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

65 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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).

What data supports the idea that PRP for Peyronie's Disease is an effective treatment?

The available research shows that PRP injections are being explored as a treatment for Peyronie's Disease, but the results are not yet clear. One study mentions that PRP injections are being used more often since another treatment was discontinued, but it doesn't provide specific results. Another study in rats aimed to see how PRP affects Peyronie's Disease, but it doesn't mention the outcomes. A clinical trial update suggests that PRP injections are safe, but it doesn't provide data on how well they work. Lastly, a study looked at combining PRP with another therapy, but it doesn't specify the effectiveness of PRP alone. Overall, while PRP is being tested, there isn't enough clear data yet to say how effective it is for treating Peyronie's Disease. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Autologous Platelet Rich Plasma for Peyronie's Disease?

Research on platelet-rich plasma (PRP) injections for Peyronie's disease is still ongoing, with some studies suggesting it is safe, but clear evidence of its effectiveness is not yet available. However, PRP has been used in other conditions to promote healing and reduce inflammation, which might suggest potential benefits for Peyronie's disease. ^{1 2 3 4 5}

What safety data exists for PRP treatment in Peyronie's Disease?

Several studies suggest that PRP injections for Peyronie's Disease are generally safe. A Phase 2 trial indicates early observations of safety, though efficacy data is pending. Another study reviewed the safety and feasibility of PRP in urologic conditions, including Peyronie's Disease, highlighting the need for safety analysis before clinical trials. Overall, PRP is considered safe based on initial findings, but more comprehensive data is needed. ^{1 2 3 4 6}

Is platelet-rich plasma (PRP) safe for use in humans?

Early observations from clinical trials suggest that PRP injections for Peyronie's disease appear to be safe. PRP has been used for decades in various medical settings to aid healing, with little data indicating significant safety concerns. ^{1 2 3 4 6}

Is the treatment Autologous Platelet Rich Plasma a promising treatment for Peyronie's Disease?

Autologous Platelet Rich Plasma (PRP) is a promising treatment for Peyronie's Disease because it uses the body's own healing factors to help repair tissues. PRP has been used in various medical fields to promote healing and improve conditions like erectile dysfunction and Peyronie's Disease by encouraging tissue regeneration and improving blood flow. ^{1 2 3 6 7}

How is the PRP treatment for Peyronie's Disease different from other treatments?

PRP (Platelet-Rich Plasma) treatment for Peyronie's Disease is unique because it involves injecting a concentration of the patient's own platelets directly into the affected area, which may promote tissue regeneration and healing through growth factors. This approach is different from traditional treatments as it uses the body's natural healing components rather than external medications or surgery. ^{1 2 3 6 7}

Research Team

Manuel Molina, MD

Principal Investigator

University of Miami

Eligibility Criteria

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

I am between 18 and 75 years old.

I am between 18 and 75 years old.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

References

1. France pubmed.ncbi.nlm.nih.gov

Tolerance and efficacy of platelet-rich plasma injections in Peyronie's disease: Pilot study. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

The Effect of Platelet-Rich Plasma on Peyronie's Disease in Rat Model. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Platelet-rich plasma in patients affected with Peyronie's disease. [2023]

4. Netherlands 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. [2023]

5. Italy 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. [2023]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Safety and feasibility of platelet rich fibrin matrix injections for treatment of common urologic conditions. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Platelet-Rich Plasma Therapy for Male Sexual Dysfunction: Myth or Reality? [2021]