Erectile Dysfunction
Conditions
Brief summary
Researchers are trying to determine the safety and efficacy of Platelet Rich Plasma (PRP) in the treatment of Erectile Dysfunction (ED).
Interventions
BIOLOGICALAutologous Platelet Rich Plasma
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.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
MALE
Age
45 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-related adverse events | 35 weeks | 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. |
Countries
United States
Outcome results
None listed