Evaluate the Use of Liposuction and Cell Separation Devices for Autologous Fat (Adipose) Derived Cells to Treat the Symptoms of Erectile Dysfunction
1 other identifier
interventional
30
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2012
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 9, 2012
CompletedFirst Posted
Study publicly available on registry
May 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedJune 24, 2021
June 1, 2021
6.3 years
May 9, 2012
June 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Adverse Events that occur during or after the procedure to measure safety and tolerability
3 years
Erectile function
6 months
Secondary Outcomes (3)
Continence
3 years
Treatment assessment
3 years
Erection hardness
3 years
Study Arms (2)
Treatment
EXPERIMENTALInjection of adipose derived cells into penis
Control
NO INTERVENTIONNo intervention through 9 months
Interventions
Liposuction followed by injection of autologous adipose derived cells
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tissue Genesislead
Study Sites (2)
San Diego Sexual Medicine
San Diego, California, 92120, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Related Publications (1)
Khera M, Albersen M, Mulhall JP. Mesenchymal stem cell therapy for the treatment of erectile dysfunction. J Sex Med. 2015 May;12(5):1105-6. doi: 10.1111/jsm.12871. No abstract available.
PMID: 25974235DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2012
First Posted
May 18, 2012
Study Start
May 1, 2012
Primary Completion
August 1, 2018
Study Completion
August 1, 2021
Last Updated
June 24, 2021
Record last verified: 2021-06