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

NCT03518333 | Unknown DMC FDA Device

• 1 other identifier: ED1002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

Brief Summary

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).

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• Primary Efficacy Objective: ability of adipose derived cells to restore erectile function using the 6-Item IIEF-EF score

  Evaluate the ability of adipose derived cells to restore erectile function at 6 months using the 6-Item IIEF-EF score

  6 months

Secondary Outcomes (1)

• Safety Objective: assessment of any adverse events

  12 months

Study Arms (2)

ARM 1

EXPERIMENTAL

Injection of adipose derived cells into penis followed six months later with sham control saline injection procedure

Device: Injection of adipose derived cells into penis

ARM 2

EXPERIMENTAL

Sham control saline injection procedure followed six months later by injection of adipose derived cells into penis

Device: Injection of adipose derived cells into penis

Interventions

Injection of adipose derived cells into penis DEVICE

Injection of Icellator-derived cells

Also known as: Sham control intervention of injection of saline into penis

ARM 1; ARM 2

Eligibility Criteria

• Age: 21 Years+
• Gender Eligibility Details: Adult male subjects with organic erectile dysfunction (IIEF-EF score 11-22) of greater than 6 months' duration due to radical prostatectomy, diabetes mellitus, and/or vascular disease.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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)

Sponsors & Collaborators

• Tissue Genesis: lead

Study Sites (5)

San Diego Sexual Medicine

San Diego, California, 92120, United States

Location

James A. Simon

Washington D.C., District of Columbia, 20036, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Johns Hopkins Kimmel Cancer Center

Baltimore, Maryland, 21287, United States

Location

Scott Department of Urology, Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Paul Kosnik, PhD

  Sponsor GmbH

  STUDY CHAIR

Central Study Contacts

Paul Kosnik, PhD

CONTACT

808-539-9331; pkosnik@tissuegenesis.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Sham treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multi-center, two-arm, blinded, randomized treatment. Covariate adaptive randomization will be used. Covariates included in the adaptive randomization process will be investigational center, history of diabetes, and radical prostatectomy.

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: May 8, 2018
• Study Start: April 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: September 1, 2023
• Last Updated: June 24, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)