Male Infertility: cell-therapy evidence by therapy class
Across every stem-cell intervention, ClinicalTrials.gov holds 15 registered records for Male Infertility — 4 recruiting, 0 at Phase 3 or 4, in 10 countries. Snapshot 2026-08-29.
The condition, and why cells are proposed
Non-obstructive azoospermia and severe spermatogenic failure are the registry targets, where the proposed mechanism is restoring or supporting spermatogonial function. This is early experimental biology, and the outcome — a live birth — is unusually unambiguous, which makes weak claims easy to test in principle.
Therapy classes side by side
| Therapy class | Registered | Recruiting | Phase 3/4 | Countries |
|---|---|---|---|---|
| MSC | 4 | 1 | 0 | 3 |
| HSCT | 2 | 2 | 0 | 2 |
| exosomes | 1 | 1 | 0 | 1 |
| PRP | 2 | 1 | 1 | 2 |
Counts come from separate registry queries per class; a study testing two interventions can appear in more than one row, so rows do not sum to the all-interventions total.
Geography of the research
Egypt accounts for about 27% of country mentions among sampled studies; 10 countries host at least one site.
| Country | Studies with a site there |
|---|---|
| Egypt | 4 |
| United States | 3 |
| Israel | 1 |
| Russia | 1 |
| United Arab Emirates | 1 |
| Brazil | 1 |
| Spain | 1 |
| Jordan | 1 |
The largest registered studies
Sorted by planned enrolment — size is not quality, but a 300-participant trial can answer questions a 12-participant series cannot.
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT02641769 — Intra-Testicular Transplantation of Autologous Stem Cells for Treatment of Non-Obstructive Azoospermia Male Infertility. | Phase 1, Phase 2 | Recruiting | 600 | Stem Cells Arabia | 2014-01 |
| NCT02756923 — Regulation of Stem Spermatogonia in the Mature Testis | n/a | Completed | 142 | Weill Medical College of Cornell University | 2012-04 |
| NCT02025270 — MSCs For Treatment of Azoospermic Patients | Phase 1, Phase 2 | Completed | 100 | Al-Azhar University | 2012-10-15 |
| NCT06841861 — Spermatogonial Differentiation Via Testicular Organoid | Phase 1, Phase 2 | Recruiting | 100 | CellARTs Inc. | 2024-03-28 |
| NCT02380755 — Clomiphene Citrate for the Treatment of Obesity Related Male Hypogonadism | Phase 2 | Completed | 78 | University of Sao Paulo | 2015-04 |
| NCT01375062 — Obtaining Undifferentiated Cells From Testis Biopsy | n/a | Completed | 65 | Igenomix | 2009-05 |
Most recently registered
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT07140549 — Survey of Patients Who Received Fertility Preservation Counseling and Underwent Testicular Tissue Cryopreservation Prior to Gonadotoxic Treatment Duri | n/a | Enrolling By Invitation | n/a | Cliniques universitaires Saint-Luc- Université Catholique de | 2025-07-01 |
| NCT06841328 — Fertility Enhancement Through Regenerative Treatment in Ovaries and Testes | n/a | Recruiting | n/a | Jumeirah American Clinic | 2025-04-08 |
| NCT05158114 — Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Testicular Injury and Oligospermia | n/a | Withdrawn | n/a | The Foundation for Orthopaedics and Regenerative Medicine | 2025-04-03 |
| NCT06841861 — Spermatogonial Differentiation Via Testicular Organoid | n/a | Recruiting | n/a | CellARTs Inc. | 2024-03-28 |
| NCT04452305 — Spermatogonial Stem Cell (SSC) Transplant and Testicular Tissue Grafting | n/a | Recruiting | n/a | University of Pittsburgh | 2023-11-10 |
Reading this honestly
None of these numbers say the therapy works. They say how much organised research exists and how far along it is; effect sizes live in published results, not registry entries. For Male Infertility specifically, the practical question is which registered study — if any — matches the product a provider is offering, and what its outcome measures actually are.
Frequently asked
How many stem-cell trials exist for Male Infertility?
15 registered records mention a stem-cell intervention for this condition (2026-08-29 snapshot), of which 4 were recruiting.
Which therapy class is furthest along for Male Infertility?
Ranked by Phase 3/4 records: PRP (1), MSC (0), HSCT (0), exosomes (0).
Does a recruiting trial mean I can be treated?
No. Trials have eligibility criteria, and joining one is not the same as buying a treatment. Paying a clinic for an unproven intervention outside a registered study gives you neither the protections nor the data collection of a trial.
Registry and literature counts retrieved 2026-08-29 (ClinicalTrials.gov API v2; PubMed E-utilities). Registration or publication volume measures research activity, not effectiveness or approval. Educational information — not medical advice; verify product, indication, legal pathway and evidence with an independent qualified physician. Page generated 2026-08-29. See our editorial standards.
Download the query data
Query totals are full API matches; status, phase and country counts describe the first up to 400 returned records per query. Query classes overlap and must not be summed as unique trials. Counts are not treatment outcomes. Snapshot: 2026-08-29. Methods and field definitions.