Autologous stem cell transplant to try to restart sperm production in men with non-obstructive azoospermia
Official title: Intra-Testicular Transplantation of Purified Autologous None Marrow-Derived, Highly Specialized Cellular Populations, and Mesenchymal Stem Cells for Treatment of Non-Obstructive Azoospermia Male Infertility. Patients Diagnosed With Any of the Following Might Benefit: Sertoli Cell Only Syndrome (SCOS), Maturation Arrest, Post- Chemotherapy, Small Testes, Cystic Fibrosis Obstructive Azoospermia, Post-hormonal Therapy,
Run by Stem Cells Arabia · NCT02641769 · Data updated 2026-11-12
This study tests whether a patient’s own bone marrow–derived stem cells, prepared to become sperm-supporting cells, can be injected into the testis to see if sperm production can resume in men with non-obstructive azoospermia.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 21 Years to 50 Years |
| Sex | Men only |
| Enrollment | 600 (estimated) |
| Sponsor | Stem Cells Arabia Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Amman, Amman Governorate) |
| Status | Recruiting |
| Started | January 2014 |
| Main results expected | June 2030 |
| Study ends | January 2031 |
| Registry record updated | July 1, 2026 |
| Trial ID | NCT02641769 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Infertile men with confirmed non-obstructive azoospermia who have no obstructive causes and meet other specified medical criteria.
✕Probably not a fit
Individuals with irreversible testicular damage or contraindications to stem cell transplantation may not experience any fertility-related benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an open-label, single-arm, single-center phase 1/2 trial evaluating the safety and potential efficacy of autologous stem cells differentiated toward spermatogonial lineages and mesenchymal cells, delivered into the seminiferous tubules of the testes. Participants are infertile men with non-obstructive azoospermia and undergo transplantation of the stem cell preparation with up to 24 months of follow-up. Outcomes focus on testicular morphology, semen quality, endocrine markers, and evidence of spermatogenesis. The approach leverages the patient’s own cells to avoid immune rejection and preserve genetic material. The study design prioritizes feasibility and preliminary signals of benefit in a rare infertility condition.
Why it matters
Potential benefit: If successful, participants may experience improvements in testicular function and the potential appearance of sperm, which could aid future fertility efforts.
How similar studies have gone: Prior approaches in this area are preliminary; this trial explores a novel autologous stem cell strategy with limited prior clinical success but potential for signal generation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Infertile males with confirmed diagnosis of non-obstructive azoospermia (NOA) Exclusion Criteria: * Patients with Obstructive Azoospermia (OA) * Previous surgical history in Testis * Patients with infectious genital diseases * Patients with anatomical abnormalities of the genital tract * Patients with major medical problems as malignancies * Chromosomal aberration (e.g. Y microdeletion, trisomy….)
Where it's running
-
Stem Cells of Arabia
Amman, Amman Governorate, Jordan Recruiting
Study contacts
- Principal investigator: Adeeb AlZoubi, PhD — Stem Cells of Arabia
- Study coordinator: Adeeb AlZoubi, PhD
- Email: adeebalzoubi@stemcellsarabia.net
- Phone: 00962795337575
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.