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Male Urogenital Diseases

Stem cell transplantation Testicular tissue grafting

Spermatogonial stem cell transplant and testicular tissue grafting is performed to produce sperm.

Spermatogonial Stem Cell Transplant and Testicular Tissue Grafting

Rachel Neelley

Kyle E Orwig, PhD

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.

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.

Spermatogonial Stem Cell (SSC) Transplant and Testicular Tissue Grafting

The investigators will publish individual participant data, after deidentification. The investigators will also report each individual participants data back to them. Participants will be identified with unique ID numbers. No identifiable information will be shared.

Rate of participants where sperm was found in semen analysis or testicular tissue analysis

Rate of participants diagnosed with cancer recurrence

Rate of infection, hospital readmission, re-operation occurs

University of Pittsburgh

Professor

Testicular biopsy is performed to obtain testicular tissue for cryopreservation

Testicular biopsy

Kyle Orwig, PhD

Testicular tissue cryopreservation is an experimental procedure where a young boy's testicular tissue is retrieved and frozen. This technique is reserved for young male patients who are not yet producing mature sperm, with the ultimate goal that their tissue may be used in the future to restore fertility when experimental techniques emerge from the research pipeline.

Fertility status has an important impact on the post-treatment quality of life for cancer survivors and other patients that receive gonadotoxic therapies (e.g., prior to bone marrow transplantation). Semen cryopreservation is an established fertility preserving therapy, but is not accessible or appropriate for all men. Currently there are no therapies to preserve the future fertility of preadolescent boys. However, new reproductive therapies are under development and may one day offer "fertile hope" to those survivors that do not currently have access to fertility preserving therapies. Clinical management of fertility threatening diseases and treatments must have foresight of the gonadotoxic side effects and the potential for infertility. When no established fertility sparing options are available, it is reasonable to offer harvesting and cryopreservation of testicular tissue as a possible means of fertility preservation.

This study will harvest testicular tissue from eligible patients. Separate portions of the harvested tissue and/or cells will be 1) designated for research and 2) cryopreserved and maintained for participating patients as a resource for future elective procedures to attempt fertility restoration.

Testicular Tissue Cryopreservation for Fertility Preservation

Testicular Tissue Cryopreservation for Fertility Preservation in Patients Facing Infertility-causing Diseases or Treatment Regimens

The investigators will publish individual participant data. The investigators will also report each individual participants data back to them. Participants will be identified with unique ID numbers. No identifiable information will be shared.

A segment of testicular specimen (\~5%) will be removed and assessed for presence of spermatogonial stem cells by immunofluorescence and hematoxylin staining

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Spermatogonial Stem Cell (SSC) Transplant and Testicular Tissue Grafting	NCT04452305	Infertility, Ma... Cancer Autoimmune Diso...	Spermatogonial ...	-	University of Pittsburgh
Testicular Tissue Cryopreservation for Fertility Preservation	NCT02972801	Cancer Autoimmune Diso...	Testicular biop...	-	University of Pittsburgh
Spermatogonial Stem Cell (SSC) Transplant and Testicular Tissue Grafting	NCT04452305	Infertility, Ma... Cancer Autoimmune Diso...	Spermatogonial ...	-	University of Pittsburgh
Testicular Tissue Cryopreservation for Fertility Preservation	NCT02972801	Cancer Autoimmune Diso...	Testicular biop...	-	University of Pittsburgh

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