NCT07319533Not yet recruitingPhase 2
Clinical Trial Investigating the Effect of Exosomes as a Complementary Treatment in Severe to Moderate Erectile Dysfunction
Investigating the Effect of Exosome Derived From Human Fetal Umbilical Cord Mesanchymal Cells as Complimintary Treatment in Moderate to Severe Erectile Dysfunction
Source: ClinicalTrials.gov · Last updated 6 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 21 Dec 2025
- Start date
- Jan 2026
- Primary completion date
- Jan 2027
- Lead sponsor
- Labbafinejad Medical Center
- Diseases
- Type 2 diabetes
- NCT number
- NCT07319533
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 70
- From Jan 2026 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Who the study is looking for
- Moderate or severe erectile dysfunction (according to IIEF-5) Non-satisfactory response to other treatments Generally Healthy males Not having severe past medical history
Age in the registry: 18 years to 70 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shahid Labbafinejad Hospital Coordinator of this site? Confirm its status | Tehran | Iran | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.