PRP for Peyronie's Disease

Overseen By Ranjith Ramasamy, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: University of Miami

Must not be taking: Anticoagulants

Disqualifiers: Previous penile surgery, Severe erectile dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Platelet-Rich Plasma (PRP) injections can aid men with Peyronie's Disease (PyD), a condition where scar tissue causes curved and painful erections. The study involves two groups: one receives the PRP treatment first, followed by a placebo (inactive substance), while the other starts with the placebo and later receives the PRP treatment. Men diagnosed with Peyronie's Disease and significant penile curvature may be suitable candidates. Participants must adhere to all study-related tests and procedures. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be actively on anticoagulation during the injections, except for aspirin 81 mg, which is allowed.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on anticoagulation (blood thinners) during the time of the injections, except for low-dose aspirin (81 mg).

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that platelet-rich plasma (PRP) injections are generally safe for treating conditions like Peyronie's Disease. In past studies, patients experienced only minor and temporary side effects, such as mild pain or swelling at the injection site, which resolved on their own. Other research supports the safety of PRP, indicating it is well-tolerated by most people. While more studies are needed to fully confirm these findings, current evidence suggests that PRP is a safe option for those considering joining a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Peyronie's Disease?

Researchers are excited about using autologous Platelet Rich Plasma (PRP) for treating Peyronie's Disease because it represents a more natural and potentially less invasive option compared to current treatments like surgery or medication. Unlike these traditional methods, PRP is derived from the patient's own blood, which is thought to promote healing by delivering a concentrated dose of growth factors directly to the affected area. This approach not only minimizes the risk of adverse reactions but also leverages the body's own healing mechanisms. Additionally, PRP might offer a quicker recovery time and fewer side effects, making it an attractive alternative for patients seeking relief from this condition.

What evidence suggests that this treatment might be an effective treatment for Peyronie's Disease?

Research shows that using a person's own blood in Platelet-Rich Plasma (PRP) injections might help men with Peyronie's Disease. Studies have found that PRP can improve the shape and thickness of the penis, which are often affected by the disease. This trial will test two different sequences of treatment: one group will receive the Autologous PRP intervention first, followed by a placebo, while the other group will receive the placebo first, followed by the Autologous PRP intervention. The treatment involves taking a sample of the patient's blood to create a concentrated plasma, which may aid healing and reduce scarring. Patients who have tried this treatment reported improvements in the curve of their penis and fewer symptoms. These findings suggest that PRP could be a promising option for those dealing with Peyronie's Disease. ^{2 6 7 8 9}

Who Is on the Research Team?

Manuel Molina, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Be able to provide written informed consent

Agree to comply with all study related tests/procedures

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

Exclusion Criteria

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

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either autologous PRP or placebo, followed by crossover to the other intervention after 3 months

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Autologous Platelet Rich Plasma

Trial Overview 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.

How Is the Trial Designed?

Group I: Experimental: Placebo followed by Autologous PRP Group Experimental Treatment 2 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 Group Experimental Treatment 2 Interventions

Participants in this group will receive the autologous intervention first, followed by the placebo intervention 3 months later.

Autologous Platelet Rich Plasma is already approved in United States, European Union for the following indications:

Approved in United States as Platelet-Rich Plasma for:

• None FDA-approved; used off-label for various conditions including orthopedic and dermatological applications

Approved in European Union as Platelet-Rich Plasma for:

• None centrally approved; individual countries may have varying regulations and uses

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Published Research Related to This Trial

Intralesional injection of platelet-rich plasma for Peyronie's disease has shown early signs of safety based on observations from an ongoing clinical trial.

Efficacy data for this treatment are still pending and will be available upon completion of the trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase 2 Randomized, Placebo-controlled Crossover Trial to Evaluate Safety and Efficacy of Platelet-rich Plasma Injections for Peyronie's Disease: Clinical Trial Update. Chu, KY., Molina, ML., Ledesma, B., et al.[2023]

In a study of 17 patients receiving platelet rich fibrin matrix (PRFM) injections for urologic conditions, only minor adverse events like mild pain and bruising were reported, indicating a good safety profile.

No decline in erectile function was observed in patients evaluated with the International Index of Erectile Function (IIEF-5) scores, suggesting that PRFM may be a feasible treatment option for erectile dysfunction and other urologic issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and feasibility of platelet rich fibrin matrix injections for treatment of common urologic conditions. Matz, EL., Pearlman, AM., Terlecki, RP.[2022]

In a study involving 17 patients with Peyronie's disease, three intra-platelet-rich plasma (PRP) injections were administered, showing no side effects and significant improvements in the Peyronie's Disease Questionnaire (PDQ) scores after treatment.

The angle of curvature of the penis decreased significantly by 11.8°, and erectile function improved, with the IIEF-EF score increasing by an average of 5 to 7 points at various follow-up intervals, indicating potential efficacy of PRP injections in treating Peyronie's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerance and efficacy of platelet-rich plasma injections in Peyronie's disease: Pilot study. Schirmann, A., Boutin, E., Faix, A., et al.[2022]

In a study involving 20 male rats, intratunical injections of platelet-rich plasma (PRP) did not show significant differences in fibrosis or collagen ratios compared to the Peyronie's disease (PD) group, suggesting that PRP may mimic PD effects rather than provide therapeutic benefits.

This research indicates that PRP could serve as a cost-effective and accessible model for studying Peyronie's disease treatment, although its efficacy in actually treating the condition remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Platelet-Rich Plasma on Peyronie's Disease in Rat Model. Culha, MG., Erkan, E., Cay, T., et al.[2019]

The combination of low intensity external shock wave therapy (Li-ESWT) and platelet-rich plasma (PRP) therapy significantly improved outcomes in patients with acute Peyronie's disease, including reductions in plaque size and penile curvature, as well as enhancements in erectile function and pain scores.

This treatment was found to be safe, with no reported side effects such as ecchymosis or hematoma at the injection sites, indicating a favorable safety profile for early intervention in Peyronie's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new alternative approach to management of acute phase Peyronie's disease: low intensity extracorporeal shockwave therapy and platelet-rich plasma. Karakose, A., Yitgin, Y.[2023]

In a study involving 65 patients with Peyronie's disease, repeated intralesional injections of platelet-rich plasma (PRP) significantly improved penile curvature by an average of 16.88° to 17.27°, demonstrating both safety and efficacy over a 12-month period.

Additionally, the treatment led to a notable reduction in pain during intercourse, decreasing from 70.7% to 34.25%, with over half of the patients reporting easier sexual intercourse, highlighting the positive impact on quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet-rich plasma in patients affected with Peyronie's disease. Achraf, C., Abdelghani, PA., Jihad, PEA.[2023]

Platelet-rich plasma (PRP) therapy shows promise for treating erectile dysfunction (ED) and Peyronie's disease (PD) due to its regenerative properties, with a review of 10 trials (4 preclinical and 6 clinical) indicating no adverse reactions associated with its use.

However, the studies reviewed had limitations such as small sample sizes and short follow-up periods, suggesting that while PRP has potential, more robust research is needed to confirm its safety and effectiveness in treating male sexual dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet-Rich Plasma Therapy for Male Sexual Dysfunction: Myth or Reality? Epifanova, MV., Gvasalia, BR., Durashov, MA., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10208162/

Platelet-rich plasma in patients affected with Peyronie's ... In this article, we describe the evidence regarding the effectiveness and the safety profile of autologous PRP injections in the treatment of ...

2. oatext.com oatext.com/evaluation-of-the-benefit-of-using-a-combination-of-autologous-platelet-rich-plasma-and-hyaluronic-acid-for-the-treatment-of-Peyronies-disease.php

Evaluation of the benefit of using a combination ... Repeated intralesional injections of PRP-HA improve significantly penile deformation and thickening of the TA. This fully natural treatment may stand as a ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07117955

NCT07117955 | Platelet-Rich Plasma for Peyronie's Disease A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may ...

4. precisionsexualhealth.com precisionsexualhealth.com/wp-content/uploads/2022/09/62-Evaluation-of-the-benefit-of-using-a-combination-of-autologous-injection-therapy-and-dermal-fillers-for-the-treatment-of-Peyronies-disease.pdf

Evaluation of the benefit of using a combination of autologous ... Patient summary: We evaluated here an innovative treatment of Peyronie's disease using intralesional injections of Platelet-Rich Plasma mixed ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/uro2.104

Current insights and future directions in Peyronie's disease ... In this review, we summarize the current knowledge regarding PD, including etiology and epidemiology, diagnosis, management, cutting-edge research, and future ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11136842/

Platelet-rich plasma therapy in erectile dysfunction and ... Trials confirm the procedure's safety, noting only minor and temporary adverse events and most seem to indicate small to moderate positive ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1166708722001324

Tolerance and efficacy of platelet-rich plasma injections in ... Conclusion. Our initial experience suggests that PRP injections for Peyronie's disease are safe. Although the limited data is suggestive of efficacy, a placebo ...

8. wjmh.org wjmh.org/pdf/10.5534/wjmh.240310

Clinical Effects and Safety Outcomes of Platelet-Rich ... Data on study characteristics, PRP protocols, and outcomes using validated erectile function measures and penile Doppler parameters were ...

9. clinicaltrial.be clinicaltrial.be/en/details/53461?active_not_recruiting=1&completed=0&enrolling_by_invitation=1&only_active=0&only_eligible=0&only_recruiting=0&per_page=20

PRP for Treatment of Peyronie's Disease The purpose of this study is to learn about the effects of Platelet-Rich Plasma (PRP) injection in men with Peyronie's Disease (PyD). Trial ...