NCT04452305

Spermatogonial Stem Cell (SSC) Transplant and Testicular Tissue Grafting

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Infertility, Male
• Cancer
• Autoimmune Disorder

Interventions

Type	Name	Description
PROCEDURE	Spermatogonial Stem Cell Transplant and Testicular Tissue Grafting	Spermatogonial stem cell transplant and testicular tissue grafting is performed to produce sperm.

Timeline

• Start date: 2023-11-10
• Primary completion: 2027-07-01
• Completion: 2028-07-01
• First posted: 2020-06-30
• Last updated: 2025-12-10

Locations

1 site across 1 country: United States