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Cell-Based Therapy for Stress Urinary Incontinence (CELLEBRATE Trial)
CELLEBRATE Trial Summary
This trial will test whether or not a cell-based therapy can help reduce stress incontinence episodes in adult women who have had surgery for stress urinary incontinence.
CELLEBRATE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCELLEBRATE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CELLEBRATE Trial Design
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Who is running the clinical trial?
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- I am a woman over 18 with severe bladder control issues for 6+ months.My BMI is 35 or higher.I have had surgery for stress urinary incontinence before.I mainly experience sudden urges to urinate that I cannot control.I have experienced stress urinary incontinence for less than 6 months.My medication for urinary tract issues has been stable for at least 2 weeks.I am willing and able to follow the study's procedures and understand all its requirements.I only experience sudden urges to urinate that I cannot control.You wake up to pee more than twice during the night.I have not tried any non-surgical treatments for my condition before signing up.I have had cancer in my pelvic area, ureters, or kidneys.
- Group 1: AMDC-USR (iltamiocel)
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are the patients in this trial all 18 years or older?
"Eligible patients for this study must be aged 18 to 75. However, if the patient is under 18 years old, there are 19 other trials that they may participate in. For seniors (over 65 years old), there are 139 other studies available."
Has the FDA cleared AMDC-USR for public consumption?
"Our team at Power believes that AMDC-USR is safe to use, and rates it a 3 on a scale of 1 to 3. This is because Phase 3 trials have shown some efficacy, as well as multiple rounds of data supporting safety."
Could you inform me as to how many different locations are conducting this trial at the moment?
"This clinical trial is taking place at 13 different locations, with notable hospitals like University of Colorado Hospital in Aurora and UCLA Women's Health Clinical Research Unit/Department of OBGYN in Los Angeles participating."
Could I participate in this clinical research if I qualify?
"This trial is seeking 260 patients that suffer from enuresis and meet the following additional criteria: Must have completed 100% of the screening 3-day diary evening reports, Adult female patient ≥ 18 years of age who has primary and moderate-to-severe symptoms of SUI for at least 6 months, as confirmed by patient medical history and clinical symptoms, including a focused incontinence evaluation., History of previous surgery for treatment of SUI. Previous surgery could include midurethral sling, retropubic suspension, or bladder neck sling. Bulking agents alone are not considered previous surgery for treatment of SUI., Must"
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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