PRP-derived exosome injections for erectile dysfunction from poor blood flow

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

This Phase 2 trial will test whether injections of platelet-rich plasma (PRP)–derived exosomes can improve erections in men aged 40–70 with mild to moderate vasculogenic erectile dysfunction.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 40 Years to 70 Years
• Sex: Male
• Sponsor: Institute for the Study of Urological Diseases, Greece (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Thessaloniki)
• Trial ID: NCT07124871 on ClinicalTrials.gov

What this trial studies

This is a single-arm, single-center Phase 2 feasibility trial delivering PRP-derived exosome injections to men with mild-to-moderate vasculogenic erectile dysfunction due to arterial insufficiency. Participants will stop other ED therapies for the study period and attend visits for treatment, safety monitoring, and outcome measurement. The primary outcome is change in the International Index of Erectile Function (IIEF) score; secondary outcomes include adverse events and other safety measures. All laboratory testing will be centralized at the hospital microbiology lab and PRP-exosome preparation and administration will occur at the affiliated regenerative clinic.

Who should consider this trial

Good fit: Ideal candidates are sexually active men aged 40–70 with at least 6 months of mild-to-moderate vasculogenic ED (IIEF-ED 17–25), who have been using and responding to PDE5 inhibitors and are willing to suspend other ED treatments and follow study visit requirements.

Not a fit: Patients with severe ED, non-vasculogenic causes of erectile dysfunction, prior major pelvic surgery, or those unable/unwilling to stop other ED treatments or attend the Thessaloniki site are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this could offer a minimally invasive regenerative option that improves erectile function for men with vasculogenic ED.

How similar studies have performed: This regenerative exosome approach is relatively novel; small early-phase and preclinical studies of PRP or cell-derived exosomes show preliminary promise but large controlled trials are lacking.

Eligibility criteria

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.
* Any untreated medical condition (based on medical history)
* Patients with generalized polyneuropathy or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis, or Parkinson's Disease.
* Refusal to suspend ED therapy for the duration of the study. Subjects who are using Tadalafil as a treatment for benign prostatic hyperplasia (BPH) will also be excluded.
* Men deemed not healthy enough to participate in sexual activity.
* Any condition or behavior that indicates to the Principal Investigator that the subject is unlikely to be compliant with study procedures and visits.
* Any health history or laboratory result that indicates to the Principal Investigator that the subject has a significant medical condition and should not participate in the study.
* History of consistent treatment failure with PDE5 inhibitors for therapy of ED.
* Any history of significant psychiatric diseases, such as bipolar disorder or psychosis, greater than one lifetime episode of major depression, current depression of moderate or greater severity.
* Patients who are currently using SSRI or psychotropic medications.
* Partners who are \< 18 years of age, who are nursing, who wish to become pregnant during the study period, and who have any gynecologic problems, sexual dysfunction, or major medical conditions that would limit participation in sexual intercourse.
* Patients with any hematological disorder

Where this trial is running

Thessaloniki

• St Lukes Hospital — Thessaloniki, Greece (Recruiting)

Study contacts

• Study coordinator: Dimitrios Hatzichristou, Professor

Conditions Erectile Dysfunction Due to Arterial Insufficiency