<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/NCT02230514</url>
  </required_header>
  <id_info>
    <org_study_id>XCEL-PSART-01</org_study_id>
    <secondary_id>2013-005025-23</secondary_id>
    <nct_id>NCT02230514</nct_id>
  </id_info>
  <brief_title>Mesenchymal Stromal Cells for the Treatment of Non-union Fractures of Long Bones</brief_title>
  <official_title>A Phase IIa, Single Center, Prospective, Randomized, Parallel, Two-arms, Single-dose, Open-label With Blinded Assessor Pilot Clinical Trial to Assess ex Vivo Expanded Adult Autologous Mesenchymal Stromal Cells Fixed in Allogeneic Bone Tissue (XCEL-MT-OSTEO-ALPHA) in Non Hypertrophic Pseudoarthrosis of Long Bones</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Banc de Sang i Teixits</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital ASEPEYO Sant Cugat</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Banc de Sang i Teixits</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present study evaluates the effect of XCEL-MT-OSTEO-ALPHA in non-union fractures&#xD;
      (pseudoarthrosis) of long bones in comparison to the standard treatment of autologous iliac&#xD;
      crest.&#xD;
&#xD;
      XCEL-MT-OSTEO-ALPHA is a tissue engineering product composed by &quot;ex-vivo&quot; expanded autologous&#xD;
      mesenchymal stromal cells fixed in allogenic bone tissue, produced by Xcelia (Blood and&#xD;
      Tissue Bank of Catalonia).&#xD;
&#xD;
      The working hypothesis proposes that the tissue engineering is a valid and useful technique&#xD;
      to achieve bone regeneration up to consolidation of non-union fractures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A phase IIa, single center, prospective, randomized, parallel, two-arms, single-dose,&#xD;
      open-label with blinded assessor pilot clinical trial to assess ex vivo expanded adult&#xD;
      autologous mesenchymal stromal cells fixed in allogeneic bone tissue (XCEL-MT-OSTEO-ALPHA) in&#xD;
      non hypertrophic pseudoarthrosis of long bones.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 20, 2014</start_date>
  <completion_date type="Actual">December 20, 2019</completion_date>
  <primary_completion_date type="Actual">March 5, 2019</primary_completion_date>
  <phase>Phase 1/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>Single (Outcomes Assessor)</masking>
    <masking_description>Radiologist will assess images in a blinded manner</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures by imaging procedures</measure>
    <time_frame>12 month</time_frame>
    <description>Hounsfield units quantification by tomography in both treatment arms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures</measure>
    <time_frame>12 month</time_frame>
    <description>Safety will be assessed by collecting adverse events throughout the experimental phase which includes a follow-up of 12 month.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures by imaging procedures</measure>
    <time_frame>6 month</time_frame>
    <description>Characteristics of the callus by tomography and Characteristics of the callus by standard x-ray in both treatment arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy assessment by quality of life test</measure>
    <time_frame>12 month</time_frame>
    <description>Quality of life will be measured by EUROQOL-5D test</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Atrophic Nonunion of Fracture</condition>
  <arm_group>
    <arm_group_label>XCEL-MT-OSTEO-ALPHA and surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>&quot;ex-vivo&quot; expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Autologous iliac crest and surgery</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Standard treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>XCEL-MT-OSTEO-ALPHA</intervention_name>
    <description>&quot;ex-vivo&quot; expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue in association with open surgery</description>
    <arm_group_label>XCEL-MT-OSTEO-ALPHA and surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>autologous iliac crest</intervention_name>
    <description>Autologous iliac crest in association with surgery</description>
    <arm_group_label>Autologous iliac crest and surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgery</intervention_name>
    <description>Standard surgery for non-union fractures</description>
    <arm_group_label>Autologous iliac crest and surgery</arm_group_label>
    <arm_group_label>XCEL-MT-OSTEO-ALPHA and surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 to 85 years of age (male and female)&#xD;
&#xD;
          -  Atrophic or hypotrophic metaphyseal-diaphyseal pseudarthrosis of long bones, confirmed&#xD;
             radiographically.&#xD;
&#xD;
          -  Signed Informed Consent Form&#xD;
&#xD;
          -  The patient is able to understand the nature of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suspicious of pseudarthrosis focus infection diagnosed by clinical inspection and&#xD;
             blood analysis.&#xD;
&#xD;
          -  Positive serology for HIV (Anti-HIV I/II-Ac), Hepatitis B (HBsAg, HBcAc), Hepatitis C&#xD;
             (Anti-HCV-Ac) or Syphilis Lúes (TP-Ac).&#xD;
&#xD;
          -  Significant abnormal laboratory tests that contraindicates patient's participation in&#xD;
             the study.&#xD;
&#xD;
          -  Pregnant woman or without proper anticonceptive measures according to the&#xD;
             investigator, or breath feeding&#xD;
&#xD;
          -  Smoker of more than 15 cigarettes a day&#xD;
&#xD;
          -  Congenital disorders of bones (hypophosphatemia), bone metabolic disorders associated&#xD;
             to primary or secondary hypoparathyroidism.&#xD;
&#xD;
          -  Badly managed diabetes mellitus.&#xD;
&#xD;
          -  Patients diagnosed with peripheral arterial disorders&#xD;
&#xD;
          -  Previous therapeutic radiation (5 previous years) of the affected bone.&#xD;
&#xD;
          -  Neoplasia within the previous 5 years, or without remission&#xD;
&#xD;
          -  The patient is legally dependent&#xD;
&#xD;
          -  Participation in another clinical trial or treated with an investigational medicinal&#xD;
             product the previous 30 days&#xD;
&#xD;
          -  Other pathologic conditions or circumstances that difficult participation in the study&#xD;
             according to medical criteria&#xD;
&#xD;
          -  The patient does not accept to be followed-up for a period that could exceed the&#xD;
             clinical trial length&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fernando Granell, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital ASEPEYO Sant Cugat</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital ASEPEYO Sant Cugat</name>
      <address>
        <city>Sant Cugat</city>
        <state>Barcelona</state>
        <zip>08174</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://www.bancsang.net/</url>
    <description>Banc de Sang i Teixits (Blood and Tissue Bank of Catalonia)</description>
  </link>
  <link>
    <url>http://www.asepeyo.es/hospital-sant-cugat</url>
    <description>Hospital ASEPEYO Sant Cugat</description>
  </link>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>April 7, 2021</last_update_submitted>
  <last_update_submitted_qc>April 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nonunion fracture</keyword>
  <keyword>Long bones</keyword>
  <keyword>Pseudoarthrosis</keyword>
  <keyword>Cell therapy</keyword>
  <keyword>Tissue engineering</keyword>
  <keyword>Mesenchymal stromal cells</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Fractures, Ununited</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/NCT02230514
org study id: XCEL-PSART-01
secondary id: 2013-005025-23
nct id: NCT02230514
lead sponsor: 
collaborator: 
has dmc: No
The present study evaluates the effect of XCEL-MT-OSTEO-ALPHA in non-union fractures
      (pseudoarthrosis) of long bones in comparison to the standard treatment of autologous iliac
      crest.

      XCEL-MT-OSTEO-ALPHA is a tissue engineering product composed by "ex-vivo" expanded autologous
      mesenchymal stromal cells fixed in allogenic bone tissue, produced by Xcelia (Blood and
      Tissue Bank of Catalonia).

      The working hypothesis proposes that the tissue engineering is a valid and useful technique
      to achieve bone regeneration up to consolidation of non-union fractures.
A phase IIa, single center, prospective, randomized, parallel, two-arms, single-dose,
      open-label with blinded assessor pilot clinical trial to assess ex vivo expanded adult
      autologous mesenchymal stromal cells fixed in allogeneic bone tissue (XCEL-MT-OSTEO-ALPHA) in
      non hypertrophic pseudoarthrosis of long bones.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Radiologist will assess images in a blinded manner
measure: Efficacy assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures by imaging procedures
time frame: 12 month
description: Hounsfield units quantification by tomography in both treatment arms
measure: Safety assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures
time frame: 12 month
description: Safety will be assessed by collecting adverse events throughout the experimental phase which includes a follow-up of 12 month.
measure: Efficacy assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures by imaging procedures
time frame: 6 month
description: Characteristics of the callus by tomography and Characteristics of the callus by standard x-ray in both treatment arms
measure: Efficacy assessment by quality of life test
time frame: 12 month
description: Quality of life will be measured by EUROQOL-5D test
arm group label: XCEL-MT-OSTEO-ALPHA and surgery
arm group type: Experimental
description: "ex-vivo" expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue
arm group label: Autologous iliac crest and surgery
arm group type: Other
description: Standard treatment
intervention type: Drug
intervention name: XCEL-MT-OSTEO-ALPHA
description: "ex-vivo" expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue in association with open surgery
arm group label: XCEL-MT-OSTEO-ALPHA and surgery
intervention type: Other
intervention name: autologous iliac crest
description: Autologous iliac crest in association with surgery
arm group label: Autologous iliac crest and surgery
intervention type: Procedure
intervention name: Surgery
description: Standard surgery for non-union fractures
arm group label: Autologous iliac crest and surgery
arm group label: XCEL-MT-OSTEO-ALPHA and surgery
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Fernando Granell, MD, PhD
role: Principal Investigator
affiliation: Hospital ASEPEYO Sant Cugat
facility: 
country: Spain
url: http://www.bancsang.net/
description: Banc de Sang i Teixits (Blood and Tissue Bank of Catalonia)
url: http://www.asepeyo.es/hospital-sant-cugat
description: Hospital ASEPEYO Sant Cugat
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Fractures, Ununited