Evaluate the Use of Liposuction and Cell Separation Devices for Autologous Fat (Adipose) Derived Cells to Treat the Symptoms of Erectile Dysfunction

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of adipose derived cells for the treatment of erectile dysfunction symptoms.

Detailed Description
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This trial is being conducted to determine the safety and efficacy of injecting autologous adipose derived cells into the penis of men with erectile dysfunction. Subjects will be randomized into a treatment and control arm.

Official Title
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Evaluate the Use of Liposuction and Cell Separation Devices for Autologous Fat (Adipose) Derived Cells to Treat the Symptoms of Erectile Dysfunction

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Device: Tissue Genesis Cell Isolation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men aged 40 - 70 Willing and able to provide written informed consent 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 Willing to complete questionnaires 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) 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) Willing to limit alcohol intake and eliminate use of recreational drugs for sexual encounters Willing to undergo a minor surgical procedure and injection Abdominal area amenable to liposuction of at least 60-120 cc of adipose tissue based on Investigator examination Mentally competent and able to understand all study requirements (based on investigator assessment) Willing to be available for all baseline, treatment and follow-up examinations required by protocol Willing to forego participation in any other study throughout the duration of this study unless receiving prior approval by Sponsor. Exclusion Criteria: Evidence of prostate cancer which requires additional radiotherapy or other adjuvant therapy Previous pelvic or abdominal radiation therapy Previous, concomitant or scheduled use of anti-androgen therapy Untreated hypogonadism or low serum total testosterone (< 200 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)) 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 Any previous penile implant or penile vascular surgery 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) 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 > 8% within 8 weeks prior to study treatment Current urinary tract or bladder infection Drug, alcohol, or substance abuse reported within the last three years (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 ≥ 30 Unable to limit or avoid nonsteroidal anti-inflammatory drugs(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 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) Systemic autoimmune disorder Significant active systemic or localized infection Receiving immunosuppressant medications

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Injection of adipose derived cells into penis | Device: Tissue Genesis Cell Isolation System<br>* Liposuction followed by injection of autologous adipose derived cells<br>|
| No Intervention: Control<br>No intervention through 9 months | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events that occur during or after the procedure to measure safety and tolerability |  | 3 years | 
| Erectile function |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continence |  | 3 years | 
| Treatment assessment |  | 3 years | 
| Erection hardness |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erectile Dysfunction