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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
PRP-derived exosomes injection
Biological/VaccineAll subjects will receive three sessions of PRP-derived exosomes injection with 21± 3 days treatment interval.The patient will be positioned supine. A ¼-inch Penrose drain will be used as a tourniquet by placing it at the base of the penis and maintaining it in place under tension by a sterile clamp. We will obtain 10 mL of PRP per patient, but one of them will be used for platelet cell count analysis. A total 9 mL of the PRP-derived exosomes will be infused steadily over a 2 minutes period - 4.5 mL each into the right and left corpus cavernosum. The infusion will be performed at this slow speed - each side over 2 minutes of infusion - to minimize injury to the exosomes and cells. Following administration, compression of the penis will be achieved with a clenched fist for 20 minutes. At 20 minutes, the tourniquet will be removed, and a compressive dressing will be placed around the penile shaft. The patient will be instructed to remove the compression bandage in 4 hours
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Study ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
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. MCID values for the IIEF-EF (Erectile Function) domain are 2-point increase for mild ED, a 5-point increase for moderate ED and a 7-point increase for severe ED In IIEF-EF score higher values mean better outcome
Time frame
From baseline to 12 weeks after final treatmentSecondary outcomes
1
The % of patients who attain Minimal Clinically Important Difference(MCID) in the International Index for Erectile Function- Erectile Function (IIEF-EF) domain .
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. MCID values for the IIEF-EF (Erectile Function) domain are 2-point increase for mild ED, a 5-point increase for moderate ED and a 7-point increase for severe ED In IIEF-EF score higher values mean better outcome
Time frame
From baseline to 4 weeks after final treatment2
The change of the International Index for Erectile Function- Erectile Function (IIEF-EF) domain from baseline to 12 weeks after final treatment.
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. MCID values for the IIEF-EF (Erectile Function) domain are 2-point increase for mild ED, a 5-point increase for moderate ED and a 7-point increase for severe ED In IIEF-EF score higher values mean better outcome
Time frame
From baseline to 12 weeks after final treatment.3
Adverse events in all patients
Time frame
PeriproceduralSponsors and contacts
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Source ClinicalTrials.gov