Spermatogonial Stem Cell (SSC) Transplant and Testicular Tissue Grafting
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|ClinicalTrials.gov Identifier: NCT04452305|
Recruitment Status : Recruiting
First Posted : June 30, 2020
Last Update Posted : July 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Infertility, Male Cancer Autoimmune Disorder||Procedure: Spermatogonial Stem Cell Transplant and Testicular Tissue Grafting||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Spermatogonial Stem Cell (SSC) Transplant and Testicular Tissue Grafting|
|Estimated Study Start Date :||October 2020|
|Estimated Primary Completion Date :||July 1, 2025|
|Estimated Study Completion Date :||July 1, 2026|
Experimental: Spermatogonial Stem Cell Transplant & Testicular Tissue Graft
Stem cell transplantation Testicular tissue grafting
Procedure: Spermatogonial Stem Cell Transplant and Testicular Tissue Grafting
Spermatogonial stem cell transplant and testicular tissue grafting is performed to produce sperm.
- Number of participants with return of spermatogenesis [ Time Frame: 3 months-1year ]Rate of participants where sperm was found in semen analysis or testicular tissue analysis
- Number of participants with cancer recurrence [ Time Frame: 5 years ]Rate of participants diagnosed with cancer recurrence
- Number of participants with surgical complications of SSC transplantation and testicular tissue grafting [ Time Frame: 3 months ]Rate of infection, hospital readmission, re-operation occurs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04452305
|Contact: Sarah R Steimer, MSemail@example.com|
|Contact: Katherine V McMahon, MAfirstname.lastname@example.org|
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Kyle E Orwig, PhD 412-641-7475 email@example.com|
|Principal Investigator:||Kyle E Orwig, PhD||University of Pittsburgh|