Could stem cells restore erectile function in diabetic men?
NCT ID NCT07480161
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether injecting stem cells or their exosomes into the penis can improve erectile function in men with diabetes who haven't been helped by standard treatments. Ninety men will receive either a placebo, stem cells, or exosomes in a single injection. Researchers will track changes in erectile function and blood flow over 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- umbilical cord-derived mesenchymal stem cells and their exosomes
- What this could lead to
- If successful, this could offer a new regenerative treatment option for men with diabetic erectile dysfunction who do not respond to current medications.
- What could go wrong
- This is a mid-stage trial with only 90 participants, so results may not apply to everyone. There are also risks from the injection procedure, such as pain, bruising, or infection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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25 to 75 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Ankara Bilkent City Hospital
RECRUITINGAnkara, Ankara, 06800, Turkey (Türkiye)