Erectile DysfunctionNCT03518333
Evaluation of the Tissue Genesis Icellator Cell Isolation System to Treat Erectile Dysfunction
A study testing Injection of adipose derived cells into penis in people with Erectile Dysfunction, run by Tissue Genesis at 5 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Injection of adipose derived cells into penis
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Apr 2022to 1 Sep 2023
- 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 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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)
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- 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)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins Kimmel Cancer Center
Baltimore, Maryland, 21287
Sandy Moore Cooper, 443-287-0385, mooresa@jhmi.edu
University of Florida
Gainesville, Florida, 32610
Sarah Long, RN, 352-273-8932, Sarah.Long@medicine.ufl.edu
Keith March, MD, PhD
Scott Department of Urology, Baylor College of Medicine
Houston, Texas, 77030
Boriss Losso, MS, 713-798-4396, boriss.losso@bcm.edu
Mohit Khera, MD, MBA, MPH
San Diego Sexual Medicine
San Diego, California, 92120
Sue Goldstein, 619-265-8865, suegoldstein@gmail.com
Irwin Goldstein, MD
James A. Simon
Washington D.C., District of Columbia, 20036
Vanessa Lukas, 202-293-1000, vlukas@jamesasimonmd.com
Rachel Rubin, MD
About this study
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).
Read the 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:
- Treatment with SVF followed six months later with sham treatment (ARM 1)
- 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.
- Conditions
- Erectile Dysfunction
- Being tested
- Injection of adipose derived cells into penis
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of adipose derived cells into penisDevice
Also called Sham control intervention of injection of saline into penis
Injection of Icellator-derived cells
| Study group | Role | What they receive |
|---|---|---|
| ARM 1 | Experimental | Injection of adipose derived cells into penis followed six months later with sham control saline injection procedure Receives: 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 Receives: Device: Injection of adipose derived cells into penis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (1)
Safety Objective: assessment of any adverse events
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start1 Apr 2022 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 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 blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tissue Genesis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Kosnik, PhD, Study chair, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518333
- Sponsor's protocol ID
- ED1002
- Status last verified
- Jun 2021
- First submitted
- 24 Apr 2018
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Tissue Genesis Icellator Cell Isolation System to Treat Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT03518333
- Acronym / sponsor ID
- ED1002
- Conditions
- Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tissue GenesisIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 8 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Treatment with SVF followed six months later with sham treatment (ARM 1)
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ARM 1 | Experimental | Device: Injection of adipose derived cells into penisInjection of adipose derived cells into penis followed six months later with sham control saline injection procedure |
| ARM 2 | Experimental | Device: Injection of adipose derived cells into penisSham control saline injection procedure followed six months later by injection of adipose derived cells into penis |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injection of adipose derived cells into penisAlso: Sham control intervention of injection of saline into penisInjection of Icellator-derived cells | Device | ARM 1, ARM 2 |
Primary outcome
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
1 secondary outcome
Safety Objective: assessment of any adverse events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Kosnik, PhD study chair
Sponsor GmbH
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection of adipose derived cells into penis in people with Erectile Dysfunction, run by Tissue Genesis at 5 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 10 inclusion and 25 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 5 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?
Contact Paul Kosnik, PhD (808-539-9331, pkosnik@tissuegenesis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Objective: ability of adipose derived cells to restore erectile function using the 6-Item IIEF-EF score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.