This study investigates the safety and efficacy of stem cell or stem cell-derived exosome therapy for gonadal failure, including testicular failure, hypogonadism, ovarian insufficiency, and premature ovarian failure (POF). Conducted at First IVF Clinic, Dubai, it will include 60 participants (30 males, 30 females) aged 20-50 years who have not responded to conventional treatments such as HRT, TRT, or ART.
Participants will receive intra-gonadal (testicular or ovarian) injections of stem cells or exosomes, with follow-ups at 3, 6, 9, and 12 months to monitor hormonal changes, gonadal function, and potential adverse effects. The study aims to determine whether regenerative therapy can restore hormone production, enhance reproductive function, and regenerate gonadal tissue, providing a novel, culturally appropriate fertility treatment in the UAE, where donor sperm and eggs are not permitted.
By bridging the gap between preclinical research and clinical application, this study could offer new hope to individuals with gonadal failure, advancing the field of regenerative reproductive medicine.
Male patients aged 20 to 50 years.
Diagnosed with testicular failure (low testosterone) or hypogonadism (impaired gonadal function), or azoospermia (no sperm in ejaculate)
Suboptimal response to conventional treatments, such as testosterone replacement therapy (TRT) or fertility-enhancing medications (Clomiphene citrate or anastrozole).
General good health without significant contraindications to stem cell or stem cell-derived exosome therapy.
Severe comorbid conditions, such as advanced cardiovascular disease, renal failure, or uncontrolled diabetes.
Active malignancies or history of cancer within the past 5 years.
Active infections or systemic inflammatory conditions.
History of testicular surgery or trauma that could interfere with the study outcomes.
The study population will consist of adult male and female patients aged 20 to 50 years who are diagnosed with testicular or ovarian failure and are seeking treatment at First IVF and Day Surgery Center. Participants will be recruited from the pool of patients under the care of the PI or the co-Is. Eligibility will include individuals with confirmed testicular or ovarian failure based on clinical, hormonal, and imaging criteria who have not responded adequately to conventional treatments such as hormone therapy (HT).
Cohort
Prospective
Stem cells
Procedure/SurgeryThe administration of stem cell or stem cell-derived exosome therapy as a regenerative treatment for gonadal failure in both men and women. The intervention involves a single intra-gonadal injection (testicular or ovarian) of adipose-derived stem cells (ADSCs) or exosomes.
Change in reproductive capacity
We will evaluate hormonal changes (testosterone, estradiol, FSH, AMH) and sperm parameters
Gonadal Function
Evaluate functional outcomes such as surgical sperm retrieval success and ovarian follicular activity in women (via antral follicle count and egg retrieval success)
Adverse Effects
Document any adverse events or complications related to stem cell or exosome therapy, such as fibrosis, infection, or immune reactions.
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