<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/NCT03258164</url>
  </required_header>
  <id_info>
    <org_study_id>H-16046960</org_study_id>
    <nct_id>NCT03258164</nct_id>
  </id_info>
  <brief_title>Cosmetic Fat Transplantation Using Expanded ASC Enriched Fat Grafts</brief_title>
  <official_title>Fat Transplantation Enriched With Expanded Adipose-derived Autologous Mesenchymal Stromal Cells in Cosmetic Breast Augmentation and Cosmetic Facial Filling</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stemform</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aleris-Hamlet Hospitaler København</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Stemform</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>
      The purpose of the present study is to examine whether enrichment of a fat graft with&#xD;
      autologous ex vivo expanded ASC injected into the breast tissue or face, both for cosmetic&#xD;
      use, will significantly improve the results of conventional lipofilling and synthetic facial&#xD;
      fillers, thereby being able to offer a safer, more natural and long-lasting alternative to&#xD;
      current artificial solutions for cosmetic patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The cosmetic breast augmentation design is a double-blind (surgeon and data assessor)&#xD;
      randomized, prospective clinical study on healthy subjects.&#xD;
&#xD;
      The cosmetic facial filling design is a data assessor-blinded, randomized, prospective&#xD;
      clinical study on healthy subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 22, 2017</start_date>
  <completion_date type="Actual">November 22, 2022</completion_date>
  <primary_completion_date type="Actual">October 24, 2022</primary_completion_date>
  <phase>Phase 3</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>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in volume over time after breast augmentation</measure>
    <time_frame>Baseline, four and twelve months</time_frame>
    <description>Measurement of the residual volume of fat transplants as based on MRI before operation (baseline), and four and twelve months after lipo-injection to the breast in order to determine the difference in volume between baseline and 4 months and 12 months post operative; and thereby the resorption rate over time.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in cosmetic facial appearance over time after facial filling</measure>
    <time_frame>Baseline, one, four and twelve months</time_frame>
    <description>Assessment of cosmetic outcome based on clinical photos before (baseline), one, four and twelve months after the procedure when compared to baseline, evaluated by 5 independent plastic surgeons blinded to the intervention using a scale of 1-5 to determine the difference in appearance over time.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Breast Hypoplasia and Facial Ageing</condition>
  <arm_group>
    <arm_group_label>ASC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ASC enriched lipofilling</intervention_name>
    <description>Fat grafts enriched with ex vivo expanded ASC</description>
    <arm_group_label>ASC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Standard Lipofilling</intervention_name>
    <description>Non-ASC enriched fat grafts</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Criteria breast augmentation:&#xD;
&#xD;
        Inclusion criteria&#xD;
&#xD;
          1. Age 18 - 50 years&#xD;
&#xD;
          2. Healthy females&#xD;
&#xD;
          3. BMI 18 - 30 kg/m2&#xD;
&#xD;
          4. 1000 ml of fat (lipoaspirate) available for liposuction at the abdomen and/or thighs&#xD;
&#xD;
          5. Desire for breast augmentation&#xD;
&#xD;
          6. Speaks and reads Danish or English&#xD;
&#xD;
          7. Signed informed consent&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          1. Smoking&#xD;
&#xD;
          2. Previous breast surgery&#xD;
&#xD;
          3. Previous cancer or predisposition to breast cancer&#xD;
&#xD;
          4. Pregnancy or planned pregnancy within one year after the procedure&#xD;
&#xD;
          5. Breastfeeding less than 6 months prior to inclusion&#xD;
&#xD;
          6. Weight gain or loss above 2 BMI point&#xD;
&#xD;
          7. Known chronic disease associated with metabolism malfunction or pour healing&#xD;
&#xD;
          8. Pacemaker or other implanted foreign objects&#xD;
&#xD;
          9. Allergy towards necessary anaesthesia&#xD;
&#xD;
         10. Intention of weight loss or weight gain within the trial period&#xD;
&#xD;
        Criteria fascial filling&#xD;
&#xD;
        Inclusion criteria&#xD;
&#xD;
          1. Age 25 - 65 years&#xD;
&#xD;
          2. Healthy females&#xD;
&#xD;
          3. BMI 18 - 30 kg/m2&#xD;
&#xD;
          4. 100 ml of fat (lipoaspirate) available for liposuction at the abdomen and/or thighs&#xD;
&#xD;
          5. Desire for facial wrinkle treatment and facial augmentation (rejuvenation)&#xD;
&#xD;
          6. Speaks and reads Danish or English&#xD;
&#xD;
          7. Signed informed consent&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          1. Smoking&#xD;
&#xD;
          2. Previous facial surgery&#xD;
&#xD;
          3. Previous cancer&#xD;
&#xD;
          4. Pregnancy or planned pregnancy within one year after the procedure&#xD;
&#xD;
          5. Known chronic disease associated with metabolism malfunction or poor healing&#xD;
&#xD;
          6. Allergy towards necessary anaesthesia&#xD;
&#xD;
          7. Intention of weight loss or weight gain within the trial period&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stig-Frederik T Kølle, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stemform</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stemform</name>
      <address>
        <city>Copenhagen</city>
        <state>Søborg</state>
        <zip>2860</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>November 24, 2022</last_update_submitted>
  <last_update_submitted_qc>November 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2022</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>Facies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Results will be published in international medical journals</ipd_description>
  </patient_data>
  <!-- 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/NCT03258164
org study id: H-16046960
nct id: NCT03258164
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of the present study is to examine whether enrichment of a fat graft with
      autologous ex vivo expanded ASC injected into the breast tissue or face, both for cosmetic
      use, will significantly improve the results of conventional lipofilling and synthetic facial
      fillers, thereby being able to offer a safer, more natural and long-lasting alternative to
      current artificial solutions for cosmetic patients.
The cosmetic breast augmentation design is a double-blind (surgeon and data assessor)
      randomized, prospective clinical study on healthy subjects.

      The cosmetic facial filling design is a data assessor-blinded, randomized, prospective
      clinical study on healthy subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Care Provider, Outcomes Assessor)
measure: Change in volume over time after breast augmentation
time frame: Baseline, four and twelve months
description: Measurement of the residual volume of fat transplants as based on MRI before operation (baseline), and four and twelve months after lipo-injection to the breast in order to determine the difference in volume between baseline and 4 months and 12 months post operative; and thereby the resorption rate over time.
measure: Change in cosmetic facial appearance over time after facial filling
time frame: Baseline, one, four and twelve months
description: Assessment of cosmetic outcome based on clinical photos before (baseline), one, four and twelve months after the procedure when compared to baseline, evaluated by 5 independent plastic surgeons blinded to the intervention using a scale of 1-5 to determine the difference in appearance over time.
arm group label: ASC
arm group type: Experimental
arm group label: Control
arm group type: Active Comparator
intervention type: Biological
intervention name: ASC enriched lipofilling
description: Fat grafts enriched with ex vivo expanded ASC
arm group label: ASC
intervention type: Biological
intervention name: Standard Lipofilling
description: Non-ASC enriched fat grafts
arm group label: Control
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stig-Frederik T Kølle, MD, PhD
role: Principal Investigator
affiliation: Stemform
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Facies
sharing ipd: No
ipd description: Results will be published in international medical journals