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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRP-derived exosomes injection | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From baseline to 12 weeks after final treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dimitrios Hatzichristou, Professor | Contact | +306944541516 | +30 | d.hatzichristou@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Lukes Hospital | Recruiting | Thessaloniki | 54636 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25288114 | Background | 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. |
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|
| 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 | From baseline to 12 weeks after final treatment. |
| Adverse events in all patients | Periprocedural |