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Stem cell therapy for erectile dysfunction.

Clinics inject cells, exosomes or PRP into the penis to restore erections. The single-arm studies looked encouraging, but the first proper placebo-controlled trial, in 70 men, found no difference at a year.[1]

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Written by Eli McGarvie.

Clinics that treat erectile dysfunction.

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All 7 clinics
ClinicConditionsTreatmentsPrice from
Longevity Medical InstituteSan José del Cabo, Mexico EDKneeShoulderHip MesenchymalExosomesIVInjections USD 1,425 Regeneris TherapyCancún, Mexico EDKneeBack painHair loss MesenchymalExosomesIVInjections Not disclosed Dream Body ClinicBucerías, Mexico EDKneeHipShoulder MesenchymalUmbilical cordIVInjections USD 1,750 BioGenesis Regenerative CenterPanama City, Panama EDArthritisMSDiabetes Umbilical cordMesenchymalExosomesIV USD 12,000 BioXcelleratorMedellín, Colombia EDAutismMSArthritis Umbilical cordMesenchymalExosomesIV Not disclosed Stem Cells ColombiaMedellín, Colombia EDKneeShoulderHip Umbilical cordMesenchymalExosomesInjections USD 1,399

What to expect

The procedure

After a numbing cream, a few small injections into the shaft. Men who had it describe it as a minor event with no downtime.[2] Trials used cells from your own fat or bone marrow, which means a harvest first.[3][4]

How many sessions

Cell trials used one injection or two in a row; a PRP trial used three, 15 days apart, and none compared schedules.[5][6][7] Clinics and trial protocols often add a vacuum pump afterwards.[2]

When it works, and how long it lasts

In the only study with two years of data, scores improved up to 12 months and had fallen below where they started by 24 months.[8] Men who paid for it mostly said it did nothing, and where a benefit appeared it usually wore off.[2]

Who it suits, and who it doesn't

In early studies, men who were incontinent after prostate surgery, or had erection problems before it, did not respond.[5][3] In the controlled trial, no group did better than placebo.[1]

Risks

Bruising, redness and short-lived pain at the injection site. No serious side effect has been put down to the cells in any published trial.[3][9][1]

No difference from placebo in the controlled trial

Does it work? Not against a placebo. The Danish team behind the early studies ran a proper trial in 2026 and found no difference.[1]

No differencein questionnaire scores, erection hardness or overnight measurement at 12 monthsDouble-blind placebo-controlled trial, 70 men after prostate surgery[1]
8 of 15men in the same team's earlier study without a placebo group: the "53%" figure clinics quoteUncontrolled study[3]
20% to 25%of men recover erections after prostate surgery without any treatment, which uncontrolled figures cannot separate outEuropean Association of Urology guideline[10]
0 of 13men who paid for a penile stem cell injection and reported online described a lasting cure. 7 said it did nothing.Our review of patient accounts on Reddit and forums[2]

Where it is allowed

United States. No cell product is approved for erectile dysfunction.[11] The FDA has warned companies marketing cord products for erectile and sexual dysfunction.[12][13]

Malaysia. Every cell product injected for erectile dysfunction must be registered first.[14]

Mexico. COFEPRIS has said stem cell treatments lack authorisation.[15]

Specialists. The American Urological Association calls stem cell injection investigational. The Sexual Medicine Society of North America says it should be kept to clinical trials.[16][17]

Common questions

Is the P-shot a stem cell treatment?

No. The P-shot is PRP, made from your own blood, and contains no stem cells. The American Urological Association classes it as experimental.[7][16]

Are exosomes an option?

No completed human trial of exosomes for erectile dysfunction was found, and no exosome product is approved.[18][19]

Does it work for Peyronie's disease?

In the only trial that measured curvature objectively, it did not change.[20]

Questions to ask a clinic

  1. Is this stem cells, exosomes or PRP? What exactly is in the syringe?
  2. If it is my own cells, how are they harvested and counted?
  3. Is a urologist involved in my care?
  4. What else will you recommend: IV drips, shockwave, more injections? Why each one?
  5. How long did the effect last in your patients?
  6. What do you suggest if it does not work?

Sources

20 references
  1. Hansen ST, et al. A Randomized Double-blind, Placebo-controlled Trial of Adipose-derived Regenerative Cells Injected into Corpora Cavernosum Following Radical Prostatectomy. European Urology Focus, 2026. Link
  2. StemFinder review of first-hand patient accounts on Reddit and patient forums, 2026. Method
  3. Haahr MK, et al. A 12-Month Follow-up After a Single Intracavernous Injection of Autologous Adipose-Derived Regenerative Cells in Patients with Erectile Dysfunction Following Radical Prostatectomy: An Open-Label Phase I Clinical Trial. Urology, 2018. Link
  4. Al Demour S, et al. Safety and Efficacy of 2 Intracavernous Injections of Allogeneic Wharton's Jelly-Derived Mesenchymal Stem Cells in Diabetic Patients with Erectile Dysfunction: Phase 1/2 Clinical Trial. Urologia Internationalis, 2021. Link
  5. Haahr MK, et al. Safety and Potential Effect of a Single Intracavernous Injection of Autologous Adipose-Derived Regenerative Cells in Patients with Erectile Dysfunction Following Radical Prostatectomy: An Open-Label Phase I Clinical Trial. EBioMedicine, 2016. Link
  6. Al Demour S, et al. Safety and Potential Therapeutic Effect of Two Intracavernous Autologous Bone Marrow Derived Mesenchymal Stem Cells injections in Diabetic Patients with Erectile Dysfunction: An Open Label Phase I Clinical Trial. Urologia Internationalis, 2018. Link
  7. Schirmann A, et al. Pilot study of intra-cavernous injections of platelet-rich plasma (P-shot®) in the treatment of vascular erectile dysfunction. Progres En Urologie, 2022. Link
  8. Al Demour S, et al. Stem cell therapy in diabetic men with erectile dysfunction: a 24-month follow-up of safety and efficacy of two intracavernous autologous bone marrow derived mesenchymal stem cells injections, an open label phase 2 clinical trial. Basic and Clinical Andrology, 2024. Link
  9. Senel S, et al. Stem cell therapy for erectile dysfunction: promise or reality? - a systematic review and meta-analysis of clinical trials. BMC urology, 2025. Link
  10. Salonia A, et al. EAU Guidelines on Sexual and Reproductive Health (limited update March 2025). European Association of Urology, 2025. Link
  11. U.S. Food and Drug Administration. Approved Cellular and Gene Therapy Products. U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, 2026. Link
  12. U.S. Food and Drug Administration, Center for Biologics Evaluation and Research. Warning Letter: R3 Medical Companies (Bello Bio, LLC and Regen Suppliers, LLC), 726330, 08/14/2026. U.S. Food and Drug Administration, 2026. Link
  13. U.S. Food and Drug Administration, Center for Biologics Evaluation and Research. Warning Letter: Innate Healthcare Institute, 695592, 08/15/2025. U.S. Food and Drug Administration, 2025. Link
  14. National Pharmaceutical Regulatory Agency, Ministry of Health Malaysia. Guidance Document and Guidelines for Registration of Cell and Gene Therapy Products (CGTPs) in Malaysia, Second Edition (September 2025). 2025. Link
  15. Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS). La COFEPRIS suspendió clínica del D.F. que ofrecía tratamientos con Células Madre sin aval científico. Gobierno de México, COFEPRIS (press release), 2015. Link
  16. Burnett AL, et al. Erectile Dysfunction: AUA Guideline (guideline statements 23, 24 and 25). American Urological Association, 2018. Link
  17. Liu JL, et al. Restorative Therapies for Erectile Dysfunction: Position Statement From the Sexual Medicine Society of North America (SMSNA). Sexual Medicine, 2021. Link
  18. ClinicalTrials.gov. ClinicalTrials.gov search: condition erectile dysfunction, intervention stem cell (and related searches for mesenchymal and for Peyronie's disease). U.S. National Library of Medicine, 2026. Link
  19. U.S. Food and Drug Administration. Public Safety Notification on Exosome Products. 2019. Link
  20. Wiborg MH, et al. Treatment with Autologous Adipose-derived Regenerative Cells for Peyronie's Disease in Men: The Straight @head Pilot Study. European Urology Open Science, 2025. Link

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