Clinical trial · Interventional
Spermatogonial Stem Cell (SSC) Transplant and Testicular Tissue Grafting
NCT04452305CI-TRIAL-00109092recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Autoimmune Disorder | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Infertility, Male | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Spermatogonial Stem Cell Transplant and Testicular Tissue Grafting | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Spermatogonial Stem Cell Transplant & Testicular Tissue Graft
- description
- Stem cell transplantation Testicular tissue grafting
- interventionNames
- Procedure: Spermatogonial Stem Cell Transplant and Testicular Tissue Grafting
Primary outcomes (1)
- measure
- Number of participants with return of spermatogenesis
- timeFrame
- 3 months-1year
- description
- Rate of participants where sperm was found in semen analysis or testicular tissue analysis
Secondary outcomes (2)
- measure
- Number of participants with cancer recurrence
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDZielen AC, Peters KA, Shetty G, Gross DA, Hanna CB, Dovey SL, Wecht A, Cannon GM, Meistrich ML, Hsieh M, Hwang K, Orwig KE. Ultrasound-Guided Rete Testis Approach to Sperm Aspiration and Spermatogonial Stem Cell Transplantation in Patients with Azoospermia. medRxiv [Preprint]. 2025 Mar 26:2025.03.25.25324518. doi: 10.1101/2025.03.25.25324518. PMID 40365444