| Eligibility |
Inclusion Criteria:
1. Men aged 40 - 70
2. Willing and able to provide written informed consent
3. Chronic, organic erectile dysfunction (ED), duration at least 0.5 years, with baseline
International Index of Erectile Function - Erectile Function (IIEF-EF) score of < 26
4. Willing to complete questionnaires
5. Involved in a monogamous, heterosexual relationship for at least 3 months with both
partners motivated to have or attempt sexual intercourse at least 4 times per month
beginning two weeks after study treatment (subject reported)
6. Not interested or able to use oral PDE-5 inhibitor (PDE-5i) drug therapy, and willing
to forgo these treatments for the first 6-month period following study treatment (in
addition may include a minimum 4-week washout since last PDE-5i use prior to
completion of the baseline erectile function assessments and study treatment)
7. Willing to limit alcohol intake and eliminate use of recreational drugs for sexual
encounters
8. Willing to undergo a minor surgical procedure and injection
9. Abdominal area amenable to liposuction of at least 60-120 cc of adipose tissue based
on Investigator examination
10. Mentally competent and able to understand all study requirements (based on
investigator assessment)
11. Willing to be available for all baseline, treatment and follow-up examinations
required by protocol
12. Willing to forego participation in any other study throughout the duration of this
study unless receiving prior approval by Sponsor.
Exclusion Criteria:
1. Evidence of prostate cancer which requires additional radiotherapy or other adjuvant
therapy
2. Previous pelvic or abdominal radiation therapy
3. Previous, concomitant or scheduled use of anti-androgen therapy
4. Untreated hypogonadism or low serum total testosterone (< 200 ng/dL)
5. Clinically evident penile anatomical deformities (e.g., Peyronie's disease) or history
of priapism
6. Skin irritation, infection, wound, sore or disruption in the immediate areas of skin
entry for abdominal liposuction or penile injection (including abdominal trauma and
abdominal skin cancer (basal cell carcinoma, squamous cell carcinoma, and melanoma))
7. Use of any non-study treatment for erectile dysfunction within 4 weeks of study
treatment and a lack of willingness to continue through 6 months after study treatment
8. Any previous penile implant or penile vascular surgery
9. Current or previous malignancy other than localized prostate cancer or nonabdominal,
non-melanoma skin cancer (successfully treated or treatable by curative excision or
other local curative therapy- abdominal skin cancer is exclusionary as indicated in
criteria 6)
10. Uncontrolled hypertension or hypotension (systolic blood pressure > 170 or < 90 mm Hg,
and diastolic blood pressure > 100 or < 50 mm Hg)
11. Reported unstable cardiovascular disease (e.g., unstable angina, myocardial infarction
within past 6 months, cardiac failure or life-threatening arrhythmia, congestive heart
failure) or symptomatic postural hypotension within 6 months before screening
12. Hemoglobin A1c > 8% within 8 weeks prior to study treatment
13. Current urinary tract or bladder infection
14. Drug, alcohol, or substance abuse reported within the last three years (subject
reported)
15. Subject's sexual partner is < 18 years of age, nursing, or known to be pregnant at
screening, or wishes to become pregnant during the study period, or has any
gynecologic problems, major medical conditions, or other factors that would limit
participation in sexual intercourse to less than 4 times per month (subject reported)
16. Weight less than 154 lbs/ 70 kg, or BMI = 30
17. Unable to limit or avoid nonsteroidal anti-inflammatory drugs(NSAIDs) for 15 days
prior to treatment (subject reported)
18. Bleeding or clotting disorder, use of anticoagulant therapy, or history of easy or
excessive bruising
19. Lab values for Complete Blood Count(CBC), Prothrombin Time(PT)/Partial Thromboplastin
Time(PTT)/International Normalized Ration(INR), liver function and creatinine falling
outside the normal lab values (see section 5.3 for further detail)
20. Systemic autoimmune disorder
21. Significant active systemic or localized infection
22. Receiving immunosuppressant medications
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