Transplanting stem cells and grafting testicular tissue to restore male fertility
Spermatogonial Stem Cell (SSC) Transplant and Testicular Tissue Grafting
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Sex | Male |
| Sponsor | University of Pittsburgh Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT04452305 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are males in Tanner stage 3 or higher who have cryopreserved testicular tissue due to infertility-risking diagnoses.
Not a fit: Patients with a history of certain cancers or those at high risk for surgical complications may not benefit from this study.
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 performed: While the approaches being tested are innovative, similar studies in spermatogonial stem cell transplantation have shown promise, indicating potential for success.
Eligibility criteria
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 this trial is running
Pittsburgh, Pennsylvania
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.