<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/NCT04501354</url>
  </required_header>
  <id_info>
    <org_study_id>19-08-1018</org_study_id>
    <nct_id>NCT04501354</nct_id>
  </id_info>
  <brief_title>Evaluation of Clinical and Bone Density Improvement After Implantation of Allogenic Mesenchymal Stem Cell From Umbilical Cord on Osteoporosis Patients</brief_title>
  <official_title>Evaluation of Clinical and Bone Density Improvement After Implantation of Allogenic Mesenchymal Stem Cell From Umbilical Cord on Osteoporosis 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 will assess the effectiveness of the allogeneic mesenchymal cell from umbilical&#xD;
      cord in improving the quality and quantity of spinal density of osteoporosis patients proven&#xD;
      by the results of Bone Mass Density (BMD) examination compared to baseline and evaluate&#xD;
      improvement of quality of pain with visual analog scale (VAS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Currently, preventive and therapeutic strategies for osteoporosis patients are based on&#xD;
      calcium and vitamin D supplementation, the use of pharmacological agents that inhibit bone&#xD;
      resorption such as bisphosphonates, and sometimes calcitonin. Although bisphosphonates have&#xD;
      been found to reduce osteoporosis, clinical use for these drugs has been limited because of&#xD;
      its potential to produce serious side effects, such as mandibular osteonecrosis and atypical&#xD;
      femoral fractures. Therefore, new therapeutic strategies for osteoporosis are needed.&#xD;
&#xD;
      This study will assess the effectiveness of the allogeneic mesenchymal cell from umbilical&#xD;
      cord. Patients who have received mesenchymal stem cell therapy (MSC) are expected to have&#xD;
      positive effects such as reduced pain sensation in the back assessed by Visual Analog Scale&#xD;
      (VAS), improvement in the range of motion (ROM), improving the quality of osteoporosis&#xD;
      patients's bone proven by the results of Bone Mass Density (BMD) and improvement in patients'&#xD;
      quality of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">August 2020</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>Bone Mass Density (BMD)</measure>
    <time_frame>6 months</time_frame>
    <description>Improvement of spinal density in osteoporosis patients proven by the results of Bone Mass Density (BMD).&#xD;
Above Standard Deviation (SD) (-1) means normal&#xD;
Between SD (-1) and (-2.5) is classified as osteopenia. Osteopenia is a condition when bone density is lower than the average, but not as low as osteoporosis.&#xD;
Below SD (-2.5) is categorized as osteoporosis.&#xD;
The numbers are expected to be higher after MSC implantation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analog Scale (VAS)</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>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">5</enrollment>
  <condition>Osteoporosis</condition>
  <arm_group>
    <arm_group_label>UC-Mesenchymal Stem Cell</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Allogeneic Mesenchymal Stem Cell from umbilical cord</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mesenchymal Stem Cell</intervention_name>
    <description>Mesenchymal Stem Cell + NaCl 0,9% 2ml</description>
    <arm_group_label>UC-Mesenchymal Stem Cell</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male patients older than 50 yrs old.&#xD;
&#xD;
          2. Female patients older than 40 years old.&#xD;
&#xD;
          3. Patients enrolled in Cipto Mangunkusumo Hospital with osteoporosis confirmed by BMD&#xD;
             test.&#xD;
&#xD;
          4. Patients with no history of autoimun disease (SLE, Addison's disease, Chron's disease)&#xD;
             and other diseases related to osteoporosis.&#xD;
&#xD;
          5. Patients with no history of consuming drug related osteoporosis.&#xD;
&#xD;
          6. No active infection confirmed by HbsAg, HIV, CMV, Rubella and Toxoplasma examination.&#xD;
&#xD;
          7. Agree to participate the study by signing informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with autoimun diesasde (SLE, Addison's diesase, Chron's disease and other&#xD;
             osteoporosis related disease.&#xD;
&#xD;
          2. Patients under immunosuppressive, anticoagulant or corticosteroid treatment.&#xD;
&#xD;
          3. Paralysis patients after surgical treatment&#xD;
&#xD;
          4. Patients under 20 years old&#xD;
&#xD;
          5. Declined to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ahmad Jabir Rahyussalim</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>August 2, 2020</study_first_submitted>
  <study_first_submitted_qc>August 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 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>Orthopaedic and Traumatology Specialist, Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</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/NCT04501354
org study id: 19-08-1018
nct id: NCT04501354
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will assess the effectiveness of the allogeneic mesenchymal cell from umbilical
      cord in improving the quality and quantity of spinal density of osteoporosis patients proven
      by the results of Bone Mass Density (BMD) examination compared to baseline and evaluate
      improvement of quality of pain with visual analog scale (VAS).
Currently, preventive and therapeutic strategies for osteoporosis patients are based on
      calcium and vitamin D supplementation, the use of pharmacological agents that inhibit bone
      resorption such as bisphosphonates, and sometimes calcitonin. Although bisphosphonates have
      been found to reduce osteoporosis, clinical use for these drugs has been limited because of
      its potential to produce serious side effects, such as mandibular osteonecrosis and atypical
      femoral fractures. Therefore, new therapeutic strategies for osteoporosis are needed.

      This study will assess the effectiveness of the allogeneic mesenchymal cell from umbilical
      cord. Patients who have received mesenchymal stem cell therapy (MSC) are expected to have
      positive effects such as reduced pain sensation in the back assessed by Visual Analog Scale
      (VAS), improvement in the range of motion (ROM), improving the quality of osteoporosis
      patients's bone proven by the results of Bone Mass Density (BMD) and improvement in patients'
      quality of life.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Bone Mass Density (BMD)
time frame: 6 months
description: Improvement of spinal density in osteoporosis patients proven by the results of Bone Mass Density (BMD).
Above Standard Deviation (SD) (-1) means normal
Between SD (-1) and (-2.5) is classified as osteopenia. Osteopenia is a condition when bone density is lower than the average, but not as low as osteoporosis.
Below SD (-2.5) is categorized as osteoporosis.
The numbers are expected to be higher after MSC implantation.
measure: Visual Analog Scale (VAS)
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.
arm group label: UC-Mesenchymal Stem Cell
arm group type: Experimental
description: Allogeneic Mesenchymal Stem Cell from umbilical cord
intervention type: Drug
intervention name: Mesenchymal Stem Cell
description: Mesenchymal Stem Cell + NaCl 0,9% 2ml
arm group label: UC-Mesenchymal Stem Cell
criteria: 
gender: All
gender based: Yes
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Ahmad Jabir Rahyussalim
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: Orthopaedic and Traumatology Specialist, Principal Investigator
mesh term: Osteoporosis