Platelet-rich Plasma (PRP) Injection for Treatment of Erectile Function

Inclusion Criteria:

1. Consent to participate.

2. Age 40-70 years.

3. Sexually active in a stable, heterosexual relationship of more than three monthsduration.

4. Presence of Erectile Dysfunction for at least 6 months.

5. IIEF-ED: 11-25 at visit 1

6. PDE5i users and report some/good response to PDE5i at the last month before screening.

7. Agree to suspend all ED therapy for the duration of the study.

8. Agree to attempt sexual intercourse at least 4 times every 4 weeks, for the durationof the study without being under the influence of alcohol or recreational drugs. Agreeto document the outcome using the Sexual Encounter Profile (SEP) diary, as needed.

Exclusion Criteria:

1. Previous major pelvic surgery or pelvic trauma that could impact erectile function,such as radical prostatectomy, radical cystectomy, rectal surgery. Patients withprevious TURP surgery without sequelae of iatrogenic ED, may be included.

2. Previous penile surgery of any kind except circumcision and condyloma removal, such aspenile lengthening, penile cancer surgery, penile plication, grafting.

3. Previous history of priapism or penile fracture

4. Previous radiation therapy to pelvis.

5. Abnormal morning serum testosterone level defined as a value lower than 300 ng/dL +/- 5 %(indicative of untreated hypogonadism), or greater than 1197 ng/dL +/- 5%.

6. Current or previous hormone usage, other than prescribed testosterone, clomiphene orthyroid medication. Subjects with prior or current use of hormonal treatment forprostate cancer are also excluded.

7. Psychogenic ED.

8. Peyronie's Disease or penile curvature that negatively influences sexual activity.

9. Anatomical or neurological abnormalities in the treatment area.

10. Any untreated medical condition (medical history)

11. Patients with generalized polyneuropathy, or neurological conditions irrespective ofcause, such as severe diabetes, multiple sclerosis or Parkinson's Disease.

12. Refusal to suspend ED therapy for duration of study. Subjects who are using Tadalafilas a treatment for BPH (Benign Prostatic Hyperplasia) will also be excluded.

13. Men deemed not healthy enough to participate in sexual activity.

14. Any condition or behavior that indicates to the Principal Investigator that thesubject is unlikely to be compliant with study procedures and visits.

15. Any health history or laboratory result that indicates to the Principal Investigatorthat the subject has a significant medical condition and should not participate in thestudy.

16. History of consistent treatment failure with PDE5 inhibitors for therapy of ED.

17. Any history of significant psychiatric disease, such as bipolar disorder or psychosis,greater than one lifetime episode of major depression, current depression of moderateor greater severity. Patients who are currently using SSRI or psychotropicmedications.

18. Partners who are < 18 years of age, who are nursing, who are known to be pregnant atscreening, who wish to become pregnant during the study period, who have anygynecologic problems, sexual dysfunction, or major medical conditions that would limitparticipation in sexual intercourse.

19. Patients with any hematological disorder.