PRP Exosomes Therapy for Erectile Dysfunction

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

NCT07124871•Institute for the Study of Urological Diseases, Greece

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.

Eligibility

Age

40 - 70 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Consent to participate.
•Age 40-70 years.
•Sexually active in a stable, heterosexual relationship of more than three months duration.
•Presence of ED for at least 6 months.
•IIEF-ED: 17-25 at visit 2. The IIEF classifies the severity of ED into five categories stratified by score: No ED: 26-30, Mild ED: 22-25, Mild to moderate ED: 17-21, Moderate ED: 11-16 and Severe ED: 6-10.
•Patients will be PDE5i users for at least 6 months and report some/good response to PDE5i in the last month before screening (at visit 1
•Agree to suspend all ED therapy for the duration of the study.
•Agree to attempt sexual intercourse at least 4 times every 3 weeks for the duration of the study without being under the influence of alcohol or recreational drugs.
•Agree to document the outcome using IIEF questionnaire during every visit and the Sexual Encounter Profile (SEP) diary, as needed (months 1 and 3 post treatment).

Exclusion Criteria

•Previous major pelvic surgery or pelvic trauma that could impact EF, such as radical prostatectomy, radical cystectomy, or rectal surgery. 19
•Patients with previous transurethral resection of the prostate (TURP) surgery without sequelae of iatrogenic ED may be included.
•Previous penile surgery of any kind except circumcision and condyloma removal, such as penile lengthening, penile cancer surgery, penile plication, and grafting.
•Previous history of priapism or penile fracture
•Previous radiation therapy to the pelvis.
•Abnormal morning serum testosterone level, defined as a value lower than 300 ng/dL (indicative of untreated hypogonadism) or greater than1197 ng/dL.
•Current or previous hormone use, other than prescribed testosterone, clomiphene or thyroid medication. Subjects with prior or current use of hormonal treatment for prostate cancer are also excluded.
•Psychogenic ED.
•Peyronie's Disease or penile curvature that negatively influences sexual activity.
•Anatomical or neurological abnormalities in the treatment area.
+11 more criteria

Locations (1)

St Lukes Hospital

Thessaloniki, Greece

Key Dates

Start Date

June 20, 2025

Primary Completion Date

February 1, 2026

Completion Date

May 1, 2026

Last Updated

August 15, 2025

Enrollment

ESTIMATED participants

Conditions

Erectile Dysfunction Due to Arterial Insufficiency

Interventions

PRP-derived exosomes injection

BIOLOGICAL

Contacts

Dimitrios Hatzichristou, Professor

CONTACT

+306944541516 d.hatzichristou@gmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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