Recruiting

SSC & Grafting

Sponsor:

University of Pittsburgh

Code:

NCT04452305

Conditions

Infertility, Male

Cancer

Autoimmune Disorder

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Spermatogonial Stem Cell Transplant and Testicular Tissue Grafting

Study Details

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.

Conditions

Infertility, Male

Cancer

Autoimmune Disorder

Study ID

NCT04452305

Start date

Nov 10, 2023

Status verified date

Apr, 2026

Completion date

May 31, 2030

Anticipated

Primary completion date

Dec 28, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Spermatogonial Stem Cell Transplant & Testicular Tissue Graft

Stem cell transplantation Testicular tissue grafting

Interventions

Spermatogonial Stem Cell Transplant and Testicular Tissue Grafting

Spermatogonial stem cell transplant and testicular tissue grafting is performed to produce sperm.

Primary outcome measure

  • Number of participants with return of spermatogenesis [ Time Frame: 3 months-1year ]

Central Contacts and Locations

Central contacts

Jennifer L Anglin

412-641-7475fertilitypreservation@upmc.edu

Locations

Magee-Womens Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Rachel Neelley

412-641-7475fertilitypreservation@upmc.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Keywords

  • spermatogonial stem cells
  • testis
  • fertility
  • oncofertility

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-04-22.