Erectile Dysfunction Due to Arterial InsufficiencyPhase 2NCT07124871
PRP Exosomes Therapy for Erectile Dysfunction
A Phase 2 study testing PRP-derived exosomes injection in people with Erectile Dysfunction Due to Arterial Insufficiency, run by Institute for the Study of Urological Diseases, Greece at 1 site in Greece.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 70 years, men only
- Conditions the study is for
- Erectile Dysfunction Due to Arterial Insufficiency
- What is being tested?
- PRP-derived exosomes injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGreece
- Study dates
- 20 Jun 2025to May 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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).
Who cannot join
- 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.
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
St Lukes Hospital
Thessaloniki, 54636
IOANNIS MYKONIATIS, 6936975862, g_mikoniatis@hotmail.com
About this study
Official title: Platelet Rich Plasma - Derived Exosomes Therapy for Erectile Dysfunction: A Feasibility Clinical 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.
- Being tested
- PRP-derived exosomes injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP-derived exosomes injectionBiological
All 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
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Experimental | All patients will be regular PDE5I users/responders. After one one-month washout period, ED patients will be screened by the IIEF-EF domain, and 30 eligible patients will be enrolled. subjects will receive three sessions of PRP-derived exosomes injection with 21± 3 days treatment interval. Receives: Biological: PRP-derived exosomes injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From baseline to 12 weeks after final treatment
Secondary outcomes (3)
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
Measured: From baseline to 4 weeks after final treatment
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
Measured: From baseline to 12 weeks after final treatment.
Adverse events in all patients
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start20 Jun 2025
- Primary completionFeb 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erectile Dysfunction Due to Arterial InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute for the Study of Urological Diseases, Greece
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124871
- Sponsor's protocol ID
- PRP-DET:7/3/25
- Status last verified
- Aug 2025
- First submitted
- 27 Apr 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Colombo M, Raposo G, Thery C. Biogenesis, secretion, and intercellular interactions of exosomes and other extracellular vesicles. Annu Rev Cell Dev Biol. 2014;30:255-89. doi: 10.1146/annurev-cellbio-101512-122326. Epub 2014 Aug 21.
PubMed 25288114
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Rich Plasma - Derived Exosomes Therapy for Erectile Dysfunction: A Feasibility Clinical Trial
- ClinicalTrials.gov ID
- NCT07124871
- Acronym / sponsor ID
- PRP-DET:7/3/25
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Institute for the Study of Urological Diseases, GreeceUniversity, hospital or other
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Experimental | Biological: PRP-derived exosomes injectionAll patients will be regular PDE5I users/responders. After one one-month washout period, ED patients will be screened by the IIEF-EF domain, and 30 eligible patients will be enrolled. subjects will receive three sessions of PRP-derived exosomes injection with 21± 3 days treatment interval. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRP-derived exosomes injectionAll 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 | Biological | Study Arm |
Primary outcome
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
Time frame: 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
3 secondary outcomes
The % of patients who attain Minimal Clinically Important Difference(MCID) in the International Index for Erectile Function- Erectile Function (IIEF-EF) domain .
Time frame: From baseline to 4 weeks after final treatment
The change of the International Index for Erectile Function- Erectile Function (IIEF-EF) domain from baseline to 12 weeks after final treatment.
Time frame: From baseline to 12 weeks after final treatment.
Adverse events in all patients
Time frame: Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Background: PubMed 25288114Colombo M, Raposo G, Thery C. Biogenesis, secretion, and intercellular interactions of exosomes and other extracellular vesicles. Annu Rev Cell Dev Biol. 2014;30:255-89. doi: 10.1146/annurev-cellbio-101512-122326. Epub 2014 Aug 21.
- Individual participant dataSharing planned: No
Related trials for Erectile Dysfunction Due to Arterial Insufficiency
Recruiting
Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain
Erectile Dysfunction Due to Arterial Insufficiency, Erectile Dysfunction
RecruitingObservational study
EVERiST: Impact of Image Detected Accessory Pudendal Artery on Erection Recovery After Nerve Sparing Prostatectomy
Radical Prostatectomy, Erectile Dysfunction Following Radical Prostatectomy
Not yet recruitingPhase 2
Clinical Trial Investigating the Effect of Exosomes as a Complementary Treatment in Severe to Moderate Erectile Dysfunction
Erectile Dysfunction, Erectile Dysfunction Associated With Type 2 Diabetes Mellitus
Active, not recruiting
Low Intensity Shockwave Therapy for Erectile Dysfunction
Erectile Dysfunction, Erectile Dysfunction Following Radical Prostatectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PRP-derived exosomes injection in people with Erectile Dysfunction Due to Arterial Insufficiency, run by Institute for the Study of Urological Diseases, Greece at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dimitrios Hatzichristou, Professor (+306944541516 ext. +30, d.hatzichristou@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: From baseline to 12 weeks after final treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07124871, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.