Evaluation of the Tissue Genesis Icellator Cell Isolation System to Treat Erectile Dysfunction

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Erectile Dysfunction

In brief

This clinical study is designed to investigate the safety and potential ability of relocated autologous SVF (stromal vascular fraction) to restore erectile function in men with ED (erectile dysfunction).

Key facts

Study ID: NCT03518333
Run by: Tissue Genesis
People needed: 60
Starts: 2022-04-01
Expected to finish: 2023-09-01
Last updated by the study team: 2021-06-24

Who can join

Age: 21 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

Willing and able to provide written informed consent
Chronic, organic ED, duration at least 0.5 years, with baseline IIEF-EF score of 11-22
Willing to complete a 6-item erectile function questionnaire (IIEF-EF), a 4-week diary of sexual encounters (a single-item erection hardness assessment (EHS) and SEP-2 and SEP-3), 3 erectile function treatment Global Assessment Questions (GAQs), and 3 continence questions within 8 weeks before study treatment (baseline- except GAQs), and at each of the follow-up time points: 6 weeks (excluding EHS, SEP-2, SEP-3, and NPT), and 3, 6, 9, and 12 months after study treatment/ randomization
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)
Willing to limit alcohol intake and eliminate use of recreational drugs for sexual encounters
Willing to undergo two minor surgical procedure (small-volume liposuction, totaling approximately 60 - 120 cc) and two treatments of an injection of up to 30 cc of autologous SVF (or saline) into the corpora cavernosa over a 2- to 4-minute period, with a compression band applied at the base of the penis for total duration of up to 15 minutes
Abdominal area amenable to two liposuction of at least 60-120 cc each 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, or PSA > 0 after radical prostatectomy
Previous pelvic or abdominal radiation therapy
Anti-androgen therapy within the last 12 months or anti-androgen therapy of greater than 6 months in duration
Untreated hypogonadism or low serum total testosterone (< 300 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)
Any previous penile implant or penile vascular surgery
Current or previous malignancy other than localized prostate cancer or non-abdominal, non-melanoma skin cancer (successfully treated or treatable by curative excision or other local curative therapy- abdominal skin cancer is exclusionary)
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 > 10% within 8 weeks prior to study treatment
Current urinary tract or bladder infection
Drug, alcohol, anabolic steroid, or other substance abuse reported within the last year (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 ≥ 35
Unable to limit or avoid 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 CBC, PT/PTT/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, including corticosteroids
No prior regenerative medicine treatments or therapies
Currently taking nitroglycerine (NTG) or other nitrate medication (such as isosorbide)
Subjects who experience angina after taking PDE-5 inhibitors
Any other condition, which, in the opinion of the Investigator, would contraindicate treatment, affect compliance, interfere with study evaluations, limit study participation, contraindicate sexual activity, or confound the interpretation of study results (e.g., clinical diagnosis of penile fibrosis, allergy to tumescence fluid or components of collagenase, cell therapy, change in alpha blocker drug therapy, sickle cell disease)

Where it is running

San Diego Sexual Medicine — San Diego, California, United States
James A. Simon — Washington D.C., District of Columbia, United States
University of Florida — Gainesville, Florida, United States
Johns Hopkins Kimmel Cancer Center — Baltimore, Maryland, United States
Scott Department of Urology, Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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