<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/NCT02209311</url>
  </required_header>
  <id_info>
    <org_study_id>RU-CCH-06-01-14</org_study_id>
    <nct_id>NCT02209311</nct_id>
  </id_info>
  <brief_title>Effectiveness and Safety of Method of Maxilla Alveolar Process Reconstruction Using Synthetic Tricalcium Phosphate and Autologous MMSCs</brief_title>
  <official_title>Effectiveness and Safety of Method of Maxilla Alveolar Process Reconstruction Using Tissue Engineered Construction Based on a Synthetic Tricalcium Phosphate and Autologous Multipotent Mesenchymal Stromal Cells Obtained From Oral Mucosa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Autologous MMSCs will be isolated from oral mucosa biopsy sample and expanded in vitro.Tissue&#xD;
      engineered construction will be created using synthetic tricalcium phosphate and autologous&#xD;
      MMSCs. Patients will undergo sinus lift procedure with implantation of created&#xD;
      tissue-engineered construction. This is a single arm study with no control. All patients&#xD;
      receive cell therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with verified diagnosis partially edentulous maxilla and alveolar bone atrophy will&#xD;
      undergo oral mucosa biopsy and autologous MMSCs will be derived and expanded in vitro during&#xD;
      3-4 weeks. After that tissue engineered construction will be created using synthetic&#xD;
      tricalcium phosphate and autologous MMSCs. Patients will undergo sinus lift procedure with&#xD;
      implantation of created tissue-engineered construction. Six months later patients will&#xD;
      undergo dental implant installation. Biopsy of bone tissue at the site of sinus lift will be&#xD;
      performed as a part of dental implant installation with subsequent histological analysis of&#xD;
      bone specimen.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">March 2018</completion_date>
  <primary_completion_date type="Anticipated">October 2017</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>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>Number of serious adverse events (SAEs) and serious adverse reactions (SARs)</measure>
    <time_frame>1 week after treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life monitoring</measure>
    <time_frame>up to 24 weeks after treatment</time_frame>
    <description>Quality of life estimated by validated questionnaire: the Short Form (36) Health Survey (SF-36).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in bone tissue volume</measure>
    <time_frame>up to 24 weeks after treatment</time_frame>
    <description>Changes in volume and density of bone tissue at the site of manipulation and newly formed bone micro-architecture assessed by cone beam CT (morphometrical analysis using Hounsfield unit measurements)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of morphometrical analysis using cone beam CT scan with absolute value of the newly formed bone</measure>
    <time_frame>24 weeks after treatment</time_frame>
    <description>Biopsy of bone tissue at the site of sinus lift will be performed as a part of dental implant installation. Bone sample will be evaluated histologically: absolute value of the newly formed bone will be calculated using histomorphometrical analysis.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Partially Edentulous Maxilla</condition>
  <condition>Alveolar Bone Atrophy</condition>
  <condition>Alveolar Bone Loss</condition>
  <arm_group>
    <arm_group_label>Tissue engineered construction implantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Oral mucosa biopsy</intervention_name>
    <arm_group_label>Tissue engineered construction implantation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sinus lift with implantation of tissue engineered construction</intervention_name>
    <arm_group_label>Tissue engineered construction implantation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dental implant</intervention_name>
    <arm_group_label>Tissue engineered construction implantation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Partially edentulous maxilla&#xD;
&#xD;
          -  Height of the bone tissue in the area of reconstruction 1 - 5 mm according to results&#xD;
             of cone-beam computed tomography&#xD;
&#xD;
          -  Minimal height of the augmentation - 8 mm&#xD;
&#xD;
          -  Volume of bone tissue deficiency of the alveolar process of the maxilla 3 - 5 cm3&#xD;
&#xD;
          -  Implant installation scheduled to be at least 6 months after sinus-lift operation&#xD;
&#xD;
          -  Patient is familiar with Participant information sheet&#xD;
&#xD;
          -  Patient signed informed consent form&#xD;
&#xD;
        Non-inclusion Criteria:&#xD;
&#xD;
          -  Chronic and acute ear, nose and throat diseases, including maxillary sinusitis,&#xD;
             foreign bodies in the maxillary sinus, odontogenic and not odontogenic maxillary sinus&#xD;
             cyst&#xD;
&#xD;
          -  Medical history of surgery on maxillary sinuses during preceding 6 months prior to&#xD;
             implantation of tissue engineered construction&#xD;
&#xD;
          -  Progressive somatic disease (clinically significant diseases of the cardiovascular,&#xD;
             hematopoietic or endocrine system, systemic diseases, immunopathological states)&#xD;
&#xD;
          -  Patients with malignant tumors including postoperative period, patients receiving&#xD;
             chemotherapy and/or radiotherapy&#xD;
&#xD;
          -  Any conditions limiting compliance (dementia, neuropsychiatric disease, drug and&#xD;
             alcohol abuse etc.)&#xD;
&#xD;
          -  Significant weight loss (&gt; 10% of body weight in the previous year) of unknown&#xD;
             etiology&#xD;
&#xD;
          -  Patient prescribed for any medications with proven effect on bone metabolism&#xD;
&#xD;
          -  Diabetes mellitus, disorders of thyroid and parathyroid glands&#xD;
&#xD;
          -  Clinically significant abnormalities in results of laboratory tests&#xD;
&#xD;
          -  Participation in other clinical trials (or administration of investigational drugs)&#xD;
             during 3 months prior inclusion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient's refusal from the further participation in trial&#xD;
&#xD;
          -  Patient's refusal from compliance with the requirements of contraception during the&#xD;
             participation in research&#xD;
&#xD;
          -  Plaque index (PI)&gt; 15%&#xD;
&#xD;
          -  Sulcus bleeding index (SBI) &gt; 10%&#xD;
&#xD;
          -  Chronic kidney disease IV - V stages (creatinine clearance &lt; 30 mL/min estimated by&#xD;
             Cockroft-Gault formula)&#xD;
&#xD;
          -  Confirmed syphilis, HIV, hepatitis B or C infections&#xD;
&#xD;
        Dropout Criteria:&#xD;
&#xD;
          -  Perforation of the Schneider's membrane more than 5 mm on the stage of the sinus-lift&#xD;
             operation&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Grigory Volozhin A Volozhin, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>A.I. Evdokimov Moscow State Medical Stomatological University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ilya I Eremin, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal State Budgetary Institution &quot;Central Clinical Hospital with Outpatient Health Center&quot; of the Business Administration for the President of the Russian Federation; Center for Biomedical Technologies</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Federal State Budgetary Institution &quot;Central Clinical Hospital with Outpatient Health Center&quot; of the Business Administration for the President of the Russian Federation; Center for Biomedical Technologies</name>
      <address>
        <city>Moscow</city>
        <zip>121359</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.I. Evdokimov Moscow State Medical Stomatological University</name>
      <address>
        <city>Moscow</city>
        <zip>127473</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>November 29, 2016</last_update_submitted>
  <last_update_submitted_qc>November 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alveolar Bone Loss</keyword>
  <keyword>Alveolar Bone Atrophy</keyword>
  <keyword>Dental Implantation</keyword>
  <keyword>Bone Tissue Reconstruction</keyword>
  <keyword>Sinus Lift</keyword>
  <keyword>Autologous Multipotent Mesenchymal Stem Cell</keyword>
  <keyword>Autologous MMSCs</keyword>
  <keyword>Synthetic Tricalcium Phosphate</keyword>
  <keyword>Tissue Engineered Construction</keyword>
  <keyword>Oral Mucosa</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alveolar Bone Loss</mesh_term>
    <mesh_term>Atrophy</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/NCT02209311
org study id: RU-CCH-06-01-14
nct id: NCT02209311
lead sponsor: 
has dmc: No
Autologous MMSCs will be isolated from oral mucosa biopsy sample and expanded in vitro.Tissue
      engineered construction will be created using synthetic tricalcium phosphate and autologous
      MMSCs. Patients will undergo sinus lift procedure with implantation of created
      tissue-engineered construction. This is a single arm study with no control. All patients
      receive cell therapy.
Patients with verified diagnosis partially edentulous maxilla and alveolar bone atrophy will
      undergo oral mucosa biopsy and autologous MMSCs will be derived and expanded in vitro during
      3-4 weeks. After that tissue engineered construction will be created using synthetic
      tricalcium phosphate and autologous MMSCs. Patients will undergo sinus lift procedure with
      implantation of created tissue-engineered construction. Six months later patients will
      undergo dental implant installation. Biopsy of bone tissue at the site of sinus lift will be
      performed as a part of dental implant installation with subsequent histological analysis of
      bone specimen.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of serious adverse events (SAEs) and serious adverse reactions (SARs)
time frame: 1 week after treatment
measure: Quality of life monitoring
time frame: up to 24 weeks after treatment
description: Quality of life estimated by validated questionnaire: the Short Form (36) Health Survey (SF-36).
measure: Changes in bone tissue volume
time frame: up to 24 weeks after treatment
description: Changes in volume and density of bone tissue at the site of manipulation and newly formed bone micro-architecture assessed by cone beam CT (morphometrical analysis using Hounsfield unit measurements)
measure: Correlation of morphometrical analysis using cone beam CT scan with absolute value of the newly formed bone
time frame: 24 weeks after treatment
description: Biopsy of bone tissue at the site of sinus lift will be performed as a part of dental implant installation. Bone sample will be evaluated histologically: absolute value of the newly formed bone will be calculated using histomorphometrical analysis.
arm group label: Tissue engineered construction implantation
arm group type: Experimental
intervention type: Procedure
intervention name: Oral mucosa biopsy
arm group label: Tissue engineered construction implantation
intervention type: Procedure
intervention name: Sinus lift with implantation of tissue engineered construction
arm group label: Tissue engineered construction implantation
intervention type: Device
intervention name: Dental implant
arm group label: Tissue engineered construction implantation
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
last name: Grigory Volozhin A Volozhin, MD, PhD
role: Principal Investigator
affiliation: A.I. Evdokimov Moscow State Medical Stomatological University
last name: Ilya I Eremin, MD, PhD
role: Principal Investigator
affiliation: Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation; Center for Biomedical Technologies
facility: 
facility: 
country: Russian Federation
responsible party type: Sponsor
mesh term: Alveolar Bone Loss
mesh term: Atrophy