NCT04502875

Clinical Trial to Evaluate the Efficacy of Intracavernosal Infusion of PRP vs PPP for the Erectile Dysfunction.

A Randomized, Double-blind Controlled Trial to Evaluate the Efficacy of Intracavernosal Infusion of Platelet Rich Plasma Against Platelet Poor Plasma in the Treatment of Vasculogenic Erectile Dysfunction.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Puerta de Hierro University Hospital · Academic / Other
• Sex: Male
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	PRP	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.
DRUG	PPP	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.

Timeline

• Start date: 2020-02-10
• Primary completion: 2022-02-28
• Completion: 2022-08-31
• First posted: 2020-08-06
• Last updated: 2020-08-06

Locations

1 site across 1 country: Spain