How strong is the evidence for stem-cell therapy in Erectile Dysfunction?
ClinicalTrials.gov registrations alone cannot establish how strong the evidence is. Registry activity is active but still early, with limited late-phase registration: the registry holds 35 records, 12 completed, 2 at Phase 3 or 4, and 4 stopped early (11%). MSC-specific work accounts for 23 of those records. These counts describe research activity and maturity, not benefit, safety or certainty. Snapshot 2026-08-29.
What counts as a real result in Erectile Dysfunction
A credible result changes a validated erectile-function score against sham at six to twelve months, with objective flow measures where possible. Self-reported improvement in an unblinded study, in men who paid several thousand euros, is the definition of a low-information endpoint.
What we can say from registrations alone
- Volume: 35 registered studies since 2010.
- Maturity: 2 confirmatory-phase records.
- Delivery: 12 completed; 4 terminated, withdrawn or suspended.
- Scale: median planned enrolment 30 participants, largest 5,000.
The completed studies
Completed does not mean published, and published does not mean positive. These are the finished records — the starting point for checking whether results ever appeared.
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| 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 |
| NCT04594850 — Clinical Trial to Evaluate Efficacy and Safety of of Autologous Mesenchymal Stem Cells (MSC) Injected Intracavernously | Phase 2 | Completed | 54 | Pharmicell Co., Ltd. | 2020-10-19 |
| NCT06600893 — Sham-Controlled Prospective Study Characterizing Erectile Tissue Ultrasound Changes Resulting From Penile LiSWT | n/a | Completed | 35 | San Diego Sexual Medicine | 2019-08-05 |
| NCT04771442 — Stem Cell Treatment of Peyronie´s Disease. | Phase 1 | Completed | 22 | Esbjerg Hospital - University Hospital of Southern Denmark | 2022-09-09 |
| NCT01089387 — Intracavernous Bone Marrow Stem-cell Injection for Post Prostatectomy Erectile Dysfunction | Phase 1, Phase 2 | Completed | 18 | Institut National de la Santé Et de la Recherche Médicale, F | 2010-05 |
| NCT07245875 — Umbilical Cord Mesenchymal Stem Cell Secretome Administration in Severe Erectile Dysfunction Non-responsive to Sildenafil | n/a | Completed | 12 | Indonesia University | 2024-04-12 |
What registrations cannot tell you
Whether results were positive. Whether they were published at all — a large share of registered studies never report outcomes, which biases what the literature appears to show. And whether the product a commercial clinic sells resembles the product studied: cell source, dose, processing and delivery route vary enormously between a registered protocol and an off-protocol injection.
How to use this when someone is selling you a treatment
Ask which specific registered study supports the offer, then compare its intervention description with your quote. If the answer is a general gesture at "Erectile Dysfunction research", you are being sold the field's activity rather than evidence about the product. The Provider Question Builder turns that gap into questions.
Frequently asked
How strong is the evidence for stem-cell therapy in Erectile Dysfunction?
ClinicalTrials.gov registrations alone cannot establish how strong the evidence is. Registry activity is active but still early, with limited late-phase registration: 35 registered records, 2 at Phase 3/4 and 4 stopped early (2026-08-29).
Has any stem-cell product been approved for this condition?
Approval is product-and-indication specific and changes over time; check the FDA, EMA or your national regulator directly rather than relying on a clinic's summary.
Why do clinics cite hundreds of studies?
Volume is the cheapest form of credibility. Ask instead for the controlled studies of the specific product, and read what outcome they measured.
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