Transplanting stem cells and grafting testicular tissue to restore male fertility
Official title: Spermatogonial Stem Cell (SSC) Transplant and Testicular Tissue Grafting
Run by University of Pittsburgh · NCT04452305 · Data updated 2026-11-12
This study is testing if transplanting stem cells and grafting testicular tissue can help restore fertility in men who have stored their testicular tissue due to cancer treatments.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | Men only |
| Enrollment | 10 (estimated) |
| Sponsor | University of Pittsburgh Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Status | Recruiting |
| Started | November 10, 2023 |
| Main results expected | December 28, 2029 |
| Study ends | May 31, 2030 |
| Registry record updated | April 22, 2026 |
| Trial ID | NCT04452305 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are males in Tanner stage 3 or higher who have cryopreserved testicular tissue due to infertility-risking diagnoses.
✕Probably not a fit
Patients with a history of certain cancers or those at high risk for surgical complications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the safety and feasibility of spermatogonial stem cell transplantation and testicular tissue grafting in men who have previously cryopreserved testicular tissue due to infertility risks from cancer treatments. Participants will undergo ultrasound-guided injection of testicular cells or grafting of testicular tissue to restore sperm production. The study focuses on men who are in Tanner stage 3 or higher and have completed their primary treatment for conditions that risk fertility. By utilizing previously frozen testicular tissues, the study seeks to provide innovative solutions for male infertility.
Why it matters
Potential benefit: If successful, this approach could restore fertility in men who have lost their ability to produce sperm due to medical treatments.
How similar studies have gone: While the approaches being tested are innovative, similar studies in spermatogonial stem cell transplantation have shown promise, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States Recruiting
Study contacts
- Principal investigator: Kyle E Orwig, PhD — University of Pittsburgh
- Study coordinator: Jennifer L Anglin
- Email: fertilitypreservation@upmc.edu
- Phone: 412-641-7475
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.