Cord blood platelet-rich plasma plus penile traction versus traction alone for Peyronie's disease
Platelet-Rich Plasma Injections From Cord Blood + Penile Traction vs. Penile Traction Alone in Patients With Peyronie's Disease.
This tests whether adding cord blood platelet-rich plasma injections to penile traction helps men with Peyronie's disease and significant penile curvature.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Male |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT07010900 on ClinicalTrials.gov |
What this trial studies
This open-label, single-center randomized study in Milan compares penile traction alone to traction combined with three cord blood–derived platelet-rich plasma (CB-PRP) injections given every 15 days. Men with Peyronie's disease, curvature greater than 30 degrees, and preserved erectile function will be randomized to one of the two arms. The primary outcome is patient satisfaction measured with the PDQ at 1 and 3 months after treatment, and secondary outcomes include goniometer-measured curvature, stretched penile length, SF-12 quality of life, and HADS anxiety/depression scores. Safety screening requires normal blood counts, negative HIV/HCV/HBsAg, and exclusion of prior penile surgery or previous injectable or traction therapies.
Who should consider this trial
Good fit: Men aged 18–75 with Peyronie's disease, penile curvature greater than 30 degrees, preserved erectile function (IIEF >20), normal blood counts, and willingness to use penile traction and attend follow-up visits are the ideal candidates.
Not a fit: Patients with coagulopathies or platelet disorders, active major infections, prior penile surgery or prior infiltrative/traction treatments, or poor erectile function are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, adding CB-PRP to traction could improve patient satisfaction, reduce curvature, and enhance quality of life with a minimally invasive approach.
How similar studies have performed: Autologous PRP for Peyronie's disease has produced limited and mixed results in small studies, and the use of cord blood–derived PRP is novel with little published clinical evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with Peyronie's Disease (IPP) Penile curvature greater than 30 degrees (autophotography in erection with goniometer measurement) Patients candidates for penile traction Age: 18-75 years Good health conditions Preserved erection (IIEF \>20) Complete blood count with differential and coagulation within the normal range (platelets between 150,000 and 450,000 μL) HIV, HCV, and HbsAg negative The fertile partner of the patient randomized to the experimental group must use an acceptable highly effective contraceptive method (oral contraceptives, intrauterine device, abstinence, vasectomized partner) for the entire duration of the study Informed consent to the study Exclusion Criteria: Coagulopathies, platelet disorders Major active infections Previous penile surgery (excluding circumcision and condyloma removal) Previous infiltrative therapy or penile traction treatment
Where this trial is running
Milan
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Franco Gadda, MD
- Email: franco.gadda@policlinico.mi.it
- Phone: +390255033478
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.