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Randomized, double-blind clinical trial to evaluate efficacy, feasibility and safety with two groups in a 1:1 ratio; where the control group corresponds to patients who will receive Platelet Poor plasma and an experimental group where patients will receive Platelet Rich Plasma, both collected by apheresis.
Patients treated in the urology department of the Hospital Universitario Puerta de Hierro Majadahonda, are eligible and will be offered the participation in this clinical trial.
The target populations are patients who presented erectile dysfunction for at least 6 months with an IIEF-EF between 5 and 16 points. They will be pre-screened for eligibility.
The patient must complete the informed consent form (ICF) process and sign and date the informed consent form prior to participation in this study, including completion of any non-standard-of- care procedures required for this clinical Investigation.
If the patient meets the inclusion criteria and additionally meet with the apheresis procedures, the patient wil be included in the study.
The study include two phases. In the first phase, the patient will be randomized to PPP or PPP. In the second phase, according with the score IIEF-EF (responder or non responder), the patient will receive PRP.
With the responders patients, an open phase with PDE5-Is is initiated. The patient will use phosphodiesterase 5 inhibitors (PDE5-Is) at maximum tolerated doses according with the Summary Product of characteristics.
With the no responders patients, there will be two options:
If the non-responder patient was in treatment with PRP during the firs phase, the patient will continue with the procedures of visits 11a and 12a.
If the non-responder patient was in treatment with PPP, the patient will start the second phase of treatment with PRP and will continue with the procedures of this treatment phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | Intracavernosal infusion of Platelet Rich Plasma |
|
| Control Arm | Active Comparator | Intracavernosal infusion of Platelet Poor Plasma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRP | Drug | Platelet Rich Plasma (PRP) is an autologous blood component derivate from the own patient blood, with a high concentration in platelets. The liquid fraction obtained after the soft centrifugation of Whole Blood (WB) collected with anticoagulant, in a way that most of the red cells and leukocytes are sedimented and removed, but most of the platelets are kept in the supernatant plasma. The platelet concentration in PRP is not well defined. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference of increments between PRP and PPP treatment assessed by IIEF scale | Difference of increments between both treatment groups assesed by International Index Erectile Function (IIEF) scale (referred to the investigator's study as mean PRP V9(PT)IIEF-EF - V3IIEF-EF vs mean PPP V9(PT)IIEF-EF - V3IIEF-EF) after 4 weeks of the end of the treatment. | 28 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events related with the use of PRP/PPP | Incidence of infusion related Adverse Events (AEs) and cumulative of incidence of Serious Adverse Events (SAEs) during the clinical trial. | 28 weeks |
| Synergic efficcacy of PRP and PDE5 inhibitors |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan Ignacio MartÃnez-Salamanca, MD, PhD | Contact | +34 91 191 71 95 | jims@lyxurologia.com | |
| Gustavo Centeno, MD, PhD | Contact | 91 191 6026 | gustavoadolfo.centeno@salud.madrid.org |
| Name | Affiliation | Role |
|---|---|---|
| Juan Martinez-Salamanca, Md, PhD | Urologist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Puerta de Hierro University Hospital | Recruiting | Majadahonda | Madrid | 28222 | Spain |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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Randomized, double-blind clinical trial to evaluate efficacy, feasibility and safety with two groups in a 1:1 ratio; where the control group corresponds to patients who will receive PPP and an experimental group where patients will receive PRP, both collected by apheresis.
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|
| PPP | Drug | PPP is the liquid fraction obtained after the hard centrifugation of WB collected with any anticoagulant. PPP does not contain cells. (Hematocrit lower than 1% and leukocytes below 1 x 109/L) x but contains WB proteins (including clotting factors), ions, microelements and water. PPP can be also being collected using an apheresis technique. |
|
Assessment of the synergic efficacy of PRP treatment on the therapeutic response to oral administration of PDE5 inhibitors by the IIEF. |
| 28 weeks |
| Concentration of cytokines and growth factors in the PRP and PPP | Concentration of cytokines and growth factors concentration in the PRP and PPP of each patient and their relationship with the clinical response to PRP assessed by IIEF. | 28 weeks |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |