<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/NCT04452305</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY20030111</org_study_id>
    <nct_id>NCT04452305</nct_id>
  </id_info>
  <brief_title>Spermatogonial Stem Cell (SSC) Transplant and Testicular Tissue Grafting</brief_title>
  <official_title>Spermatogonial Stem Cell (SSC) Transplant and Testicular Tissue Grafting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>No</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>
      Spermatogonial stem cell transplantation through ultrasound guided rete testis injection and&#xD;
      testicular tissue grafting will be performed for participants who have frozen testicular&#xD;
      tissue prior to gonadotoxic therapy. The purpose of this study is to test the safety and&#xD;
      feasibility of these transplant technologies and restore fertility for these participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Azoospermia (no sperm in ejaculated semen) impacts 1% of men in the general population and&#xD;
      15% of infertile men, which translates to 645,000 males between the ages of 20 and 50 (prime&#xD;
      reproductive years) in the United States. Spermatogenesis arises from a population of&#xD;
      spermatogonial stem cells in the testes that maintain continuous sperm production throughout&#xD;
      a man's post-pubertal life. Diseases or medical treatments that compromise the stem cell pool&#xD;
      and/or prevent the stem cells from differentiating can cause infertility. Adult men have the&#xD;
      option to cryopreserve a semen sample prior to therapy but this is not an option for&#xD;
      prepubertal patients who are not yet producing sperm. This study will test the safety and&#xD;
      feasibility of two approaches to restore sperm production using previously cryopreserved&#xD;
      testicular tissues, which contain spermatogonial stem cells.&#xD;
&#xD;
      The first approach is autologous transplantation of testicular cells, including&#xD;
      spermatogonial stem cells, into the testis using ultrasound-guided rete testis injection. The&#xD;
      second approach is autologous grafting of intact pieces of testicular tissue under the skin&#xD;
      in the scrotum.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Anticipated">September 2023</start_date>
  <completion_date type="Anticipated">July 1, 2026</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2025</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with return of spermatogenesis</measure>
    <time_frame>3 months-1year</time_frame>
    <description>Rate of participants where sperm was found in semen analysis or testicular tissue analysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with cancer recurrence</measure>
    <time_frame>5 years</time_frame>
    <description>Rate of participants diagnosed with cancer recurrence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with surgical complications of SSC transplantation and testicular tissue grafting</measure>
    <time_frame>3 months</time_frame>
    <description>Rate of infection, hospital readmission, re-operation occurs</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Infertility, Male</condition>
  <condition>Cancer</condition>
  <condition>Autoimmune Disorder</condition>
  <arm_group>
    <arm_group_label>Spermatogonial Stem Cell Transplant &amp; Testicular Tissue Graft</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stem cell transplantation Testicular tissue grafting</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Spermatogonial Stem Cell Transplant and Testicular Tissue Grafting</intervention_name>
    <description>Spermatogonial stem cell transplant and testicular tissue grafting is performed to produce sperm.</description>
    <arm_group_label>Spermatogonial Stem Cell Transplant &amp; Testicular Tissue Graft</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male participant at least in Tanner stage 3&#xD;
&#xD;
          -  Previously cryopreserved and stored testicular tissue/cells (frozen due to an&#xD;
             infertility-risking diagnosis or treatment such as chemotherapy or radiation)&#xD;
             available for autologous transplantation and grafting&#xD;
&#xD;
          -  Healthy enough to undergo anesthesia&#xD;
&#xD;
          -  Written clearance for the procedure from the patient's hematologist or oncologist to&#xD;
             confirm the patient has finished treatment for primary condition and are clear to&#xD;
             undergo autologous stem cell transplant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants considered to be high risk for surgical complications&#xD;
&#xD;
          -  Participants with a history of leukemia, lymphoma or testicular cancer or a cancer&#xD;
             that likely involved testicles at the time of testicular tissue collection&#xD;
&#xD;
          -  Diagnosed with psychological, psychiatric, or other conditions which prevent giving&#xD;
             fully informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kyle E Orwig, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rachel Neelley</last_name>
    <phone>412-641-7475</phone>
    <phone_ext>1</phone_ext>
    <email>fertilitypreservation@upmc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Magee-Womens Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rachel Neelley</last_name>
      <phone>412-641-7475</phone>
      <phone_ext>1</phone_ext>
      <email>fertilitypreservation@upmc.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>April 13, 2023</last_update_submitted>
  <last_update_submitted_qc>April 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Kyle Orwig</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>spermatogonial stem cells</keyword>
  <keyword>testis</keyword>
  <keyword>fertility</keyword>
  <keyword>oncofertility</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Infertility, Male</mesh_term>
    <mesh_term>Autoimmune Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The investigators will publish individual participant data, after deidentification. The investigators will also report each individual participants data back to them. Participants will be identified with unique ID numbers. No identifiable information will be shared.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Beginning 9 months and ending 36 months following article publication.</ipd_time_frame>
    <ipd_access_criteria>Researchers who provide a methodologically sound proposal. Proposals should be directed at korwig@mwri.magee.edu</ipd_access_criteria>
  </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/NCT04452305
org study id: STUDY20030111
nct id: NCT04452305
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Spermatogonial stem cell transplantation through ultrasound guided rete testis injection and
      testicular tissue grafting will be performed for participants who have frozen testicular
      tissue prior to gonadotoxic therapy. The purpose of this study is to test the safety and
      feasibility of these transplant technologies and restore fertility for these participants.
Azoospermia (no sperm in ejaculated semen) impacts 1% of men in the general population and
      15% of infertile men, which translates to 645,000 males between the ages of 20 and 50 (prime
      reproductive years) in the United States. Spermatogenesis arises from a population of
      spermatogonial stem cells in the testes that maintain continuous sperm production throughout
      a man's post-pubertal life. Diseases or medical treatments that compromise the stem cell pool
      and/or prevent the stem cells from differentiating can cause infertility. Adult men have the
      option to cryopreserve a semen sample prior to therapy but this is not an option for
      prepubertal patients who are not yet producing sperm. This study will test the safety and
      feasibility of two approaches to restore sperm production using previously cryopreserved
      testicular tissues, which contain spermatogonial stem cells.

      The first approach is autologous transplantation of testicular cells, including
      spermatogonial stem cells, into the testis using ultrasound-guided rete testis injection. The
      second approach is autologous grafting of intact pieces of testicular tissue under the skin
      in the scrotum.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with return of spermatogenesis
time frame: 3 months-1year
description: Rate of participants where sperm was found in semen analysis or testicular tissue analysis
measure: Number of participants with cancer recurrence
time frame: 5 years
description: Rate of participants diagnosed with cancer recurrence
measure: Number of participants with surgical complications of SSC transplantation and testicular tissue grafting
time frame: 3 months
description: Rate of infection, hospital readmission, re-operation occurs
arm group label: Spermatogonial Stem Cell Transplant & Testicular Tissue Graft
arm group type: Experimental
description: Stem cell transplantation Testicular tissue grafting
intervention type: Procedure
intervention name: Spermatogonial Stem Cell Transplant and Testicular Tissue Grafting
description: Spermatogonial stem cell transplant and testicular tissue grafting is performed to produce sperm.
arm group label: Spermatogonial Stem Cell Transplant & Testicular Tissue Graft
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Kyle E Orwig, PhD
role: Principal Investigator
affiliation: University of Pittsburgh
last name: Rachel Neelley
phone: 412-641-7475
phone ext: 1
email: fertilitypreservation@upmc.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Kyle Orwig
investigator title: Professor
mesh term: Infertility
mesh term: Infertility, Male
mesh term: Autoimmune Diseases
sharing ipd: Yes
ipd description: The investigators will publish individual participant data, after deidentification. The investigators will also report each individual participants data back to them. Participants will be identified with unique ID numbers. No identifiable information will be shared.
ipd info type: Study Protocol
ipd time frame: Beginning 9 months and ending 36 months following article publication.
ipd access criteria: Researchers who provide a methodologically sound proposal. Proposals should be directed at korwig@mwri.magee.edu