Study of Stem Cell and Exosome Therapy to Restore Fertility in Men and Women Aged 20 to 50 With Testicular or Ovarian Failure Evaluating Safety and Hormonal Recovery Over 12 Months

What this Trial Is About

Researchers are evaluating the safety and effectiveness of stem cell or stem cell-derived exosome therapy for people with gonadal failure, which includes testicular failure, hypogonadism, ovarian insufficiency, and premature ovarian failure POF. The study focuses on adults aged 20 to 50 who have not responded well to usual treatments like hormone replacement therapy or assisted reproductive technologies. It aims to explore whether this regenerative treatment can restore hormone production and improve reproductive function, especially in a region where donor sperm and eggs are not allowed. Participants will receive a single injection of adipose-derived stem cells or exosomes directly into their testes or ovaries under anesthesia. The stem cells or exosomes are prepared in a specialized lab and checked for safety and quality before administration. This open-label pilot study includes 60 participants, divided equally between men and women. Follow-up visits occur at 3, 6, 9, and 12 months after treatment to track changes in hormone levels, gonadal function, and reproductive capacity. During the study, participants will have blood tests to measure hormones like testosterone and estradiol, imaging scans to assess gonadal tissue, and semen analysis for men. Researchers will monitor for any side effects or complications, including infections or immune reactions. The main outcome is the change in reproductive capacity after 12 months. Data collected will help guide future larger trials and contribute to developing new fertility treatments using regenerative medicine.

Fertility Enhancement Through Regenerative Treatment in Ovaries and Testes