<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/NCT04432389</url>
  </required_header>
  <id_info>
    <org_study_id>000013/BT</org_study_id>
    <nct_id>NCT04432389</nct_id>
  </id_info>
  <brief_title>Study to Assess the Efficacy and Safety of Allogeneic Osteoblastic Cells (ALLOB®) Single Implantation in Tibial Fracture</brief_title>
  <acronym>ALLOB-TF2</acronym>
  <official_title>Phase IIb, Placebo-Controlled, Randomized, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Allogeneic Osteoblastic Cells (ALLOB®) Single Implantation in Tibial Fracture</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bone Therapeutics S.A</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ICON plc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Bone Therapeutics S.A</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>
      Although the majority of tibial fractures heal normally, some fractures may not heal within&#xD;
      the usual time frame and is known as delayed bone healing within 4 to 6 months and absence of&#xD;
      bone healing within 9 to 12 months in the most severe case of. Several factors can increase&#xD;
      the risks of delayed healing complications like, for example, smoking, violent shocks (for&#xD;
      example, due to a road accident) or even the type of fracture (an open fracture). The&#xD;
      location of the fracture is also an important factor: among the bones of the arms and legs,&#xD;
      the tibia is known for being the most at risk for complications. At tibial fracture with&#xD;
      several risk factors could lead to delayed complications and interfere with patient daily&#xD;
      life and reduce the quality of life.&#xD;
&#xD;
      The study drug, ALLOB®, is constituted of bone cells produced from the bone marrow of healthy&#xD;
      adult donors. Preclinical studies have shown that ALLOB® cells are capable of forming bone&#xD;
      and repairing fractures. When directly injected into a fracture, ALLOB® should therefore&#xD;
      promote the healing of the fracture by re-establishing a healthy environment and stimulating&#xD;
      bone production. To date, there is no treatment for fractures considered at risk of delayed&#xD;
      complications. The current practice on diagnosis of complications is to wait at least 6-12&#xD;
      months before considering alternative interventions to promote fracture healing. The&#xD;
      injection of ALLOB® quickly after the fracture should stimulate bone healing, reduce healing&#xD;
      time, reduce complications, and improve the quality of life for the patient. ALLOB® has&#xD;
      already shown preliminary evidence of effectiveness in the treatment of delayed bone healing&#xD;
      fractures (ALLOB-DU1 clinical trial), including tibial fractures (8 patients). With this&#xD;
      study, the Sponsor will evaluate whether ALLOB® promotes the healing of tibial fractures&#xD;
      compared with placebo.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 8, 2021</start_date>
  <completion_date type="Anticipated">March 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2022</primary_completion_date>
  <phase>Phase 2</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>proportion of subjects with a radiological success at Week 12</measure>
    <time_frame>12 weeks</time_frame>
    <description>A radiological success is defined as a subject with a Radiological Union Score for Tibia (RUST) above the threshold value predictive of a normal bone healing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with radiological success at Week 16, Week 20 and Month 6</measure>
    <time_frame>16 weeks - 20 weeks - 6 months</time_frame>
    <description>A radiological success is defined as a subject with a Radiological Union Score for Tibia (RUST) above the threshold value predictive of a normal bone healing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Radiographic Union Score for Tibia (RUST) at Week 12, Week 16, Week 20 and Month 6 compared to baseline visit</measure>
    <time_frame>weeks 12 - 16 - 20 - 6 months</time_frame>
    <description>Radiological fracture healing is defined by a radiological fracture union evaluated and adjudicated by Independent Radiologists.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">178</enrollment>
  <condition>Tibial Fracture</condition>
  <arm_group>
    <arm_group_label>ALLOB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single injection of ALLOB at fracture site (4 ml)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Single injection of Placebo at fracture site (4 ml)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ALLOB</intervention_name>
    <description>After thawing, ALLOB® is a ready-to-use product for local administration at fracture site.</description>
    <arm_group_label>ALLOB</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>Placebo injected is a saline solution injectable grade (4 mL of 0.9% NaCl) filled in single-dose vial</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men and women at least 18 years of age&#xD;
&#xD;
          2. Subject diagnosed with a fresh proximal, midshaft or distal tibial fracture with&#xD;
             definitive reduction performed with nail(s) and wound closure within 1 week of&#xD;
             fracture occurrence&#xD;
&#xD;
          3. Mechanism of injury at risk of DU/NU: fracture occurring because of a high energy&#xD;
             impact&#xD;
&#xD;
          4. At increased risk of DU/NU defined by:&#xD;
&#xD;
               -  Severe open fracture (Gustilo-Anderson grade IIIa and IIIb) OR&#xD;
&#xD;
               -  Open (Gustilo-Anderson grade I-II) or closed (Tscherne grade II-III) fracture&#xD;
                  with at least one additional risk factor among smoking , comminuted fracture or&#xD;
                  cortical continuity (0-50%)&#xD;
&#xD;
          5. Ability to obtain a written, dated, and signed informed consent prior to any study&#xD;
             related procedures and ability to understand and comply with study requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Definitive reduction at the fracture site under investigation performed with plate,&#xD;
             screw or external fixator&#xD;
&#xD;
          2. Subjects who did not receive a standard antibiotic prophylaxis before definitive&#xD;
             reduction at the fracture site under investigation&#xD;
&#xD;
          3. Intra-articular tibial pilon and/or plateau fracture at the site under investigation&#xD;
&#xD;
          4. Known osteomyelitis at the fracture site under investigation&#xD;
&#xD;
          5. Bone defect post-definitive reduction greater than 1cm at least on 2 cortices at the&#xD;
             fracture site under investigation&#xD;
&#xD;
          6. Fracture requiring vascular surgery at the site under investigation&#xD;
&#xD;
          7. Pathological fractures as judged by the Investigator, such as tumor or metabolic bone&#xD;
             disease&#xD;
&#xD;
          8. Bifocal or multifocal fracture at the site under investigation&#xD;
&#xD;
          9. Presence of fever (defined as body temperature ≥ 38°C) or other signs/symptoms&#xD;
             suggestive of active infection before randomization&#xD;
&#xD;
         10. Severe brain trauma with a Glasgow Coma Scale (GCS) [3 - 8] or severe spinal cord&#xD;
             injury with impossibility of weight-bearing&#xD;
&#xD;
         11. Current or history (within 5 years) of any neoplasia (except for basal cell carcinoma&#xD;
             of the skin and for carcinoma in situ of the cervix that has been treated with no&#xD;
             evidence of recurrence)&#xD;
&#xD;
         12. Known metabolic diseases potentially interfering with bone healing as judged by the&#xD;
             Investigator, such as thyroid dysfunction, Paget disease or severe osteoporosis&#xD;
&#xD;
         13. Planned or history of solid organ transplantation or bone marrow transplantation&#xD;
&#xD;
         14. Known disease, including genetic disease, that may possibly need solid organ&#xD;
             transplantation&#xD;
&#xD;
         15. Subject with renal impairment requiring dialysis or with clinically significant renal&#xD;
             impairment defined as serum creatinine &gt;2.0 x ULN&#xD;
&#xD;
         16. Clinically significant hepatic function impairment defined as ALT/AST levels &gt; 3x ULN&#xD;
             or total bilirubin levels &gt; 2 x ULN&#xD;
&#xD;
         17. Known hematologic disease as evidenced by hematocrit &lt; 25%, white blood cell &lt;&#xD;
             2,500/ul or platelet values &lt; 100,000/ul without another explanation&#xD;
&#xD;
         18. Subject with an history of long standing poorly controlled chronic hypertension or&#xD;
             diabetes that could put him at risk of needing a kidney transplant later on according&#xD;
             to the Investigator&#xD;
&#xD;
         19. History of hypersensitivity to human biological material including blood and blood&#xD;
             derived products&#xD;
&#xD;
         20. Known allergy to DMSO, dextran, gentamicin and any other aminoglycosides&#xD;
&#xD;
         21. Participation in another interventional clinical study within 3 months prior to&#xD;
             screening&#xD;
&#xD;
         22. Any chronic intake of medication within one month that might affect bone metabolism or&#xD;
             the quality of bone formation such as but not limited to bisphosphonates,&#xD;
             teriparatide, systemic steroids, anticoagulant therapies, methotrexate and other&#xD;
             immunosuppressant drugs or related immunotherapy&#xD;
&#xD;
         23. Previous (within 10 years) treatment with bisphosphonates&#xD;
&#xD;
         24. Current treatment with bone morphogenic protein or any other osteo-biologic&#xD;
             intervention at the site of the tibial fracture&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Olivier Godeaux, MD</last_name>
    <phone>+32 (0)71 121000</phone>
    <email>clinicaltrials@bonetherapeutics.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tf2-Be-05</name>
      <address>
        <city>Anderlecht</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tf2-Be-03</name>
      <address>
        <city>Genk</city>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tf2-Be-04</name>
      <address>
        <city>Leuven</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tf2-Be-01</name>
      <address>
        <city>Lodelinsart</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tf2-Cz-05</name>
      <address>
        <city>Jindřichův Hradec</city>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tf2-Cz-03</name>
      <address>
        <city>Kladno</city>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tf2-Cz-04</name>
      <address>
        <city>Nový Jičín</city>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tf2-Cz-02</name>
      <address>
        <city>Praha</city>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tf2-Cz-06</name>
      <address>
        <city>Praha</city>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tf2-Cz-01</name>
      <address>
        <city>České Budějovice</city>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tf2-Fr-06</name>
      <address>
        <city>Amiens</city>
        <zip>80000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>study coordinator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tf2-Fr-04</name>
      <address>
        <city>Amiens</city>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tf2-Fr-01</name>
      <address>
        <city>Brest</city>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tf2-Fr-02</name>
      <address>
        <city>Chambray-lès-Tours</city>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tf2-Fr-06</name>
      <address>
        <city>Poitiers</city>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tf2-de-04</name>
      <address>
        <city>Gießen</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tf2-de-06</name>
      <address>
        <city>Luebeck</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tf2-de-02</name>
      <address>
        <city>Mannheim</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tf2-de-01</name>
      <address>
        <city>Münster</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tf2-Hu-01</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Study coordinator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tf2-Hu-06</name>
      <address>
        <city>Eger</city>
        <zip>3300</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tf2-Hu-05</name>
      <address>
        <city>Kaposvár</city>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tf2-Hu-02</name>
      <address>
        <city>Pécs</city>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tf2-Hu-04</name>
      <address>
        <city>Szolnok</city>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study coordinator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tf2-Hu-03</name>
      <address>
        <city>Székesfehérvár</city>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tf2-Pl-12</name>
      <address>
        <city>Kielce</city>
        <country>Poland</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tf2-Pl-08</name>
      <address>
        <city>Kraków</city>
        <country>Poland</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tf2-Pl-01</name>
      <address>
        <city>Szczecin</city>
        <country>Poland</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ft2-Pl-07</name>
      <address>
        <city>Warszawa</city>
        <country>Poland</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tf2-Pl-06</name>
      <address>
        <city>Warszawa</city>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study coordinator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tf2-Pl-02</name>
      <address>
        <city>Łódź</city>
        <country>Poland</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tf2-Es-09</name>
      <address>
        <city>Badalona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tf2-Es-08</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tf2-Es-02</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tf2-Es-03</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tf2-Es-07</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tf2-Es-06</name>
      <address>
        <city>Málaga</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tf2-Es-05</name>
      <address>
        <city>Pontevedra</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tf2-Es-01</name>
      <address>
        <city>Terrassa</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Poland</country>
    <country>Spain</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 4, 2021</last_update_submitted>
  <last_update_submitted_qc>June 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2021</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>Fractures, Bone</mesh_term>
    <mesh_term>Tibial Fractures</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/NCT04432389
org study id: 000013/BT
nct id: NCT04432389
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Although the majority of tibial fractures heal normally, some fractures may not heal within
      the usual time frame and is known as delayed bone healing within 4 to 6 months and absence of
      bone healing within 9 to 12 months in the most severe case of. Several factors can increase
      the risks of delayed healing complications like, for example, smoking, violent shocks (for
      example, due to a road accident) or even the type of fracture (an open fracture). The
      location of the fracture is also an important factor: among the bones of the arms and legs,
      the tibia is known for being the most at risk for complications. At tibial fracture with
      several risk factors could lead to delayed complications and interfere with patient daily
      life and reduce the quality of life.

      The study drug, ALLOB®, is constituted of bone cells produced from the bone marrow of healthy
      adult donors. Preclinical studies have shown that ALLOB® cells are capable of forming bone
      and repairing fractures. When directly injected into a fracture, ALLOB® should therefore
      promote the healing of the fracture by re-establishing a healthy environment and stimulating
      bone production. To date, there is no treatment for fractures considered at risk of delayed
      complications. The current practice on diagnosis of complications is to wait at least 6-12
      months before considering alternative interventions to promote fracture healing. The
      injection of ALLOB® quickly after the fracture should stimulate bone healing, reduce healing
      time, reduce complications, and improve the quality of life for the patient. ALLOB® has
      already shown preliminary evidence of effectiveness in the treatment of delayed bone healing
      fractures (ALLOB-DU1 clinical trial), including tibial fractures (8 patients). With this
      study, the Sponsor will evaluate whether ALLOB® promotes the healing of tibial fractures
      compared with placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: proportion of subjects with a radiological success at Week 12
time frame: 12 weeks
description: A radiological success is defined as a subject with a Radiological Union Score for Tibia (RUST) above the threshold value predictive of a normal bone healing.
measure: Proportion of subjects with radiological success at Week 16, Week 20 and Month 6
time frame: 16 weeks - 20 weeks - 6 months
description: A radiological success is defined as a subject with a Radiological Union Score for Tibia (RUST) above the threshold value predictive of a normal bone healing.
measure: Change in Radiographic Union Score for Tibia (RUST) at Week 12, Week 16, Week 20 and Month 6 compared to baseline visit
time frame: weeks 12 - 16 - 20 - 6 months
description: Radiological fracture healing is defined by a radiological fracture union evaluated and adjudicated by Independent Radiologists.
arm group label: ALLOB
arm group type: Experimental
description: Single injection of ALLOB at fracture site (4 ml)
arm group label: placebo
arm group type: Placebo Comparator
description: Single injection of Placebo at fracture site (4 ml)
intervention type: Biological
intervention name: ALLOB
description: After thawing, ALLOB® is a ready-to-use product for local administration at fracture site.
arm group label: ALLOB
intervention type: Other
intervention name: placebo
description: Placebo injected is a saline solution injectable grade (4 mL of 0.9% NaCl) filled in single-dose vial
arm group label: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Olivier Godeaux, MD
phone: +32 (0)71 121000
email: clinicaltrials@bonetherapeutics.com
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country: Belgium
country: Czechia
country: France
country: Germany
country: Hungary
country: Poland
country: Spain
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Tibial Fractures