Clinical Trial Investigating the Effect of Exosomes as a Complementary Treatment in Severe to Moderate 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.

NCT Number	NCT07319533
Lead Sponsor	Labbafinejad Medical Center
Conditions	Erectile Dysfunction, Erectile Dysfunction Associated With Type 2 Diabetes Mellitus, Erectile Dysfunction Due to Arterial Disease, Erectile Dysfunction Due to Arterial Insufficiency, Erectile Dysfunction Due to General Medical Condition, Erectile Dysfunction Due to Neuropathy
Enrollment	70 participants
Start Date	2026-01
Primary Completion	2027-01 (estimated)
Study Completion	2027-01 (estimated)
Updated on ClinicalTrials.gov	2026-01-06