<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/NCT01700920</url>
  </required_header>
  <id_info>
    <org_study_id>CSM/ON/2011</org_study_id>
    <nct_id>NCT01700920</nct_id>
  </id_info>
  <brief_title>PHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells</brief_title>
  <acronym>CSM/ON/2011</acronym>
  <official_title>PHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Red de Terapia Celular</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Spanish National Health System</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Red de Terapia Celular</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to analyze the safety and feasibility of direct administration&#xD;
      intrafemoral mesenchymal stem cells (MSCs) in vitro expanded autologous treatment of patients&#xD;
      with femoral osteonecrosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Osteonecrosis of the Femoral Head</condition>
  <arm_group>
    <arm_group_label>Mesenchymal Stem Cell</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cell suspension mesenchymal stem cells (MSCs) obtained from bone marrow aspirate from the patient and expanded in vitro in a specific medium enriched with platelet lysate without addition of animal products.&#xD;
They employ a minimum dose of 0.5 x 106 MSC / kg and a maximum of 1, 0x106 CSM / kg of patient weight.&#xD;
Pharmaceutical form: Suspension cell Route of administration: local implant intraosseous injection with trocar in the femoral head.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>bone marrow aspirate</intervention_name>
    <arm_group_label>Mesenchymal Stem Cell</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18 and 70 years&#xD;
&#xD;
          -  Clinical diagnosis and imaging (Rx and NMR) of idiopathic osteonecrosis of the femoral&#xD;
             head&#xD;
&#xD;
          -  Stadiums &lt;IIIC ARCO ranking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those on investigator judgment not in a good position to tolerate the procedure.&#xD;
&#xD;
          -  Clinical criteria and anesthetics that contraindicate surgery (eg ASA IV-V)&#xD;
&#xD;
          -  Serious illness uncontrolled&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Patients with HIV infection +&#xD;
&#xD;
          -  Acute infection (in the previous 15 days) or chronic (other than HIV)&#xD;
&#xD;
          -  Previous treatments of osteonecrosis&#xD;
&#xD;
          -  Active or previous neoplastic disease (last 5 years) except for patients undergoing&#xD;
             allogeneic haematopoietic progenitors who are in complete remission after 2 years&#xD;
             after transplantation.&#xD;
&#xD;
          -  Lack of informed consent or revocation thereof.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospital of Salamanca</name>
      <address>
        <city>Salamanca</city>
        <state>Castilla y León</state>
        <zip>37007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://www.red-tercel.com</url>
    <description>Spanish cell therapy network (TerCel)</description>
  </link>
  <link>
    <url>http://fundacion.usal.es</url>
    <description>Salamanca University Foundation</description>
  </link>
  <link>
    <url>http://www.isciii.es</url>
    <description>Spanish Health Institute Carlos III</description>
  </link>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>March 29, 2017</last_update_submitted>
  <last_update_submitted_qc>March 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Osteonecrosis of the femoral head</keyword>
  <keyword>Stem Cell</keyword>
  <keyword>Mesenchymal Stem Cells</keyword>
  <keyword>Femoral Head</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteonecrosis</mesh_term>
    <mesh_term>Legg-Calve-Perthes Disease</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/NCT01700920
org study id: CSM/ON/2011
nct id: NCT01700920
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to analyze the safety and feasibility of direct administration
      intrafemoral mesenchymal stem cells (MSCs) in vitro expanded autologous treatment of patients
      with femoral osteonecrosis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
arm group label: Mesenchymal Stem Cell
arm group type: Experimental
description: Cell suspension mesenchymal stem cells (MSCs) obtained from bone marrow aspirate from the patient and expanded in vitro in a specific medium enriched with platelet lysate without addition of animal products.
They employ a minimum dose of 0.5 x 106 MSC / kg and a maximum of 1, 0x106 CSM / kg of patient weight.
Pharmaceutical form: Suspension cell Route of administration: local implant intraosseous injection with trocar in the femoral head.
intervention type: Procedure
intervention name: bone marrow aspirate
arm group label: Mesenchymal Stem Cell
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Spain
url: http://www.red-tercel.com
description: Spanish cell therapy network (TerCel)
url: http://fundacion.usal.es
description: Salamanca University Foundation
url: http://www.isciii.es
description: Spanish Health Institute Carlos III
responsible party type: Sponsor
mesh term: Osteonecrosis
mesh term: Legg-Calve-Perthes Disease