RecruitingPhase 2

PRP Exosomes Therapy for Erectile Dysfunction

Greece30 participantsStarted 2025-06-20

Plain-language 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.

Who can participate

Age range40 Years – 70 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. * …

What they're measuring

The % of patients in each group who attain Minimal Clinically Important Difference (MCID) in the International Index for Erectile Function- Erectile Function (IIEF-EF) domain

Timeframe: From baseline to 12 weeks after final treatment

Trial details

NCT IDNCT07124871

SponsorInstitute for the Study of Urological Diseases, Greece

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02

Contact for this trial

Dimitrios Hatzichristou, Professor

+306944541516 d.hatzichristou@gmail.com