Actively Recruiting

Phase Not Applicable
MALE
ID04452305

Spermatogonial Stem Cell Transplant and Testicular Tissue Grafting to Restore Fertility in Males

Led by University of Pittsburgh · Updated on 2026-04-22

10

Participants Needed

1

Research Sites

22 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the safety and feasibility of spermatogonial stem cell transplantation and testicular tissue grafting to restore fertility in male participants who have previously frozen testicular tissue before undergoing treatments that risk infertility. The study focuses on adult men affected by infertility due to loss or damage of spermatogonial stem cells caused by diseases or medical therapies such as chemotherapy or radiation. It addresses a critical need for patients who could not preserve semen samples prior to treatment, especially prepubertal males. Participants will receive one of two experimental procedures: autologous transplantation of testicular cells, including spermatogonial stem cells, using ultrasound-guided rete testis injection, or autologous grafting of intact testicular tissue pieces under the skin of the scrotum. Both methods use the participant's own previously cryopreserved testicular tissue or cells. These procedures are designed to stimulate sperm production and are monitored for safety and effectiveness. During the study, participants will be assessed for the return of sperm production between 3 months and 1 year after treatment. Researchers will also monitor for any surgical complications within 3 months and track cancer recurrence over a 5-year period. Participant involvement includes medical evaluations, clearance from hematologists or oncologists, and follow-up visits to measure outcomes related to fertility restoration and safety. The total duration and follow-up extend up to 5 years, ensuring thorough monitoring of long-term effects.

CONDITIONS

Brief Title

Spermatogonial Stem Cell (SSC) Transplant and Testicular Tissue Grafting

Who Can Participate

MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male participant at least in Tanner stage 3
  • Previously cryopreserved and stored testicular tissue or cells available for autologous transplantation and grafting
  • Healthy enough to undergo anesthesia
  • Written clearance from hematologist or oncologist confirming completion of primary treatment and suitability for autologous stem cell transplant
Not Eligible

You will not qualify if you...

  • High risk for surgical complications
  • History of leukemia, lymphoma, testicular cancer, or cancer likely involving testicles at time of tissue collection
  • Psychological, psychiatric, or other conditions preventing fully informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Up to 1 year

Participants undergo spermatogonial stem cell transplant and testicular tissue grafting to restore sperm production.

1 baseline visit and multiple follow-up visits over 1 year

Trial Site Locations

Total: 1 location

1

Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

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Research Team

J

Jennifer L Anglin

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Ultrasound-Guided Rete Testis Approach to Sperm Aspiration and Spermatogonial Stem Cell Transplantation in Patients with Azoospermia.

Amanda Colvin Zielen, Karen A Peters, Gunapala Shetty...

https://pubmed.ncbi.nlm.nih.gov/40365444