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Platelet-Rich Plasma
PRP for Peyronie's Disease
Phase 2
Recruiting
Led By Manuel Molina, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be 18 to 75 years of age (inclusive)
Be 18 to 75 years of age (inclusive).
Must not have
Patients scheduled to undergo an elective medical procedure during the investigation timeframe that will interfere with autologous PRP injection therapy.
PD characterized by a ventral plaque
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 months
Awards & highlights
Summary
This trial studies the effects of PRP injections in men with Peyronie's Disease. PRP is made from a person's own blood and contains growth factors that help heal tissues. The goal is to see if PRP can reduce scar tissue and improve symptoms. PRP is a relatively new approach in regenerative medicine, derived from a patient's own blood and rich in growth factors that promote tissue healing.
Who is the study for?
Men aged 18-75 with Peyronie's Disease, having a penile curvature between 30° and 120°. Candidates must be able to consent, follow study procedures, and have no serious illnesses that affect participation. Excluded are those with hour-glass deformity, prior penile surgeries (other than circumcision), on strong anticoagulants, or unfit for sexual activity.
What is being tested?
The trial is investigating the effects of injecting Platelet-Rich Plasma (PRP) into men with Peyronie's Disease compared to saline solution injections. The goal is to see if PRP can improve the condition.
What are the potential side effects?
Possible side effects may include pain at injection site, minor bleeding or bruising due to needle insertion, infection risk at the injection area, and allergic reactions to components in PRP.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
Select...
I am between 18 and 75 years old.
Select...
I have Parkinson's disease with active or stable symptoms.
Select...
I am male.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a planned medical procedure that might affect my PRP therapy.
Select...
I have Peyronie's disease with a plaque on the front side of my penis.
Select...
I have had injections directly into my Peyronie’s disease lesions before.
Select...
I have an hour-glass shaped deformity.
Select...
I am willing to participate in the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of subjects achieving any decrease in PDQ sub-domain scores (Psychological and Physical Symptoms, Symptom Bother).
Curvature of spine
Secondary study objectives
Incidence of adverse events in all patients
Side effects data
From 2023 Phase 2 trial • 61 Patients • NCT043967954%
Reproductive system and breast disorders - Other, specify
100%
80%
60%
40%
20%
0%
Study treatment Arm
PRP Group
Placebo Group
Trial Design
2Treatment groups
Experimental Treatment
Group I: Experimental: Placebo followed by Autologous PRP GroupExperimental Treatment2 Interventions
Participants in this group will receive the placebo intervention first, followed by the Autologous PRP intervention 3 months later.
Group II: Experimental: Autologous PRP followed by Placebo GroupExperimental Treatment2 Interventions
Participants in this group will receive the autologous intervention first, followed by the placebo intervention 3 months later.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Autologous Platelet Rich Plasma
2022
Completed Phase 2
~210
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Platelet-Rich Plasma (PRP) injections are a promising treatment for Peyronie's Disease, leveraging the body's natural healing mechanisms. PRP is rich in growth factors and cytokines, which promote tissue regeneration and repair.
This is crucial for Peyronie's Disease patients, as the condition is characterized by fibrous scar tissue formation in the penis, causing curvature and discomfort. By enhancing the healing process, PRP injections aim to reduce scar tissue, alleviate pain, and improve penile function, offering a potential therapeutic option for those affected by this condition.
Find a Location
Who is running the clinical trial?
University of MiamiLead Sponsor
945 Previous Clinical Trials
427,526 Total Patients Enrolled
2 Trials studying Peyronie's Disease
102 Patients Enrolled for Peyronie's Disease
Manuel Molina, MDPrincipal InvestigatorUniversity of Miami
Ranjith Ramasamy, MDPrincipal Investigator - University of Miami
Univ of Miami Hosp & Clinics-Sylvester Comp Cancer Center, University of Miami Hospital
12 Previous Clinical Trials
704 Total Patients Enrolled
1 Trials studying Peyronie's Disease
80 Patients Enrolled for Peyronie's Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a planned medical procedure that might affect my PRP therapy.I am between 18 and 75 years old.You have had a previous occurrence of priapism (a painful, prolonged erection) or a penile fracture.I have not had penile surgery, except for circumcision or condyloma removal.I have Peyronie's disease with a plaque on the front side of my penis.I am currently taking blood thinners, but aspirin 81 mg is okay.The doctor in charge thinks you are not healthy enough to have sex.I have had injections directly into my Peyronie’s disease lesions before.I am between 18 and 75 years old.You have severe difficulty in getting or maintaining an erection, as measured by a test called International Index of Erectile Function (IIEF) score, which is less than or equal to 16.I have an hour-glass shaped deformity.I have Parkinson's disease with active or stable symptoms.Your penis has a curve that is too severe or not severe enough.I am willing to participate in the trial.You agree to comply with all study related tests/procedures.I am male.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: Autologous PRP followed by Placebo Group
- Group 2: Experimental: Placebo followed by Autologous PRP Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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