Exosomes from umbilical cord stem cells added to care for erectile dysfunction
Tests exosome injections against saline in men with moderate to severe erectile dysfunction.
Plain-language title generated from the registry record
Registry title: Clinical Trial Investigating the Effect of Exosomes as a Complementary Treatment in Severe to Moderate Erectile Dysfunction
Key facts
- Where
- Tehran, IranSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07319533, who can take part
Where in Iran
- Shahid Labbafinejad HospitalTehran, IranNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Labbafinejad Medical Center
- Trial code
- NCT07319533
- Record updated
- 6 January 2026
- Original description
The goal of this clinical trial is to Investigate the Effect of Injection of MSC-Derived Exosome on Patients with Erectile Dysfunction in overall healthy males, aged 18-70, with-out any severe active medical condition, with moderate to severe erectile dysfunction based on IIEF-5, and non-satisfactory response to other treatments (5PDEI). The main question it aims to answer is:Read full original descriptionShow less
Investigating the Effect of Exosome Derived From Human Fetal Umbilical Cord Mesanchymal Cells as Complimintary Treatment in Moderate to Severe Erectile Dysfunction
The goal of this clinical trial is to Investigate the Effect of Injection of MSC-Derived Exosome on Patients with Erectile Dysfunction in overall healthy males, aged 18-70, with-out any severe active medical condition, with moderate to severe erectile dysfunction based on IIEF-5, and non-satisfactory response to other treatments (5PDEI). The main question it aims to answer is:
• Is MSC-derived exosome safe and effective in treating patients with ED by improving IIEF-5 score?
If there is a comparison group: Researchers will compare the intervention group (Exosome receiving group) with control group (placebo receiving group) to see if exosomes are safe and effective in treating male adult patients with moderate-sever ED.
Participants will receive six weekly injections of normal saline or exosome (based on group), and will undergo necessarily follow up, and examinations and observation.
Inclusion: Moderate or severe erectile dysfunction (according to IIEF-5) Non-satisfactory response to other treatments Generally Healthy males Not having severe past medical history.
Exclusion: Known allergy or history of hyperactivity to biological substances Peyronie's plaque Existing medical condition (severe or uncontrolled) Use of psychiatric medication Use of thyroid medication Hyopgonadism Hypergonadism Cancer History of prostatectomy Prostitis Autoimmune disease Recent trauma or surgery Ongoing systemic infection Skin lesion or infection at the site of injection.