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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03518333
Recruitment Status : Not yet recruiting
First Posted : May 8, 2018
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Tissue Genesis, LLC

Tracking Information
First Submitted Date  ICMJE April 24, 2018
First Posted Date  ICMJE May 8, 2018
Last Update Posted Date October 14, 2019
Estimated Study Start Date  ICMJE December 1, 2019
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2018)
Primary Efficacy Objective: ability of adipose derived cells to restore erectile function using the 6-Item IIEF-EF score [ Time Frame: 6 months ]
Evaluate the ability of adipose derived cells to restore erectile function at 6 months using the 6-Item IIEF-EF score
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2018)
Safety Objective: assessment of any adverse events [ Time Frame: 12 months ]
Will be evaluated by the IDMC through assessment of any adverse events that occur during or after adipose tissue harvest and intracorporal injection of adipose derived cells through 12-month follow-up. All adverse events will be reviewed by the IDMC and the Sponsor at least every 3 months throughout enrollment, and at least annually throughout study follow-up.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Tissue Genesis Icellator Cell Isolation System to Treat Erectile Dysfunction
Official Title  ICMJE Evaluation of the Tissue Genesis Icellator Cell Isolation System to Treat Erectile Dysfunction
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).
Detailed Description

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. The two randomized study arms are:

  1. Treatment with SVF followed six months later with sham treatment (ARM 1)
  2. Sham treatment followed six months later by treatment with SVF (ARM 2) Study population is 60 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. Subjects will be followed for 12 months after initial treatment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
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.
Masking: Single (Participant)
Masking Description:
Sham treatment
Primary Purpose: Treatment
Condition  ICMJE Erectile Dysfunction
Intervention  ICMJE Device: Injection of adipose derived cells into penis
Injection of Icellator-derived cells
Other Name: Sham control intervention of injection of saline into penis
Study Arms  ICMJE
  • Experimental: ARM 1
    Injection of adipose derived cells into penis followed six months later with sham control saline injection procedure
    Intervention: Device: Injection of adipose derived cells into penis
  • Experimental: ARM 2
    Sham control saline injection procedure followed six months later by injection of adipose derived cells into penis
    Intervention: Device: Injection of adipose derived cells into penis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 4, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2021
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: 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.
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Paul Kosnik, PhD 808-539-9331 pkosnik@tissuegenesis.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03518333
Other Study ID Numbers  ICMJE ED1002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tissue Genesis, LLC
Study Sponsor  ICMJE Tissue Genesis, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Paul Kosnik, PhD Sponsor GmbH
PRS Account Tissue Genesis, LLC
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP