Investigating the Effect of Exosome Derived From Human Fetal Umbilical Cord Mesanchymal Cells as Complimintary Treatment in Moderate to Severe Erectile Dysfunction (MSC)

NCT07319533 Phase 2 NOT_YET_RECRUITING

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.

Details

Lead sponsor	Labbafinejad Medical Center
Phase	Phase 2
Status	NOT_YET_RECRUITING
Enrolment	70
Start date	2026-01
Completion	2027-01

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

Interventions

• exosomes derived from human umbilical cord mesenchymal stem cells
• Normal (0.9%) saline

Primary outcomes

• IIEF-5 score — week 0, 7, 13, 25, 49
  Erectile dysfunction of the patients during the study will be assessed by IIEF-5 questionnaire. It will done in a interview with the patients.

Countries

Iran