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Erectile DysfunctionNCT01601353

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

A study testing Tissue Genesis Cell Isolation System in people with Erectile Dysfunction, run by Tissue Genesis at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 40 to 70 years, men only
Conditions the study is for
Erectile Dysfunction
What is being tested?
Tissue Genesis Cell Isolation System
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesUnited States
Study dates
May 2012to Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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.

Who cannot join

  • 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))
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  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Baylor College of Medicine

    Houston, Texas, 77030

  • San Diego Sexual Medicine

    San Diego, California, 92120

Other trials in United States

About this study

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

Read the 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.

Being tested
Tissue Genesis Cell Isolation System
Keywords
Erectile Dysfunction
Medical subject headings
Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tissue Genesis Cell Isolation SystemDevice

    Liposuction followed by injection of autologous adipose derived cells

Study groups in NCT01601353
Study groupRoleWhat they receive
TreatmentExperimentalInjection of adipose derived cells into penis
Receives: Device: Tissue Genesis Cell Isolation System
ControlNo interventionNo intervention through 9 months

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events that occur during or after the procedure to measure safety and tolerability

    Measured: 3 years

  2. Erectile function

    Measured: 6 months

Secondary outcomes (3)

  1. Continence

    Measured: 3 years

  2. Treatment assessment

    Measured: 3 years

  3. Erection hardness

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionAug 2018
  4. Study completionAug 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01601353
Sponsor's protocol ID
ED1001
Status last verified
Jun 2021
First submitted
9 May 2012
Last updated
24 Jun 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25974235

Questions about this trial

What is this clinical trial studying?

A study testing Tissue Genesis Cell Isolation System in people with Erectile Dysfunction, run by Tissue Genesis at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events that occur during or after the procedure to measure safety and tolerability (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01601353, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2021.

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