<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/NCT04503161</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-52778</org_study_id>
    <nct_id>NCT04503161</nct_id>
  </id_info>
  <brief_title>The Effect of an ASC-seeded Collagen Hydrogel on Cerebrospinal Fluid Leak Rates Following Skull Base Surgery</brief_title>
  <official_title>The Effect of an ASC-seeded Collagen Hydrogel on Cerebrospinal Fluid Leak Rates Following Skull Base Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project seeks to test whether a cell-seeded collagen hydrogel dressing can reduce CSF&#xD;
      leak after skull base surgery. Normally, patients at risk for CSF leak are treated with a&#xD;
      commercial collagen matrix called Duragen. In this study, our sterile, cGMP manufactured&#xD;
      collagen hydrogel dressing will be seeded with the stromal vascular fraction (SVF)&#xD;
      mechanically isolated from lipoaspirate taken intra-operatively. This SVF contains&#xD;
      pro-regenerative adipose stem cells (ASCs). The ASC-seeded hydrogel will be used as a&#xD;
      supplement to Duragen to reinforce the skull base closure. The goal is to establish safety as&#xD;
      well as to secondarily evaluate for effectiveness in reducing CSF leak postoperatively.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Investigator left institution&#xD;
  </why_stopped>
  <start_date type="Anticipated">September 2021</start_date>
  <completion_date type="Anticipated">September 2022</completion_date>
  <primary_completion_date type="Anticipated">September 2022</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of CSF leak</measure>
    <time_frame>6 months active participation (date of surgery + 6 months follow up via chart review)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>6 months active participation (date of surgery + 6 months follow up via chart review)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for reoperation</measure>
    <time_frame>6 months active participation (date of surgery + 6 months follow up via chart review)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative hematoma</measure>
    <time_frame>6 months active participation (date of surgery + 6 months follow up via chart review)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative infection</measure>
    <time_frame>6 months active participation (date of surgery + 6 months follow up via chart review)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for rehospitalization</measure>
    <time_frame>6 months active participation (date of surgery + 6 months follow up via chart review)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death</measure>
    <time_frame>6 months active participation (date of surgery + 6 months follow up via chart review)</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>CSF Leak</condition>
  <arm_group>
    <arm_group_label>Hydrogel recipient</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Duragen with Collagen Hydrodel and ASCs</intervention_name>
    <description>Duragen combined with collagen hydrogel and patient's stem cells</description>
    <arm_group_label>Hydrogel recipient</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;/= 18&#xD;
&#xD;
          -  Planned for skull base surgery&#xD;
&#xD;
          -  Able to understand and willing to sign a written informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  active skull base infection&#xD;
&#xD;
          -  no plan for DuraGen repair by operating surgeon&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 23, 2022</last_update_submitted>
  <last_update_submitted_qc>August 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 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>Cerebrospinal Fluid Leak</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Estradiol 17 beta-cypionate</mesh_term>
    <mesh_term>Estradiol 3-benzoate</mesh_term>
    <mesh_term>Estradiol</mesh_term>
    <mesh_term>Polyestradiol phosphate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04503161
org study id: IRB-52778
nct id: NCT04503161
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
This project seeks to test whether a cell-seeded collagen hydrogel dressing can reduce CSF
      leak after skull base surgery. Normally, patients at risk for CSF leak are treated with a
      commercial collagen matrix called Duragen. In this study, our sterile, cGMP manufactured
      collagen hydrogel dressing will be seeded with the stromal vascular fraction (SVF)
      mechanically isolated from lipoaspirate taken intra-operatively. This SVF contains
      pro-regenerative adipose stem cells (ASCs). The ASC-seeded hydrogel will be used as a
      supplement to Duragen to reinforce the skull base closure. The goal is to establish safety as
      well as to secondarily evaluate for effectiveness in reducing CSF leak postoperatively.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Rate of CSF leak
time frame: 6 months active participation (date of surgery + 6 months follow up via chart review)
measure: Length of hospital stay
time frame: 6 months active participation (date of surgery + 6 months follow up via chart review)
measure: Need for reoperation
time frame: 6 months active participation (date of surgery + 6 months follow up via chart review)
measure: Postoperative hematoma
time frame: 6 months active participation (date of surgery + 6 months follow up via chart review)
measure: Postoperative infection
time frame: 6 months active participation (date of surgery + 6 months follow up via chart review)
measure: Need for rehospitalization
time frame: 6 months active participation (date of surgery + 6 months follow up via chart review)
measure: Death
time frame: 6 months active participation (date of surgery + 6 months follow up via chart review)
arm group label: Hydrogel recipient
arm group type: Experimental
intervention type: Device
intervention name: Duragen with Collagen Hydrodel and ASCs
description: Duragen combined with collagen hydrogel and patient's stem cells
arm group label: Hydrogel recipient
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Cerebrospinal Fluid Leak
mesh term: Estradiol 17 beta-cypionate
mesh term: Estradiol 3-benzoate
mesh term: Estradiol
mesh term: Polyestradiol phosphate
sharing ipd: No