<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/NCT04465929</url>
  </required_header>
  <id_info>
    <org_study_id>20190453-EAP</org_study_id>
    <nct_id>NCT04465929</nct_id>
  </id_info>
  <brief_title>Expanded Access - Autologous Human Schwann Cells in Peripheral Nerve Repair</brief_title>
  <official_title>Expanded Access - The Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation of Nerve Autografts After Severe Peripheral Nerve Injury (PNI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>W. Dalton Dietrich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Miami</source>
  <brief_summary>
    <textblock>
      Emergency expanded access for a single patient was granted to receive autologous human&#xD;
      Schwann cell (ahSC) augmentation of nerve autograft repair after severe peripheral nerve&#xD;
      injury (PNI).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>No longer available</overall_status>
  <study_type>Expanded Access</study_type>
  <expanded_access_info>
    <expanded_access_type_individual>Yes</expanded_access_type_individual>
  </expanded_access_info>
  <condition>Peripheral Nerve Injuries</condition>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Autologous Human Schwann Cells</intervention_name>
    <description>Schwann cells harvested from the sural nerve and debrided, injured sciatic nerve of the participant will be autologously transplanted along sural nerve autografts wrapped in a collagen matrix</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Persons with severe sciatic nerve injury, brachial plexus injury, and/or major injury&#xD;
             at the upper or lower extremity with nerve loss within previous year;&#xD;
&#xD;
          -  Peripheral nerve injury with large gap (5 - 10 cm) between healthy nerve endings;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Persons unable to safely undergo an MRI (may include persons with an implanted device&#xD;
             or metallic fragments which may interfere with MRI safety);&#xD;
&#xD;
          -  Persons with pre-existing conditions that would preclude satisfactory sural nerve&#xD;
             harvest (may include amputation or major injury to lower limb, or disease affecting&#xD;
             the sural nerve);&#xD;
&#xD;
          -  Persons with severe peripheral nerve injury gap length &gt; 10 cm in length;&#xD;
&#xD;
          -  Persons with history of radiation or local cancer in area of nerve injury, including&#xD;
             primary tumors of the nerve;&#xD;
&#xD;
          -  Pregnant women or a positive pregnancy test in those women with reproductive potential&#xD;
             prior to transplantation;&#xD;
&#xD;
          -  Presence of disease that might interfere with participant&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Allan D. Levi, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>W. Dalton Dietrich</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Nerve Injuries</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/NCT04465929
org study id: 20190453-EAP
nct id: NCT04465929
lead sponsor: 
Emergency expanded access for a single patient was granted to receive autologous human
      Schwann cell (ahSC) augmentation of nerve autograft repair after severe peripheral nerve
      injury (PNI).
expanded access type individual: Yes
intervention type: Biological
intervention name: Autologous Human Schwann Cells
description: Schwann cells harvested from the sural nerve and debrided, injured sciatic nerve of the participant will be autologously transplanted along sural nerve autografts wrapped in a collagen matrix
criteria: 
gender: Female
minimum age: 16 Years
maximum age: 16 Years
last name: Allan D. Levi, MD, PhD
role: Principal Investigator
affiliation: University of Miami
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Miami
investigator full name: W. Dalton Dietrich
investigator title: Professor
mesh term: Peripheral Nerve Injuries