<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/NCT03793530</url>
  </required_header>
  <id_info>
    <org_study_id>RD106050</org_study_id>
    <nct_id>NCT03793530</nct_id>
  </id_info>
  <brief_title>Autologous Bone Marrow Concentrate in Elective Tranforaminal Lumbar Interbody Fusion Surgery</brief_title>
  <official_title>The Use of Bone Marrow Concentrate in Elective Tranforaminal Lumbar Interbody Fusion Surgery: A Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pei-Yuan Lee, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aeon Biotechnology Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Show Chwan Memorial Hospital</source>
  <oversight_info>
    <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 aims to evaluate the effect of bone marrow concentration on bone healing and&#xD;
      spinal fusion by comparing clinical and imaging outcomes between patients receiving&#xD;
      transforaminal lumbar intebody fusion with local bone graft and with intraoperative bone&#xD;
      marrow concentration and those receiving transforaminal lumbar intebody fusion with local&#xD;
      bone graft only.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Spinal arthrodesis has become the mainstay of treatment for severe spinal deformity, spinal&#xD;
      instability, spondylolisthesis, and symptomatic degenerative disease. Its primary goal is to&#xD;
      develop an osseous bridge between adjacent motion segments to prevent motion, relieve pain,&#xD;
      and facilitate neurological recovery. One of the arthrodesis method is transforaminal lumbar&#xD;
      intebody fusion. After removal of the problematic disc, iliac crest bone graft was harvested&#xD;
      and impacted into the space with cage to facilitate fusion. However, patients are exposed to&#xD;
      additional risk of harvesting site, such as pain, infection, wound healing problem or&#xD;
      hematomas. Local bone graft harvested from decompression is one of the alternative solutions&#xD;
      to avoid these complications. However, the effect of local boen graft is inferior to iliac&#xD;
      crest bone graft because iliac crest bone graft contains three important ingredients for&#xD;
      successful fusion: osteoconductive scaffold, osteoinductive factors, and the ability to&#xD;
      osteogenesis. Mesenchymal stem cells (MSCs) are pluripotent cells that can differentiate into&#xD;
      multiple mesenchymal tissues, including tenocytes, chondrocytes and osteoblasts, as well as&#xD;
      being a source of multiple growth factors to establish an environment conducive to soft and&#xD;
      hard tissue regeneration. As bone marrow concentration has high concentration of mesenchymal&#xD;
      stem cells, some studies have shown that autologous bone marrow concentration can improve&#xD;
      bone healing. In this study, we will add bone marrow concentration into local bone graft&#xD;
      during transforaminal lumbar intebody fusion and evaluate the effect of bone marrow&#xD;
      concentration on bone healing and spinal fusion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>3-month postoperative spinal function evaluated by Oswestry Disability Index</measure>
    <time_frame>3-month postoperative</time_frame>
    <description>Subjective evaluation of spinal function by Oswestry Disability Index. Oswestry Disability Index ranges from 0 to 100 and lower score indicates less disability.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>6-month postoperative spinal function evaluated by Oswestry Disability Index</measure>
    <time_frame>6-month postoperative</time_frame>
    <description>Subjective evaluation of spinal function by Oswestry Disability Index. Oswestry Disability Index ranges from 0 to 100 and lower score indicates less disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>12-month postoperative spinal function evaluated by Oswestry Disability Index</measure>
    <time_frame>12-month postoperative</time_frame>
    <description>Subjective evaluation of spinal function by Oswestry Disability Index. Oswestry Disability Index ranges from 0 to 100 and lower score indicates less disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-month postoperative degree of pain evaluated by visual analogue scale</measure>
    <time_frame>3-month postoperative</time_frame>
    <description>Subjective evaluation of degree of pain by visual analogue scale. Visual analogue scale for pain ranges from 0 to 10 and higher score indicates more pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6-month postoperative degree of pain evaluated by visual analogue scale</measure>
    <time_frame>6-month postoperative</time_frame>
    <description>Subjective evaluation of degree of pain by visual analogue scale. Visual analogue scale for pain ranges from 0 to 10 and higher score indicates more pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>12-month postoperative degree of pain evaluated by visual analogue scale</measure>
    <time_frame>12-month postoperative</time_frame>
    <description>Subjective evaluation of degree of pain by visual analogue scale. Visual analogue scale for pain ranges from 0 to 10 and higher score indicates more pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-month postoperative degree of bone healing evaluated by plain radiograph</measure>
    <time_frame>3-month postoperative</time_frame>
    <description>Degree of bone healing evaluated by plain radiograph</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6-month postoperative degree of bone healing evaluated by plain radiograph</measure>
    <time_frame>6-month postoperative</time_frame>
    <description>Degree of bone healing evaluated by plain radiograph</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>12-month postoperative degree of bone healing evaluated by plain radiograph</measure>
    <time_frame>12-month postoperative</time_frame>
    <description>Degree of bone healing evaluated by plain radiograph</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>12-month postoperative degree of bone healing evaluated by computed tomograph</measure>
    <time_frame>12-month postoperative</time_frame>
    <description>Degree of bone healing evaluated by computed tomograph</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Bone Marrow</condition>
  <condition>Spinal Fusion</condition>
  <arm_group>
    <arm_group_label>Bone marrow concentration group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transforaminal lumbar interbody fusion with local bone graft and intraoperative bone marrow concentration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Transforaminal lumbar interbody fusion with local bone graft</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Transforaminal lumbar interbody fusion with local bone graft and intraoperative bone marrow concentration</intervention_name>
    <description>Transforaminal lumbar interbody fusion with local bone graft and intraoperative bone marrow concentration</description>
    <arm_group_label>Bone marrow concentration group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Transforaminal lumbar interbody fusion with local bone graft</intervention_name>
    <description>Transforaminal lumbar interbody fusion with local bone graft</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  With indication of transforaminal lumbar decomprassion and interbody fusion, ex.&#xD;
             spondylolisthesis, symptomatic degenerative disease, spinal instability.&#xD;
&#xD;
          -  Involved levels between T12 and S1&#xD;
&#xD;
          -  Involved levels less than three levels&#xD;
&#xD;
          -  Age between 20 and 70 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  With prior history of spinal surgery&#xD;
&#xD;
          -  With current or prior history of tumor, trauma or infection at spine&#xD;
&#xD;
          -  With current diagnosis of coagulopathy&#xD;
&#xD;
          -  With current or prior history of cancer&#xD;
&#xD;
          -  With current or prior history of hematological disease&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Patients who will not cooperate with one-year followup&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pei-Yuan Lee, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Show Chwan Memorial Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ming-Hsien Hu, MD</last_name>
    <phone>+886-975611289</phone>
    <email>minghsienhu@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Pei-Yuan Lee, MD</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Show Chwan Memorial Hospital</name>
      <address>
        <city>Changhua City</city>
        <state>Changhua</state>
        <zip>500</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ming-Hsien Hu, MD</last_name>
      <phone>+886-975611289</phone>
      <email>minghsienhu@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>April 11, 2020</last_update_submitted>
  <last_update_submitted_qc>April 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Show Chwan Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Pei-Yuan Lee, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Bone Marrow</keyword>
  <keyword>Mesenchymal Stromal Cells</keyword>
  <keyword>spine fusion surgery</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT03793530
org study id: RD106050
nct id: NCT03793530
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study aims to evaluate the effect of bone marrow concentration on bone healing and
      spinal fusion by comparing clinical and imaging outcomes between patients receiving
      transforaminal lumbar intebody fusion with local bone graft and with intraoperative bone
      marrow concentration and those receiving transforaminal lumbar intebody fusion with local
      bone graft only.
Spinal arthrodesis has become the mainstay of treatment for severe spinal deformity, spinal
      instability, spondylolisthesis, and symptomatic degenerative disease. Its primary goal is to
      develop an osseous bridge between adjacent motion segments to prevent motion, relieve pain,
      and facilitate neurological recovery. One of the arthrodesis method is transforaminal lumbar
      intebody fusion. After removal of the problematic disc, iliac crest bone graft was harvested
      and impacted into the space with cage to facilitate fusion. However, patients are exposed to
      additional risk of harvesting site, such as pain, infection, wound healing problem or
      hematomas. Local bone graft harvested from decompression is one of the alternative solutions
      to avoid these complications. However, the effect of local boen graft is inferior to iliac
      crest bone graft because iliac crest bone graft contains three important ingredients for
      successful fusion: osteoconductive scaffold, osteoinductive factors, and the ability to
      osteogenesis. Mesenchymal stem cells (MSCs) are pluripotent cells that can differentiate into
      multiple mesenchymal tissues, including tenocytes, chondrocytes and osteoblasts, as well as
      being a source of multiple growth factors to establish an environment conducive to soft and
      hard tissue regeneration. As bone marrow concentration has high concentration of mesenchymal
      stem cells, some studies have shown that autologous bone marrow concentration can improve
      bone healing. In this study, we will add bone marrow concentration into local bone graft
      during transforaminal lumbar intebody fusion and evaluate the effect of bone marrow
      concentration on bone healing and spinal fusion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: 3-month postoperative spinal function evaluated by Oswestry Disability Index
time frame: 3-month postoperative
description: Subjective evaluation of spinal function by Oswestry Disability Index. Oswestry Disability Index ranges from 0 to 100 and lower score indicates less disability.
measure: 6-month postoperative spinal function evaluated by Oswestry Disability Index
time frame: 6-month postoperative
description: Subjective evaluation of spinal function by Oswestry Disability Index. Oswestry Disability Index ranges from 0 to 100 and lower score indicates less disability.
measure: 12-month postoperative spinal function evaluated by Oswestry Disability Index
time frame: 12-month postoperative
description: Subjective evaluation of spinal function by Oswestry Disability Index. Oswestry Disability Index ranges from 0 to 100 and lower score indicates less disability.
measure: 3-month postoperative degree of pain evaluated by visual analogue scale
time frame: 3-month postoperative
description: Subjective evaluation of degree of pain by visual analogue scale. Visual analogue scale for pain ranges from 0 to 10 and higher score indicates more pain.
measure: 6-month postoperative degree of pain evaluated by visual analogue scale
time frame: 6-month postoperative
description: Subjective evaluation of degree of pain by visual analogue scale. Visual analogue scale for pain ranges from 0 to 10 and higher score indicates more pain.
measure: 12-month postoperative degree of pain evaluated by visual analogue scale
time frame: 12-month postoperative
description: Subjective evaluation of degree of pain by visual analogue scale. Visual analogue scale for pain ranges from 0 to 10 and higher score indicates more pain.
measure: 3-month postoperative degree of bone healing evaluated by plain radiograph
time frame: 3-month postoperative
description: Degree of bone healing evaluated by plain radiograph
measure: 6-month postoperative degree of bone healing evaluated by plain radiograph
time frame: 6-month postoperative
description: Degree of bone healing evaluated by plain radiograph
measure: 12-month postoperative degree of bone healing evaluated by plain radiograph
time frame: 12-month postoperative
description: Degree of bone healing evaluated by plain radiograph
measure: 12-month postoperative degree of bone healing evaluated by computed tomograph
time frame: 12-month postoperative
description: Degree of bone healing evaluated by computed tomograph
arm group label: Bone marrow concentration group
arm group type: Experimental
description: Transforaminal lumbar interbody fusion with local bone graft and intraoperative bone marrow concentration
arm group label: Control group
arm group type: Active Comparator
description: Transforaminal lumbar interbody fusion with local bone graft
intervention type: Other
intervention name: Transforaminal lumbar interbody fusion with local bone graft and intraoperative bone marrow concentration
description: Transforaminal lumbar interbody fusion with local bone graft and intraoperative bone marrow concentration
arm group label: Bone marrow concentration group
intervention type: Other
intervention name: Transforaminal lumbar interbody fusion with local bone graft
description: Transforaminal lumbar interbody fusion with local bone graft
arm group label: Control group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Pei-Yuan Lee, MD
role: Study Chair
affiliation: Show Chwan Memorial Hospital
last name: Ming-Hsien Hu, MD
phone: +886-975611289
email: minghsienhu@gmail.com
last name: Pei-Yuan Lee, MD
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor-Investigator
investigator affiliation: Show Chwan Memorial Hospital
investigator full name: Pei-Yuan Lee, MD
investigator title: Principal Investigator
sharing ipd: No