Spermatogonial Stem Cell (SSC) Transplant and Testicular Tissue Grafting

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-10

Study Completion Date

2028-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance

NCT07278362

Prostate Cancer Hypogonadism, Male

NOT_YET_RECRUITING PHASE4

Does Testosterone Improve Function in Hypogonadal Older Men

NCT00304213

Hypogonadism

WITHDRAWN PHASE4

Does Testosterone Therapy Improve Patient-Reported Outcomes in Age-Related Testosterone Deficient Patients Undergoing Total Hip Replacement: A Randomized-Controlled Trial

NCT05722301

Arthroplasty, Replacement, Hip

WITHDRAWN PHASE3

Perioperative Testosterone Replacement Therapy for the Improvement of Post-Operative Outcomes in Patients With Low Testosterone

NCT04731376

Hypogonadism Malignant Urinary System Neoplasm Urinary System Disorder +1 more

RECRUITING PHASE1

A Multicenter Extension Trial to Evaluate the Safety of Testosterone Gel

NCT01703741

Adult Male Hypogonadism

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infertility, Male Cancer Autoimmune Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Spermatogonial Stem Cell Transplant & Testicular Tissue Graft

Stem cell transplantation Testicular tissue grafting

Group Type EXPERIMENTAL

Spermatogonial Stem Cell Transplant and Testicular Tissue Grafting

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Spermatogonial Stem Cell Transplant and Testicular Tissue Grafting

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Eligible Sex

MALE

Accepts Healthy Volunteers

No