who fall into control
      group receives normal saline injection, patients who fall into treatment group will receive
      Mesenchymal Stem Cell.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: Participants do not know which treatment they receives. Outcome assessor is a radiologist
measure: Vertebral bony fusion
time frame: 1 Year
description: trabecular bone on xray and CT scan
arm group label: MSC Group
arm group type: Experimental
description: Mesenchymal Stem Cell + NaCl 0,9% 2ml
intervention type: Combination Product
intervention name: Mesenchymal Stem cell + Nacl 0.9%
description: Patient who undergo surgery, debridement, decompression and posterior stabilization injection with Nacl 0.9% 2 ml + MSC 30 million unit
arm group label: MSC Group
intervention type: Combination Product
intervention name: NaCl 0.9%
description: Patient who undergo surgery, debridement, decompression and posterior stabilization injection with Nacl 0.9% 2 ml
arm group label: MSC Group
criteria: 
gender: All
minimum age: 15 Years
maximum age: 64 Years
healthy volunteers: No
last name: Ahmad Jabir Rahyussalim, PhD
phone: +62811819466
email: rahyussalim71@ui.ac.id
last name: Tri Kurniawati, Mrs
phone: +628121134311
email: trie3k@ui.ac.id
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Indonesia
responsible party type: Sponsor-Investigator
investigator affiliation: Indonesia University
investigator full name: Ahmad Jabir Rahyussalim
investigator title: Dr. dr. Rahyussalim SpOT(K)
mesh term: Tuberculosis
mesh term: Latent Tuberculosis
mesh term: Tuberculosis, Spinal
sharing ipd: Undecided