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

This study is currently recruiting participants.
Verified November 2013 by Tissue Genesis, Inc.
Sponsor:
Information provided by (Responsible Party):
Tissue Genesis, Inc.
ClinicalTrials.gov Identifier:
NCT01601353
First received: May 9, 2012
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention
Erectile Dysfunction
Device: Tissue Genesis Cell Isolation System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Tissue Genesis, Inc.:

Primary Outcome Measures:
  • Adverse Events that occur during or after the procedure to measure safety and tolerability [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Erectile function [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Continence [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Treatment assessment [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Erection hardness [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01601353

Contacts
Contact: Mike Winegar 763-639-0700 mwinegar@tissuegenesis.com

Locations
United States, California
San Diego Sexual Medicine Recruiting
San Diego, California, United States, 92120
Contact: TBD    619-265-8865      
Principal Investigator: Irwin Goldstein, MD         
Sponsors and Collaborators
Tissue Genesis, Inc.
  More Information

No publications provided

Responsible Party: Tissue Genesis, Inc.
ClinicalTrials.gov Identifier: NCT01601353     History of Changes
Other Study ID Numbers: ED1001
Study First Received: May 9, 2012
Last Updated: November 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Tissue Genesis, Inc.:
Erectile Dysfunction

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014