<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/NCT01725698</url>
  </required_header>
  <id_info>
    <org_study_id>SCNONUNION12</org_study_id>
    <nct_id>NCT01725698</nct_id>
  </id_info>
  <brief_title>The Combined Effect of Mesenchymal Stem Cell, HA-CaSO4,BMP-2, and Implant in Inducing The Healing of Critical-Sized Bone Defect</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indonesia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indonesia University</source>
  <brief_summary>
    <textblock>
      This research is aimed to evaluate the combination of mesenchymal stem cell, HA-CaSO4, BMP-2,&#xD;
      and implant in treating critical-sized bone defect.&#xD;
&#xD;
      In the presence of critical-sized bone defect whose defect size is more than 2.5 cm, bone&#xD;
      will suffer a healing disturbance. In treating these conditions, the conventional method were&#xD;
      vascularised bone grafting and bone transport. But the existing methods of treatment have&#xD;
      many weaknesses Vascularized bone graft is a procedure with a high level of difficulty. Hence&#xD;
      not every orthopaedic surgeon were able to perform it. It also takes more operating time and&#xD;
      its failure rate is also quite high.&#xD;
&#xD;
      Meanwhile, external fixation which is applied with bone transport, was being often complained&#xD;
      by the patient in terms of cosmetic and psychologically.&#xD;
&#xD;
      According to diamond concept of bone healing, there are four main factors that influence the&#xD;
      bone healing. These factors are osteogenic factor (mesenchymal stem cell), osteconductive&#xD;
      factor (HA-CaSO4), osteoinductive factor (bone morphogenetic protein-2) and mechanical&#xD;
      component (implant). The potency of each component in fracture healing with/out bone defect&#xD;
      has been proved in many studies. The combined effect of these components is often studied as&#xD;
      well, but not in critical-sized bone defect.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <phase>Phase 1</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>RADIOGRAPHIC UNION SCALE (RUST Score) as a measure of bone union</measure>
    <time_frame>Before surgery, after surgery, week 4 , 8, 12, 16, 20, 24 up to 1.5 years</time_frame>
    <description>plain radiograps will be taken to determine whether the bone has healed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual analog scale as the measure of clinical union</measure>
    <time_frame>Before surgery, after surgery, week 4 , 8, 12, 16, 20, 24 up to 1.5 years</time_frame>
    <description>We will measure VAS (grade 0-10) to determine the clinical union</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">5</enrollment>
  <condition>Union</condition>
  <arm_group>
    <arm_group_label>Stemcell</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mesenchymal stem cell, HA-CaSO4, ¬BMP-2, and Implant</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mesenchymal stem cell, HA-CaSO4, ¬BMP-2, and Implant</intervention_name>
    <arm_group_label>Stemcell</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  subjects with critical size defect of bone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects with patological fracture caused by primary or secondary bone malignancy,&#xD;
             imunological deficit, active hepatitis or those who's under immunosuppresant therapy&#xD;
             or other therapeutic modality that can interferes with bone healing.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Indonesia, National University of Singapore</name>
      <address>
        <city>Jakarta, Singapore</city>
        <state>Indonesia, Singapore</state>
        <zip>14430</zip>
        <country>Indonesia</country>
      </address>
    </facility>
    <contact>
      <last_name>Ismail, PhD</last_name>
      <phone>+628561961498</phone>
    </contact>
  </location>
  <location_countries>
    <country>Indonesia</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 7, 2012</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>November 8, 2012</last_update_submitted>
  <last_update_submitted_qc>November 8, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 14, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indonesia University</investigator_affiliation>
    <investigator_full_name>Ismail Hadisoebroto Dilogo</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <!-- 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/NCT01725698
org study id: SCNONUNION12
nct id: NCT01725698
lead sponsor: 
This research is aimed to evaluate the combination of mesenchymal stem cell, HA-CaSO4, BMP-2,
      and implant in treating critical-sized bone defect.

      In the presence of critical-sized bone defect whose defect size is more than 2.5 cm, bone
      will suffer a healing disturbance. In treating these conditions, the conventional method were
      vascularised bone grafting and bone transport. But the existing methods of treatment have
      many weaknesses Vascularized bone graft is a procedure with a high level of difficulty. Hence
      not every orthopaedic surgeon were able to perform it. It also takes more operating time and
      its failure rate is also quite high.

      Meanwhile, external fixation which is applied with bone transport, was being often complained
      by the patient in terms of cosmetic and psychologically.

      According to diamond concept of bone healing, there are four main factors that influence the
      bone healing. These factors are osteogenic factor (mesenchymal stem cell), osteconductive
      factor (HA-CaSO4), osteoinductive factor (bone morphogenetic protein-2) and mechanical
      component (implant). The potency of each component in fracture healing with/out bone defect
      has been proved in many studies. The combined effect of these components is often studied as
      well, but not in critical-sized bone defect.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: RADIOGRAPHIC UNION SCALE (RUST Score) as a measure of bone union
time frame: Before surgery, after surgery, week 4 , 8, 12, 16, 20, 24 up to 1.5 years
description: plain radiograps will be taken to determine whether the bone has healed.
measure: Visual analog scale as the measure of clinical union
time frame: Before surgery, after surgery, week 4 , 8, 12, 16, 20, 24 up to 1.5 years
description: We will measure VAS (grade 0-10) to determine the clinical union
arm group label: Stemcell
arm group type: Experimental
description: Mesenchymal stem cell, HA-CaSO4, ¬BMP-2, and Implant
intervention type: Drug
intervention name: Mesenchymal stem cell, HA-CaSO4, ¬BMP-2, and Implant
arm group label: Stemcell
criteria: 
gender: All
minimum age: 17 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
contact: 
country: Indonesia
responsible party type: Principal Investigator
investigator affiliation: Indonesia University
investigator full name: Ismail Hadisoebroto Dilogo
investigator title: PhD