<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/NCT02205138</url>
  </required_header>
  <id_info>
    <org_study_id>ALLOB-IF1</org_study_id>
    <nct_id>NCT02205138</nct_id>
  </id_info>
  <brief_title>Phase 2a Study on Allogeneic Osteoblastic Cells Implantation in Lumbar Spinal Fusion</brief_title>
  <official_title>A Pilot Phase 2a, Multicentre, Open, Proof-of-concept Study on the Safety and the Efficacy of Allogeneic Osteoblastic Cells (ALLOB®) Implantation in Lumbar Spinal Fusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bone Therapeutics S.A</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bone Therapeutics S.A</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Among existing surgical techniques, spinal fusion is considered as the gold standard to treat&#xD;
      a broad spectrum of degenerative spine disorders, including spondylolisthesis and scoliosis,&#xD;
      with regard to pain reduction and functional improvement. However, pseudarthrosis and failure&#xD;
      to relieve low back pain are unfortunately still frequent, irrespective of the type of&#xD;
      procedures and grafts used by the surgeon.&#xD;
&#xD;
      The present Phase 2a study aims at demonstrating the safety and efficacy of ALLOB®, a&#xD;
      proprietary population of allogeneic osteoblastic cells, in lumbar spinal fusion.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">January 25, 2021</completion_date>
  <primary_completion_date type="Actual">February 2019</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>Lumbar fusion progression as assessed by CT scan</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional Disability using Oswestry Disability Index</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Potential occurrence of any AE or SAE, related to the product or to the procedure, using patient open non-directive questionnaire, physical examination and laboratory measurements</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain using a Visual Analogue Scale</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Disease Evaluation using a Visual Analogue Scale</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Disability using Oswestry Disability Index</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lumbar fusion progression as assessed by CT scan</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients having a rescue surgery</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potential occurrence of any AE or SAE related to the product or to the procedure</measure>
    <time_frame>36 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Degenerative Disc Disease</condition>
  <arm_group>
    <arm_group_label>ALLOB® cells with ceramic scaffold</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ALLOB® cells with ceramic scaffold Implantation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ALLOB® cells with ceramic scaffold</intervention_name>
    <description>Each patient will undergo a single administration of ALLOB®/ceramic scaffold mix into the lumbar interbody fusion site under anaesthesia</description>
    <arm_group_label>ALLOB® cells with ceramic scaffold</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability to provide a written, dated, and signed informed consent prior to any study&#xD;
             related procedure, and to understand and comply with study requirements&#xD;
&#xD;
          -  Symptomatic degenerative disc disease of the lumbar spine requiring a single level&#xD;
             lumbar fusion (L1-S1)&#xD;
&#xD;
          -  Unresponsive to non-operative treatment for at least 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lumbar disc disease requiring treatment at more than one level&#xD;
&#xD;
          -  Previous failed fusion at the involved lumbar level&#xD;
&#xD;
          -  Local active or latent infection at the involved lumbar level&#xD;
&#xD;
          -  Positive serology for hepatitis B, hepatitis C, HIV&#xD;
&#xD;
          -  Current or past medical disease that could interfere with the evaluation of the safety&#xD;
             and efficacy, as judged by the investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Investigating site BE01</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigating site BE03</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigating site BE05</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigating site BE02</name>
      <address>
        <city>Charleroi</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigating site BE04</name>
      <address>
        <city>Genk</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigating site BE08</name>
      <address>
        <city>Kortrijk</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigating site BE07</name>
      <address>
        <city>Liège</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigating site BE06</name>
      <address>
        <city>Mons</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>January 28, 2021</last_update_submitted>
  <last_update_submitted_qc>January 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Spinal Fusion</keyword>
  <keyword>Lumbar Interbody Fusion</keyword>
  <keyword>Degenerative Disc Disease</keyword>
  <keyword>Cell Therapy</keyword>
  <keyword>Bone Graft</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intervertebral Disc Degeneration</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/NCT02205138
org study id: ALLOB-IF1
nct id: NCT02205138
lead sponsor: 
has dmc: No
Among existing surgical techniques, spinal fusion is considered as the gold standard to treat
      a broad spectrum of degenerative spine disorders, including spondylolisthesis and scoliosis,
      with regard to pain reduction and functional improvement. However, pseudarthrosis and failure
      to relieve low back pain are unfortunately still frequent, irrespective of the type of
      procedures and grafts used by the surgeon.

      The present Phase 2a study aims at demonstrating the safety and efficacy of ALLOB®, a
      proprietary population of allogeneic osteoblastic cells, in lumbar spinal fusion.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Lumbar fusion progression as assessed by CT scan
time frame: 12 months
measure: Functional Disability using Oswestry Disability Index
time frame: 12 months
measure: Potential occurrence of any AE or SAE, related to the product or to the procedure, using patient open non-directive questionnaire, physical examination and laboratory measurements
time frame: 12 months
measure: Pain using a Visual Analogue Scale
time frame: 12 months
measure: Global Disease Evaluation using a Visual Analogue Scale
time frame: 12 months
measure: Functional Disability using Oswestry Disability Index
time frame: 12 months
measure: Lumbar fusion progression as assessed by CT scan
time frame: 12 months
measure: Percentage of patients having a rescue surgery
time frame: 12 months
measure: Potential occurrence of any AE or SAE related to the product or to the procedure
time frame: 36 months
arm group label: ALLOB® cells with ceramic scaffold
arm group type: Experimental
description: ALLOB® cells with ceramic scaffold Implantation
intervention type: Drug
intervention name: ALLOB® cells with ceramic scaffold
description: Each patient will undergo a single administration of ALLOB®/ceramic scaffold mix into the lumbar interbody fusion site under anaesthesia
arm group label: ALLOB® cells with ceramic scaffold
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Intervertebral Disc Degeneration