<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/NCT04499105</url>
  </required_header>
  <id_info>
    <org_study_id>17-02-0143</org_study_id>
    <nct_id>NCT04499105</nct_id>
  </id_info>
  <brief_title>Effectiveness and Safety of Mesenchymal Stem Cell (MSC) Implantation on Degenerative Discus Disease Patients</brief_title>
  <acronym>MSC</acronym>
  <official_title>Effectiveness and Safety of Allogenic Mesenchymal Stem Cell (MSC) Implantation on Degenerative Discus Disease Patients (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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the effectivity and safety of MSC implantation on Degenerative Disc&#xD;
      Disease Patients by assessing visual analog scale, ROM improvement and MRI examination.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The team plan to conduct research to look at the effectiveness and safety of mesenchymal stem&#xD;
      cell implantation therapy in intervertebral disc degeneration patients.&#xD;
&#xD;
      The use of allogenic mesenchymal stem cells from the umbilical cord was chosen because&#xD;
      patients with degeneration of the intervertebral disc are elderly (over 50 years old) so that&#xD;
      autologous mesenchymal stem cell administration is not possible in terms of taking the source&#xD;
      of cells (bone marrow) nor the quality of mesenchymal stem cells obtained.&#xD;
&#xD;
      This study will assess the improvement of clinical symptoms (VAS to assess pain scale, ASIA&#xD;
      and Frankel scale, as well as assessment of the widening of the lumbar region using the&#xD;
      Schober Test), changes in the structure of the intervertebral discs (through MRI examination&#xD;
      and grading the degree of intervertebral disc degeneration), conduction function spinal cord&#xD;
      nerve (somatosensory evoked potential / SSEP), myelography / EMG, and assessment of the&#xD;
      quality of life status of patients using the Oswestry Disability Index.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 24, 2017</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 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>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement of Low Back Pain</measure>
    <time_frame>6 months</time_frame>
    <description>Evaluates pain quality using Visual Analog Scale (VAS) from 0 - 10. Zero is no pain at all, one is the the least pain and ten is the most painful. The numbers are expected to be lower after MSC implantation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tissue Improvement</measure>
    <time_frame>6 months</time_frame>
    <description>Tissue improvement confirmed by intervertebral disc MRI</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Degenerative Disc Disease</condition>
  <condition>Low Back Pain</condition>
  <condition>Disc Degeneration</condition>
  <arm_group>
    <arm_group_label>Mesenchymal Stem Cell</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mesenchymal Stem cell + Nacl 0.9%</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mesenchymal Stem Cell + NaCl 0,9% 2ml</intervention_name>
    <description>Patients enrolled in Cipto Mangunkusumo Hospital with degenerative disc disease with no promising result after conventional treatment.</description>
    <arm_group_label>Mesenchymal Stem Cell</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients enrolled in Cipto Mangunkusumo Hospital with degenerative disc disease with&#xD;
             no promising result after conventional treatment.&#xD;
&#xD;
          2. No history of metabolic, autoimun and genetic disease(s).&#xD;
&#xD;
          3. No active infection (HbsAg, HIV, CMV, Rubella).&#xD;
&#xD;
          4. Agree to participate the study by signing informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients under 20 years old.&#xD;
&#xD;
          2. Declined to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ahmad Jabir Rahyussalim, PhD, SpOT(K)</last_name>
    <phone>+62811819466</phone>
    <email>rahyussalim71@ui.ac.id</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tri Kurniawati, S.Si</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>August 2020</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>August 4, 2020</last_update_submitted>
  <last_update_submitted_qc>August 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 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>DDD</keyword>
  <keyword>MSC</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intervertebral Disc Degeneration</mesh_term>
    <mesh_term>Low Back Pain</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/NCT04499105
org study id: 17-02-0143
nct id: NCT04499105
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study evaluates the effectivity and safety of MSC implantation on Degenerative Disc
      Disease Patients by assessing visual analog scale, ROM improvement and MRI examination.
The team plan to conduct research to look at the effectiveness and safety of mesenchymal stem
      cell implantation therapy in intervertebral disc degeneration patients.

      The use of allogenic mesenchymal stem cells from the umbilical cord was chosen because
      patients with degeneration of the intervertebral disc are elderly (over 50 years old) so that
      autologous mesenchymal stem cell administration is not possible in terms of taking the source
      of cells (bone marrow) nor the quality of mesenchymal stem cells obtained.

      This study will assess the improvement of clinical symptoms (VAS to assess pain scale, ASIA
      and Frankel scale, as well as assessment of the widening of the lumbar region using the
      Schober Test), changes in the structure of the intervertebral discs (through MRI examination
      and grading the degree of intervertebral disc degeneration), conduction function spinal cord
      nerve (somatosensory evoked potential / SSEP), myelography / EMG, and assessment of the
      quality of life status of patients using the Oswestry Disability Index.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improvement of Low Back Pain
time frame: 6 months
description: Evaluates pain quality using Visual Analog Scale (VAS) from 0 - 10. Zero is no pain at all, one is the the least pain and ten is the most painful. The numbers are expected to be lower after MSC implantation.
measure: Tissue Improvement
time frame: 6 months
description: Tissue improvement confirmed by intervertebral disc MRI
arm group label: Mesenchymal Stem Cell
arm group type: Experimental
description: Mesenchymal Stem cell + Nacl 0.9%
intervention type: Drug
intervention name: Mesenchymal Stem Cell + NaCl 0,9% 2ml
description: Patients enrolled in Cipto Mangunkusumo Hospital with degenerative disc disease with no promising result after conventional treatment.
arm group label: Mesenchymal Stem Cell
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ahmad Jabir Rahyussalim, PhD, SpOT(K)
phone: +62811819466
email: rahyussalim71@ui.ac.id
last name: Tri Kurniawati, S.Si
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: Intervertebral Disc Degeneration
mesh term: Low Back Pain