<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/NCT01677520</url>
  </required_header>
  <id_info>
    <org_study_id>12.08.004</org_study_id>
    <nct_id>NCT01677520</nct_id>
  </id_info>
  <brief_title>Investigation of Stem Cells in Human Lipoaspirate</brief_title>
  <official_title>Investigation of Adipose-Derived Stem Cells in Human Lipoaspirate</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nevada, Las Vegas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nevada, Las Vegas</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall purpose of this study is to enhance identification and isolation of ADSCs and&#xD;
      adipocytes, to find the optimum culturing conditions to increase growth and volume of grafts,&#xD;
      and to study the effects of cryopreservation on ADSCs and adipocytes. Fat injections are used&#xD;
      in aesthetic surgery but tend to disassemble over time. If the investigators can enhance&#xD;
      growth and volume of fat in culture, the investigators could use fat grafts in reconstruction&#xD;
      of cancer and traumatic injury defects with the patients own cultured fat cells and grafts.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2011</start_date>
  <completion_date type="Anticipated">August 2018</completion_date>
  <primary_completion_date type="Anticipated">August 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percent of Viable ADSCs</measure>
    <time_frame>Day of Surgery</time_frame>
    <description>Percent of viable ADSCs will be measured on fresh samples and samples refrigerated for different times.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent of Apoptotic ADSCs</measure>
    <time_frame>Day of Surgery</time_frame>
    <description>Percent of apoptotic ADSCs will be measured on fresh samples and on refrigerated samples at 1, 2, 3, and 4 days refrigerated storage.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Percent of Necrotic ADSCs</measure>
    <time_frame>Day of Surgery</time_frame>
    <description>Percent of necrotic ADSCs will be measured on fresh samples and on refrigerated samples at 1, 2, 3, and 4 days of refrigerated storage.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>18-30 yrs, 31-50 yrs, 51-70 yrs</arm_group_label>
    <description>No intervention</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Cells from lipoaspirate maximum of 20 days&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Primary Care Clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adults (18-70 yrs) who have scheduled surgical lipectomy of the hips, abdomen, or&#xD;
             thighs are prospective subjects for this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women will be excluded to protect the unborn child.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William A Zamboni, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNSOM</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wei Z Wang, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>wwang@medicine.nevada.edu</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>William A Zamboni, M.D.</last_name>
    <phone>702-671-2278</phone>
    <email>wzamboni@medicine.nevada.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Shelley J Williams, M.S.</last_name>
    <phone>702-895-1445</phone>
    <email>sjwilliams@medicine.nevada.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Nevada School of Medicine Patient Care Center</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89102</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>William A Zamboni, M.D.</last_name>
      <email>wzamboni@medicine.nevada.edu</email>
    </contact>
    <contact_backup>
      <last_name>Karen Zamboni, BSRN</last_name>
      <phone>702-671-5118</phone>
      <email>kzamboni@medicine.nevada.edu</email>
    </contact_backup>
    <investigator>
      <last_name>William A Zamboni, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>January 8, 2015</last_update_submitted>
  <last_update_submitted_qc>January 8, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 9, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Nevada, Las Vegas</investigator_affiliation>
    <investigator_full_name>William A. Zamboni, M.D.</investigator_full_name>
    <investigator_title>Professor and Chair Department of Surgery UNSOM</investigator_title>
  </responsible_party>
  <keyword>adipose-derived stem cells</keyword>
  <keyword>viable ADSCs</keyword>
  <keyword>apoptosis</keyword>
  <keyword>necrosis</keyword>
  <keyword>cryopreservation</keyword>
  <!-- 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/NCT01677520
org study id: 12.08.004
nct id: NCT01677520
lead sponsor: 
has dmc: No
The overall purpose of this study is to enhance identification and isolation of ADSCs and
      adipocytes, to find the optimum culturing conditions to increase growth and volume of grafts,
      and to study the effects of cryopreservation on ADSCs and adipocytes. Fat injections are used
      in aesthetic surgery but tend to disassemble over time. If the investigators can enhance
      growth and volume of fat in culture, the investigators could use fat grafts in reconstruction
      of cancer and traumatic injury defects with the patients own cultured fat cells and grafts.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Percent of Viable ADSCs
time frame: Day of Surgery
description: Percent of viable ADSCs will be measured on fresh samples and samples refrigerated for different times.
measure: Percent of Apoptotic ADSCs
time frame: Day of Surgery
description: Percent of apoptotic ADSCs will be measured on fresh samples and on refrigerated samples at 1, 2, 3, and 4 days refrigerated storage.
measure: Percent of Necrotic ADSCs
time frame: Day of Surgery
description: Percent of necrotic ADSCs will be measured on fresh samples and on refrigerated samples at 1, 2, 3, and 4 days of refrigerated storage.
arm group label: 18-30 yrs, 31-50 yrs, 51-70 yrs
description: No intervention
Cells from lipoaspirate maximum of 20 days
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: William A Zamboni, M.D.
role: Principal Investigator
affiliation: UNSOM
last name: Wei Z Wang, M.D.
role: Study Director
affiliation: wwang@medicine.nevada.edu
last name: William A Zamboni, M.D.
phone: 702-671-2278
email: wzamboni@medicine.nevada.edu
last name: Shelley J Williams, M.S.
phone: 702-895-1445
email: sjwilliams@medicine.nevada.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Nevada, Las Vegas
investigator full name: William A. Zamboni, M.D.
investigator title: Professor and Chair Department of Surgery UNSOM