PRP for the Treatment of Erectile Dysfunction (ED)

Study Overview
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Brief Summary
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Researchers are trying to determine the safety and efficacy of Platelet Rich Plasma (PRP) in the treatment of Erectile Dysfunction (ED).

Official Title
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A Pilot Study Evaluating the Use of Autologous Platelet-rich Plasma (PRP) for the Treatment of Erectile Dysfunction

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Biological: Autologous Platelet Rich Plasma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must have given his informed and signed written consent The patient has ED for longer than 1 year but less than 5 years. The subject has a stable partner for at least 3 months. The patient is PDE5i responsive, meaning he is able to achieve and maintain an erection under the effect of the maximal dosage of PDE5i IIEF-EF, EHS, SEP 2+3, and GAQ Domain score of 17-20 Mild to moderate vascular erectile dysfunction: PSV > 25 cm/sec Exclusion Criteria: The patient is participating in another study that may interfere with the results or conclusions of this study History of radical prostatectomy or pelvic cancer surgery Prior history of pelvic malignancies Prior pelvic radiation therapy Neurological disease which effects erectile function (Spinal cord injury, iatrogenic injury to the pelvic or cavernous nerves) Psychiatric disease which effects erectile function The patient is taking blood thinners History of Diabetes Mellitus History of Coronary Artery Disease Evidence Based Criteria: Doppler Clinical Exam ( PSV < 25 cm/sec defined criteria for severe erectile dysfunction not likely to respond to approved medical therapies) Biochemical evidence of Hypogonadism (total Testosterone < 300 ng/dL)

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Interventional Model Description: Subjects treated in this study will be divided into 3 cohorts of 5. After the first cohort of 5 subjects have been treated and evaluated for safety, the second cohort of 5 subjects will proceed with treatment followed by review of events for safety. If determined safe to proceed the third cohort of 5 subjects will proceed with treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet Rich Plasma Treatment<br>Male subjects diagnosed with Erectile Dysfunction (ED) will receive platelet rich plasma injections. | Biological: Autologous Platelet Rich Plasma<br>* One 4-5mL platelet rich plasma injection administered to each side of the intracavernosal space on the right and left side of the corpus cavernosum at the base of the penis, every two weeks for 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-related adverse events | Number of participants to experience treatment-related adverse events defined as reaction in the skin (e.g., swelling, erythema, and warmth), injection site discomfort, penile pain, change in penile appearance, novel sexual concerns and any systemic reactions seen by the investigators, or concerns expressed by patients. | 35 weeks |