<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/NCT02206672</url>
  </required_header>
  <id_info>
    <org_study_id>2014-A01014-43</org_study_id>
    <secondary_id>2014-12</secondary_id>
    <nct_id>NCT02206672</nct_id>
  </id_info>
  <brief_title>EFFECTS OF THE MICRO REINJECTION OF AUTOLOGOUS ADIPOSE TISSUE IN THE FACE OF PATIENTS WITH SYSTEMIC SCLEROSIS</brief_title>
  <acronym>FACE</acronym>
  <official_title>EFFECTS OF THE MICRO REINJECTION OF AUTOLOGOUS ADIPOSE TISSUE IN THE FACE OF PATIENTS WITH SYSTEMIC SCLEROSIS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective single-center study evaluates a current care procedure. It includes 14&#xD;
      patients diagnosed with SSc according to the ACR/EULAR criteria or the Leroy &amp; Medsger&#xD;
      criteria of the disease. Patients are enrolled if they wish for a therapeutic care of their&#xD;
      face, have a Mouth Handicap in Systemic Sclerosis (MHISS) score greater than 20 (scale 0-48),&#xD;
      a modified Rodnan skin score upper or equal to 1 on the face (scale 0-3), and a mouth opening&#xD;
      less than 55 millimeters. They should not have anticoagulant, anti-platelets aggregation&#xD;
      medication or a daily steroid dose upper 20mg per day. Their BMI should exceed 17.&#xD;
&#xD;
      Micro fat grafting is a minimally invasive and usual procedure performed under local&#xD;
      anesthesia. Fat tissue is harvested (around 50 milliliters) using a 14 gauge or 2 mm diameter&#xD;
      cannula from areas around the knees, the abdomen or the hips under a gentle aspiration.&#xD;
      Lipoaspirated fat is then filtrated by the PureGraft system that offers a sterile, closed,&#xD;
      single-use system, leading to a fast, consistent and controlled preparation. Then, 10 to 25&#xD;
      milliliters of this purified fat product is transferred through a 21 gauge or 0.8 mm diameter&#xD;
      cannula in two or four points of the face, with the entry points located around the mouth.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">November 2015</completion_date>
  <primary_completion_date type="Anticipated">November 2015</primary_completion_date>
  <phase>N/A</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>improvement of the MHISS score</measure>
    <time_frame>12 months</time_frame>
    <description>The MHISS questionnaire is chosen as it specifically assesses disability involving the mouth and the face in SSc patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>evaluate the effect of the procedure on quality of life</measure>
    <time_frame>12 months</time_frame>
    <description>Health Assessment Questionnaire adapted to scleroderma, SHAQ</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>evaluate the effect of the procedure on face pain</measure>
    <time_frame>12 months</time_frame>
    <description>face pain scale (VAS 0-100)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>evaluate the effect of the procedure on skin fibrosis</measure>
    <time_frame>12 months</time_frame>
    <description>skin fibrosis is measured by Rodnan skin score for the face, mouth opening measure and cutometry)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>evaluate the effect of the procedure on physical face changes</measure>
    <time_frame>12 months</time_frame>
    <description>physical face changes is evaluated by standard and 3D photographs.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Systemic Sclerosis</condition>
  <arm_group>
    <arm_group_label>Micro reinjection of autologus adipose tissue</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Micro reinjection of autologus adipose tissue</intervention_name>
    <arm_group_label>Micro reinjection of autologus adipose tissue</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 18 or younger than 80 years.&#xD;
&#xD;
          -  Suffering from systemic scleroderma.&#xD;
&#xD;
          -  Patient follow-AP-HM.&#xD;
&#xD;
          -  Score of 20 or greater MHISS.&#xD;
&#xD;
          -  Score Rodnan level greater than or equal to one face.&#xD;
&#xD;
          -  Mouth opening (inter-incisor distance) &lt;5.5 cm&#xD;
&#xD;
          -  Wishing to receive surgery at the face.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 18 or greater than 80 age.&#xD;
&#xD;
          -  Decaying history of abdominal surgery.&#xD;
&#xD;
          -  Body mass index lower than 18.&#xD;
&#xD;
          -  Coagulation disorders.&#xD;
&#xD;
          -  Allergy to Xylocaine.&#xD;
&#xD;
          -  Greater than 20mg / d steroids.&#xD;
&#xD;
          -  Severe infection.&#xD;
&#xD;
          -  Inmates.&#xD;
&#xD;
          -  Pregnant women.&#xD;
&#xD;
          -  Adults protected by law (under guardianship and trusteeship).&#xD;
&#xD;
          -  No affiliation to a social security scheme.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>brigitte GRANEL, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>AP HM</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>brigitte GRANEL</last_name>
    <email>brigitte.granel@ap-hm.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assistance Publique Hopitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13354</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>BRIGITTE GRANEL</last_name>
      <email>brigitte.granel@ap-hm.fr</email>
    </contact>
    <investigator>
      <last_name>brigitte GRANEL</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>November 4, 2015</last_update_submitted>
  <last_update_submitted_qc>November 4, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 5, 2015</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>Scleroderma, Systemic</mesh_term>
    <mesh_term>Scleroderma, Diffuse</mesh_term>
    <mesh_term>Sclerosis</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/NCT02206672
org study id: 2014-A01014-43
secondary id: 2014-12
nct id: NCT02206672
lead sponsor: 
has dmc: No
This prospective single-center study evaluates a current care procedure. It includes 14
      patients diagnosed with SSc according to the ACR/EULAR criteria or the Leroy & Medsger
      criteria of the disease. Patients are enrolled if they wish for a therapeutic care of their
      face, have a Mouth Handicap in Systemic Sclerosis (MHISS) score greater than 20 (scale 0-48),
      a modified Rodnan skin score upper or equal to 1 on the face (scale 0-3), and a mouth opening
      less than 55 millimeters. They should not have anticoagulant, anti-platelets aggregation
      medication or a daily steroid dose upper 20mg per day. Their BMI should exceed 17.

      Micro fat grafting is a minimally invasive and usual procedure performed under local
      anesthesia. Fat tissue is harvested (around 50 milliliters) using a 14 gauge or 2 mm diameter
      cannula from areas around the knees, the abdomen or the hips under a gentle aspiration.
      Lipoaspirated fat is then filtrated by the PureGraft system that offers a sterile, closed,
      single-use system, leading to a fast, consistent and controlled preparation. Then, 10 to 25
      milliliters of this purified fat product is transferred through a 21 gauge or 0.8 mm diameter
      cannula in two or four points of the face, with the entry points located around the mouth.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: improvement of the MHISS score
time frame: 12 months
description: The MHISS questionnaire is chosen as it specifically assesses disability involving the mouth and the face in SSc patients.
measure: evaluate the effect of the procedure on quality of life
time frame: 12 months
description: Health Assessment Questionnaire adapted to scleroderma, SHAQ
measure: evaluate the effect of the procedure on face pain
time frame: 12 months
description: face pain scale (VAS 0-100)
measure: evaluate the effect of the procedure on skin fibrosis
time frame: 12 months
description: skin fibrosis is measured by Rodnan skin score for the face, mouth opening measure and cutometry)
measure: evaluate the effect of the procedure on physical face changes
time frame: 12 months
description: physical face changes is evaluated by standard and 3D photographs.
arm group label: Micro reinjection of autologus adipose tissue
arm group type: Other
intervention type: Other
intervention name: Micro reinjection of autologus adipose tissue
arm group label: Micro reinjection of autologus adipose tissue
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: brigitte GRANEL, MD
role: Principal Investigator
affiliation: AP HM
last name: brigitte GRANEL
email: brigitte.granel@ap-hm.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Scleroderma, Systemic
mesh term: Scleroderma, Diffuse
mesh term: Sclerosis