Umbilical cord stem cell and exosome injections for diabetic erectile dysfunction
Official title: Safety and Efficiacy of Mesenchymal Stem Cell and Exosome Therapy for Diabetic Erectile Dysfunction: A Randomized Placebo-Controlled Clinical Trial
Run by Ankara City Hospital Bilkent · NCT07480161 · Data updated 2026-11-12
This will test whether injections of umbilical cord–derived mesenchymal stem cells or their exosomes into the penis can improve erections in men aged 25–75 with diabetes who haven't responded to standard ED medicines.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 25 Years to 75 Years |
| Sex | Men only |
| Enrollment | 90 (estimated) |
| Sponsor | Ankara City Hospital Bilkent Academic / other |
| Locations | 1 site (Ankara, Ankara) |
| Status | Recruiting |
| Started | December 29, 2025 |
| Main results expected | December 29, 2027 |
| Study ends | December 29, 2028 |
| Registry record updated | March 18, 2026 |
| Trial ID | NCT07480161 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Men aged 25 to 75 with diabetic erectile dysfunction for at least 6 months, diabetes for at least 5 years, and inadequate response to PDE-5 inhibitors or intracavernosal prostaglandin E1 are ideal candidates.
✕Probably not a fit
Patients with penile anatomical deformities, active penile infection or skin lesions, uncontrolled diabetes, prior penile prosthesis or pelvic surgery, untreated hypogonadism, unstable cardiovascular disease, malignancy, autoimmune disease, or on immunosuppressive therapy are unlikely to benefit or may be excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, randomized, placebo-controlled trial comparing intracavernosal injections of umbilical cord–derived mesenchymal stem cells (MSCs), MSC-derived exosomes, and placebo in men with diabetic erectile dysfunction refractory to standard therapies. Primary efficacy outcomes include changes in International Index of Erectile Function-5 (IIEF-5) and Erectile Hardness Score (EHS), with penile hemodynamics measured by Doppler ultrasound (PSV, EDV, RI) as secondary outcomes. Safety and treatment-related adverse events will be monitored throughout the study period. Participants are men aged 25–75 with at least 6 months of ED and at least 5 years of diabetes who have shown inadequate response to PDE-5 inhibitors or intracavernosal prostaglandin.
Why it matters
Potential benefit: If successful, these regenerative injections could restore vascular and nerve function in the penis and offer a new option for men with diabetes who do not respond to current ED medications.
How similar studies have gone: Small early-phase clinical trials and preclinical studies of stem cell therapies for diabetic ED have shown promising signals, but larger randomized data are limited and exosome therapy remains largely experimental.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male patients aged 25 to 75 years * Diagnosis of erectile dysfunction for at least 6 months * Type 1 or Type 2 diabetes mellitus for at least 5 years * Inadequate response to medical treatment, including phosphodiesterase type-5 (PDE-5) inhibitors and/or intracavernosal prostaglandin E1 therapy * Candidates for penile prosthesis implantation due to treatment-resistant erectile dysfunction * Ability and willingness to provide written informed consent Exclusion Criteria: * Penile anatomical deformities * Active infection or skin lesion on the penis * Bleeding disorders or coagulation abnormalities * Previous penile prosthesis implantation, penile vascular surgery, or pelvic surgery * Untreated hypogonadism * Unstable cardiovascular disease * History of malignancy * Autoimmune disease * Use of immunosuppressive therapy * Presence of systemic or local infection * Uncontrolled diabetes mellitus
Where it's running
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Ankara Bilkent City Hospital
Ankara, Ankara, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Samet Senel, MD, Associate Professor
- Email: samet_senel_umt@hotmail.com
- Phone: +90 537 880 22 85
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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.