PRP Exosomes Therapy for Erectile Dysfunction
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age40-70
SponsorInstitute for the Study of Urological Diseases, Greece
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- PRP-derived exosomes injection
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov