NCT07124871

PRP Exosomes Therapy for Erectile Dysfunction

Platelet Rich Plasma - Derived Exosomes Therapy for Erectile Dysfunction: A Feasibility Clinical Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Institute for the Study of Urological Diseases, Greece · Academic / Other
• Sex: Male
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

It will be a Single-arm, single-center, feasibility clinical trial with Primary Objective to investigate the treatment efficacy of PRP-derived exosomes injection in men with mild-moderate vasculogenic ED, as measured by the International Index of Erectile Function (IIEF). Also secondary objectives will be to study the adverse events and safety of the PRP-derived exosomes injection treatment in vasculogenic ED patients Study Centers The study will be carried out at Saint Lucas Hospital, Thessaloniki, Greece. Laboratory tests of all patients will be performed at the hospital's microbiology laboratory. PRP-derived exosomes preparation and application will take place at the Regenerative Clinic.

Conditions

• Erectile Dysfunction Due to Arterial Insufficiency

Interventions

Type	Name	Description
BIOLOGICAL	PRP-derived exosomes injection	All subjects will receive three sessions of PRP-derived exosomes injection with 21± 3 days treatment interval.The patient will be positioned supine. A ¼-inch Penrose drain will be used as a tourniquet by placing it at the base of the penis and maintaining it in place under tension by a sterile clamp. We will obtain 10 mL of PRP per patient, but one of them will be used for platelet cell count analysis. A total 9 mL of the PRP-derived exosomes will be infused steadily over a 2 minutes period - 4.5 mL each into the right and left corpus cavernosum. The infusion will be performed at this slow speed - each side over 2 minutes of infusion - to minimize injury to the exosomes and cells. Following administration, compression of the penis will be achieved with a clenched fist for 20 minutes. At 20 minutes, the tourniquet will be removed, and a compressive dressing will be placed around the penile shaft. The patient will be instructed to remove the compression bandage in 4 hours

Timeline

• Start date: 2025-06-20
• Primary completion: 2026-02-01
• Completion: 2026-05-01
• First posted: 2025-08-15
• Last updated: 2025-08-15

Locations

1 site across 1 country: Greece