What research stage is stem-cell therapy for Erectile Dysfunction at?
2 of 35 registered records carry a Phase 3 or Phase 4 label. The rest sit at earlier phases or carry no phase label at all. Snapshot 2026-08-29.
Phase distribution
| Phase label | Records | Share |
|---|---|---|
| Phase 1 | 22 | 48% |
| Phase 2 | 15 | 33% |
| Not applicable | 7 | 15% |
| Phase 3 | 2 | 4% |
What the phase mix means for Erectile Dysfunction
Most registrations are early-phase and small, with short follow-up. That is a poor fit for a condition where placebo response on questionnaire scores is large and well documented across decades of drug trials.
The later-phase studies themselves
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT07480161 — Mesenchymal Stem Cell and Exosome Therapy for Diabetic Erectile Dysfunction | Phase 2, Phase 3 | Recruiting | 90 | Ankara City Hospital Bilkent | 2025-12-29 |
| NCT04972890 — The Outcomes of Intracavernosal Umbilical Cord Mesenchymal Stem Cells Implantation in Patients With Diabetic Erectile Dysfunction | Phase 2, Phase 3 | Unknown | 12 | Indonesia University | 2020-10-27 |
How to read phase labels
Early phases exist to find harm and set a dose. They are not built to detect benefit, and they routinely produce encouraging-looking numbers that later trials fail to reproduce. Only a confirmatory design with a comparison arm can separate the intervention from everything else happening to a patient.
Median planned enrolment across sampled studies here is 30 participants. Small single-arm studies can flag safety problems; they cannot separate a treatment effect from natural fluctuation, placebo response or regression to the mean.
The largest studies by planned enrolment
Size is a crude proxy for what a study can detect, but it separates a serious attempt from a case series presented as evidence.
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT04684602 — Mesenchymal Stem Cells for the Treatment of Various Chronic and Acute Conditions | Phase 1, Phase 2 | Recruiting | 5,000 | Thomas Advanced Medical LLC | 2020-07-09 |
| NCT03899298 — Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions | Phase 1 | Not Yet Recruiting | 5,000 | R3 Stem Cell | 2019-09-01 |
| NCT01953523 — Safety and Clinical Outcomes Study: SVF Deployment for Orthopedic, Neurologic, Urologic, and Cardio-pulmonary Conditions | n/a | Completed | 3,000 | Elliot Lander | 2013-09-02 |
| NCT07544537 — A Prospective Comparative Study of Autologous Bone Marrow-Derived and Adipose Tissue-Derived Mesenchymal Stem Cells Versus Platelet-Rich Plasma and St | Phase 2 | Active Not Recruiting | 100 | National Scientific Medical Center, Kazakhstan | 2024-09-09 |
| NCT07480161 — Mesenchymal Stem Cell and Exosome Therapy for Diabetic Erectile Dysfunction | Phase 2, Phase 3 | Recruiting | 90 | Ankara City Hospital Bilkent | 2025-12-29 |
Frequently asked
What research stage is stem-cell therapy for Erectile Dysfunction at?
2 of 35 records are labelled Phase 3 or 4 (2026-08-29).
Is a Phase 3 trial proof that it works?
No — it is a design capable of testing that question. Proof depends on the reported result, replication, and whether the outcome measured matters to patients.
Why do so many records have no phase?
Observational studies and some cell-therapy protocols are registered without a phase label. It is a registry field, not a quality rating.
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.
More on this condition
- Erectile Dysfunction: cell-therapy evidence and registered trials
- How much does stem cell therapy for Erectile Dysfunction cost? (2026)
- Erectile Dysfunction stem cell therapy — your questions answered (2026)
- Erectile Dysfunction: cell-therapy evidence by therapy class
- MSC vs PRP for Erectile Dysfunction: what the registries show