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Spermatogonial Stem Cell (SSC) Transplant and Testicular Tissue Grafting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04452305
Recruitment Status : Recruiting
First Posted : June 30, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Kyle Orwig, University of Pittsburgh

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Infertility, Male Cancer Autoimmune Disorder Procedure: Spermatogonial Stem Cell Transplant and Testicular Tissue Grafting Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Spermatogonial Stem Cell (SSC) Transplant and Testicular Tissue Grafting
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : July 1, 2025
Estimated Study Completion Date : July 1, 2026


Arm Intervention/treatment
Experimental: Spermatogonial Stem Cell Transplant & Testicular Tissue Graft
Stem cell transplantation Testicular tissue grafting
Procedure: Spermatogonial Stem Cell Transplant and Testicular Tissue Grafting
Spermatogonial stem cell transplant and testicular tissue grafting is performed to produce sperm.




Primary Outcome Measures :
  1. Number of participants with return of spermatogenesis [ Time Frame: 3 months-1year ]
    Rate of participants where sperm was found in semen analysis or testicular tissue analysis


Secondary Outcome Measures :
  1. Number of participants with cancer recurrence [ Time Frame: 5 years ]
    Rate of participants diagnosed with cancer recurrence

  2. Number of participants with surgical complications of SSC transplantation and testicular tissue grafting [ Time Frame: 3 months ]
    Rate of infection, hospital readmission, re-operation occurs



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male participant at least in Tanner stage 3
  • Previously cryopreserved and stored testicular tissue/cells (frozen due to an infertility-risking diagnosis or treatment such as chemotherapy or radiation) available for autologous transplantation and grafting
  • Healthy enough to undergo anesthesia
  • Written clearance for the procedure from the patient's hematologist or oncologist to confirm the patient has finished treatment for primary condition and are clear to undergo autologous stem cell transplant

Exclusion Criteria:

  • Participants considered to be high risk for surgical complications
  • Participants with a history of leukemia, lymphoma or testicular cancer or a cancer that likely involved testicles at the time of testicular tissue collection
  • Diagnosed with psychological, psychiatric, or other conditions which prevent giving fully informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04452305


Contacts
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Contact: Sarah R Steimer, MS 412-641-2700 steimersr2@upmc.edu
Contact: Katherine V McMahon, MA 412-641-2232 samskv@upmc.edu

Locations
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United States, Pennsylvania
Magee-Womens Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Kyle E Orwig, PhD    412-641-7475    orwigke@upmc.edu   
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: Kyle E Orwig, PhD University of Pittsburgh
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Responsible Party: Kyle Orwig, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04452305    
Other Study ID Numbers: STUDY20030111
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan 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.
Supporting Materials: Study Protocol
Time Frame: Beginning 9 months and ending 36 months following article publication.
Access Criteria: Researchers who provide a methodologically sound proposal. Proposals should be directed at korwig@mwri.magee.edu

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kyle Orwig, University of Pittsburgh:
spermatogonial stem cells
testis
fertility
oncofertility
Additional relevant MeSH terms:
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Infertility
Infertility, Male
Autoimmune Diseases
Genital Diseases, Male
Genital Diseases, Female
Immune System Diseases