Evaluation of the Tissue Genesis Icellator Cell Isolation System to Treat Erectile Dysfunction

Exclusion Criteria

• •Evidence of prostate cancer which requires additional radiotherapy or other adjuvant therapy, or PSA \> 0 after radical prostatectomy
• •Previous pelvic or abdominal radiation therapy
• •Anti-androgen therapy within the last 12 months or anti-androgen therapy of greater than 6 months in duration
• •Untreated hypogonadism or low serum total testosterone (\< 300 ng/dL)
• •Clinically evident penile anatomical deformities (e.g., Peyronie's disease) or history of priapism
• •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)
• •Any previous penile implant or penile vascular surgery
• •Current or previous malignancy other than localized prostate cancer or non-abdominal, non-melanoma skin cancer (successfully treated or treatable by curative excision or other local curative therapy- abdominal skin cancer is exclusionary)
• •Uncontrolled hypertension or hypotension (systolic blood pressure \> 170 or \< 90 mm Hg, and diastolic blood pressure \> 100 or \< 50 mm Hg)
• •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
• •Hemoglobin A1c \> 10% within 8 weeks prior to study treatment
• •Current urinary tract or bladder infection
• •Drug, alcohol, anabolic steroid, or other substance abuse reported within the last year (subject reported)
• •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)
• •Weight less than 154 lbs/ 70 kg, or BMI ≥ 35
• •Unable to limit or avoid NSAIDs for 15 days prior to treatment (subject reported)
• •Bleeding or clotting disorder, use of anticoagulant therapy, or history of easy or excessive bruising
• •Lab values for CBC, PT/PTT/INR, liver function and creatinine falling outside the normal lab values (see section 5.3 for further detail)
• •Systemic autoimmune disorder
• •Significant active systemic or localized infection
• •Receiving immunosuppressant medications, including corticosteroids
• •No prior regenerative medicine treatments or therapies
• •Currently taking nitroglycerine (NTG) or other nitrate medication (such as isosorbide)
• •Subjects who experience angina after taking PDE-5 inhibitors
• •Any other condition, which, in the opinion of the Investigator, would contraindicate treatment, affect compliance, interfere with study evaluations, limit study participation, contraindicate sexual activity, or confound the interpretation of study results (e.g., clinical diagnosis of penile fibrosis, allergy to tumescence fluid or components of collagenase, cell therapy, change in alpha blocker drug therapy, sickle cell disease)