<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/NCT03810573</url>
  </required_header>
  <id_info>
    <org_study_id>NB1-100</org_study_id>
    <nct_id>NCT03810573</nct_id>
  </id_info>
  <brief_title>Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis</brief_title>
  <official_title>A Multi-Center, Prospective, Parallel Group, Randomized, Pilot Study Evaluating Safety And Preliminary Effectiveness Of NB1 Bone Graft In Subjects With Degenerative Disc Disease Undergoing Transforaminal Lumbar Interbody Fusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bone Biologics Corp</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bone Biologics Corp</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this clinical study is to evaluate the safety and effectiveness of NB1 Bone&#xD;
      Graft in subjects with degenerative disc disease undergoing transforaminal lumbar interbody&#xD;
      fusion.&#xD;
&#xD;
      It is estimated that up to 30 participants will be enrolled in approximately 3 clinical&#xD;
      sites. During baseline and follow-up assessments, patients will be asked to undergo x-rays&#xD;
      and CT scans; adverse events and immunology will be collected, and; participants will be&#xD;
      requested to complete participant questionnaires regarding quality of life, pain and&#xD;
      function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">March 2023</start_date>
  <completion_date type="Anticipated">April 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2024</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>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fusion</measure>
    <time_frame>12 months</time_frame>
    <description>Defined by an independent (blinded to treatment) radiological assessment as less than five degrees angular vertebral motion, less than three millimeters of translational movement and evidence of bridging bone between the involved vertebral endplates based on x-rays at 12 months after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Removal, revision, or supplemental fixation</measure>
    <time_frame>12 months</time_frame>
    <description>Whether there was removal, revision or supplemental fixation of the graft material that required reoperation at the index level during the follow-up period of the study</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Degenerative Disc Disease</condition>
  <condition>Spondylolisthesis</condition>
  <arm_group>
    <arm_group_label>NB1-1.5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NB1 low dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NB1-2.0</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NB1 high dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Autograft</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Autograft</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NB1</intervention_name>
    <description>rhNELL-1/DBX</description>
    <arm_group_label>NB1-1.5</arm_group_label>
    <arm_group_label>NB1-2.0</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Documented diagnosis of degenerative disc disease&#xD;
&#xD;
          -  Up to Grade I spondylolisthesis&#xD;
&#xD;
          -  Eligible to undergo a single vertebral level spine fusion (L2 to S1)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous spinal instrumentation or previous interbody fusion procedure at the involved&#xD;
             level&#xD;
&#xD;
          -  Grade II or greater spondylolisthesis&#xD;
&#xD;
          -  Systemic or local infection at the site of surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tony Goldschlager, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Monash Health</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Brent Atkinson, PhD</last_name>
    <phone>13035507866</phone>
    <email>atkinsonbrent520@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Monash Medical Center</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
    <contact>
      <last_name>Tony Goldschlager, MD</last_name>
    </contact>
    <investigator>
      <last_name>Tony Goldschlager, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>March 2, 2022</last_update_submitted>
  <last_update_submitted_qc>March 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intervertebral Disc Degeneration</mesh_term>
    <mesh_term>Spondylolisthesis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>As requested</ipd_description>
  </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/NCT03810573
org study id: NB1-100
nct id: NCT03810573
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
The objective of this clinical study is to evaluate the safety and effectiveness of NB1 Bone
      Graft in subjects with degenerative disc disease undergoing transforaminal lumbar interbody
      fusion.

      It is estimated that up to 30 participants will be enrolled in approximately 3 clinical
      sites. During baseline and follow-up assessments, patients will be asked to undergo x-rays
      and CT scans; adverse events and immunology will be collected, and; participants will be
      requested to complete participant questionnaires regarding quality of life, pain and
      function.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Fusion
time frame: 12 months
description: Defined by an independent (blinded to treatment) radiological assessment as less than five degrees angular vertebral motion, less than three millimeters of translational movement and evidence of bridging bone between the involved vertebral endplates based on x-rays at 12 months after surgery
measure: Removal, revision, or supplemental fixation
time frame: 12 months
description: Whether there was removal, revision or supplemental fixation of the graft material that required reoperation at the index level during the follow-up period of the study
arm group label: NB1-1.5
arm group type: Experimental
description: NB1 low dose
arm group label: NB1-2.0
arm group type: Experimental
description: NB1 high dose
arm group label: Autograft
arm group type: No Intervention
description: Autograft
intervention type: Device
intervention name: NB1
description: rhNELL-1/DBX
arm group label: NB1-1.5
arm group label: NB1-2.0
criteria: 
gender: All
minimum age: 17 Years
maximum age: 70 Years
healthy volunteers: No
last name: Tony Goldschlager, MD
role: Principal Investigator
affiliation: Monash Health
last name: Brent Atkinson, PhD
phone: 13035507866
email: atkinsonbrent520@gmail.com
facility: 
contact: 
investigator: 
country: Australia
responsible party type: Sponsor
mesh term: Intervertebral Disc Degeneration
mesh term: Spondylolisthesis
sharing ipd: Undecided
ipd description: As requested