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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01601353
Recruitment Status : Unknown
Verified June 2021 by Tissue Genesis.
Recruitment status was:  Active, not recruiting
First Posted : May 18, 2012
Last Update Posted : June 24, 2021
Information provided by (Responsible Party):
Tissue Genesis

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

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Device: Tissue Genesis Cell Isolation System Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluate the Use of Liposuction and Cell Separation Devices for Autologous Fat (Adipose) Derived Cells to Treat the Symptoms of Erectile Dysfunction
Actual Study Start Date : May 2012
Actual Primary Completion Date : August 2018
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Treatment
Injection of adipose derived cells into penis
Device: Tissue Genesis Cell Isolation System
Liposuction followed by injection of autologous adipose derived cells

No Intervention: Control
No intervention through 9 months

Primary Outcome Measures :
  1. Adverse Events that occur during or after the procedure to measure safety and tolerability [ Time Frame: 3 years ]
  2. Erectile function [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Continence [ Time Frame: 3 years ]
  2. Treatment assessment [ Time Frame: 3 years ]
  3. Erection hardness [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01601353

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United States, California
San Diego Sexual Medicine
San Diego, California, United States, 92120
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Tissue Genesis
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tissue Genesis
ClinicalTrials.gov Identifier: NCT01601353    
Other Study ID Numbers: ED1001
First Posted: May 18, 2012    Key Record Dates
Last Update Posted: June 24, 2021
Last Verified: June 2021
Keywords provided by Tissue Genesis:
Erectile Dysfunction
Additional relevant MeSH terms:
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Erectile Dysfunction
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Sexual Dysfunction, Physiological
Male Urogenital Diseases
Sexual Dysfunctions, Psychological
Mental Disorders