Actively Recruiting
PRP Exosomes Therapy for Erectile Dysfunction
Led by Institute for the Study of Urological Diseases, Greece · Updated on 2025-08-15
30
Participants Needed
1
Research Sites
45 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
PRP Exosomes Therapy for Erectile Dysfunction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Consent to participate.
- Age 40-70 years.
- Male sex.
- Sexually active in a stable, heterosexual relationship for more than 3 months.
- Presence of erectile dysfunction for at least 6 months.
- IIEF Erectile Function score between 17 and 25 at visit 2.
- PDE5 inhibitor use for at least 6 months with some or good response in the last month.
- Agree to suspend all ED therapy for the study duration.
- Agree to attempt sexual intercourse at least 4 times every 3 weeks during the study without alcohol or recreational drugs.
- Agree to complete IIEF questionnaires and Sexual Encounter Profile diary during visits and follow-ups.
You will not qualify if you...
- Previous major pelvic surgery or trauma impacting erectile function (e.g., radical prostatectomy, cystectomy, rectal surgery).
- Previous penile surgeries except circumcision and condyloma removal.
- History of priapism or penile fracture.
- Previous pelvic radiation therapy.
- Abnormal morning serum testosterone (<300 or >1197 ng/dL).
- Current or past hormone use except prescribed testosterone, clomiphene, or thyroid medication.
- Hormonal treatment for prostate cancer.
- Psychogenic erectile dysfunction.
- Peyronie's Disease or significant penile curvature.
- Anatomical or neurological abnormalities in the treatment area.
- Untreated medical conditions.
- Generalized polyneuropathy or neurological diseases such as severe diabetes, multiple sclerosis, or Parkinson's Disease.
- Refusal to suspend ED therapy during the study; use of Tadalafil for BPH.
- Poor health status for sexual activity.
- Any condition or behavior suggesting noncompliance.
- Significant medical conditions based on history or labs.
- History of consistent PDE5 inhibitor treatment failure.
- Significant psychiatric diseases or current moderate/severe depression.
- Current use of SSRI or psychotropic medications.
- Partners under 18, nursing, pregnant, or with gynecologic/sexual dysfunction limiting intercourse.
- Hematological disorders.
AI-Screening
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Trial Site Locations
Total: 1 location
1
St Lukes Hospital
Thessaloniki, Greece, 54636
Actively Recruiting
Research Team
D
Dimitrios Hatzichristou, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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