What side effects are associated with this type of intervention?

Platelet-Rich Plasma (PRP) injections for Peyronie's Disease are generally well-tolerated, but some men may experience penile pain. Unlike other treatments such as alprostadil injections, PRP does not typically cause priapism or penile fibrosis. Other common treatments for Peyronie's Disease, such as surgical options, may carry risks of infection, bleeding, and erectile dysfunction. Overall, PRP is considered a safer option with fewer severe side effects, but further studies are needed to confirm its efficacy and safety.

What prior FDA approvals exist?

The FDA has approved several treatments for Peyronie's Disease, including collagenase clostridium histolyticum (Xiaflex), which is an enzyme that breaks down collagen buildup causing penile curvature. While PRP injections are being studied for their potential to promote healing and tissue regeneration through growth factors and cytokines, they have not yet received FDA approval for this indication. Current approved treatments focus on enzymatic breakdown of fibrous tissue rather than regenerative approaches.

What other types of research exist?

Promising, novel alternatives to PRP injections for Peyronie's Disease patients in 2024 include stem cell therapy and low-intensity shock therapy (LIST). Stem cell therapy involves the use of adipose-derived stem cells or other sources to promote tissue regeneration. LIST involves delivering low-intensity shocks to the penile tissue to stimulate neovascularization and improve blood flow.

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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

No Placebo-Only Group

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 below

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I am between 18 and 75 years old.

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I am between 18 and 75 years old.

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I have Parkinson's disease with active or stable symptoms.

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I am male.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a planned medical procedure that might affect my PRP therapy.

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I have Peyronie's disease with a plaque on the front side of my penis.

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I have had injections directly into my Peyronie’s disease lesions before.

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I have an hour-glass shaped deformity.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 months for reporting.

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 • NCT04396795

Reproductive system and breast disorders - Other, specify

100%

80%

60%

40%

20%

Study treatment Arm

PRP Group

Placebo Group

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 9Eligibility criteria met

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.