Cell-Based Therapy for Stress Urinary Incontinence
(CELLEBRATE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment for women who still have urine leakage after surgery. The treatment uses their own muscle cells, which are injected into the urinary passage to help strengthen it. The goal is to reduce accidental urine leakage during activities like laughing or coughing. Muscle-derived cells have been previously used in treatments for urinary incontinence, showing promise in improving urethral closure and reducing symptoms.
Do I have to stop taking my current medications for the trial?
You may need to stop or adjust your current medications if they affect lower urinary tract function. If you are taking such medications, you must be on a stable dose for at least 2 weeks before the trial and maintain it during the study.
Will I have to stop taking my current medications?
The trial requires that if you are taking medications that affect urinary function, like certain antidepressants or diuretics, you must be on a stable dose for at least 2 weeks before screening and throughout the study. If you can't maintain a stable dose, you may need to stop or adjust your medication.
What safety data is available for cell-based therapy for stress urinary incontinence?
The safety data for cell-based therapy, specifically autologous muscle-derived cells (AMDC), for stress urinary incontinence indicates that the treatment is generally safe. Multiple studies, including double-blind, randomized, placebo-controlled trials, have been conducted to assess the safety and efficacy of AMDC. These studies report no serious procedure or treatment-related adverse events. In trials for underactive bladder, which also used AMDC, no study-related adverse events or side effects were reported, and the treatment was described as safe and minimally invasive. Overall, the existing safety data suggests that AMDC therapy is a promising and safe treatment option for urinary incontinence.12345
Is cell-based therapy for stress urinary incontinence safe?
Is the treatment AMDC-USR (iltamiocel) a promising treatment for stress urinary incontinence?
Yes, AMDC-USR (iltamiocel) is a promising treatment for stress urinary incontinence. Studies show it can help repair the urinary sphincter muscle, reduce incontinence episodes, and improve muscle function. This cell-based therapy offers hope for those who haven't found success with other treatments.12367
How is the treatment AMDC-USR (iltamiocel) different from other treatments for stress urinary incontinence?
AMDC-USR (iltamiocel) is unique because it uses autologous muscle-derived cells, which are cells taken from the patient's own muscle, to repair the urinary sphincter. This cell-based therapy aims to regenerate the sphincter muscle, offering a novel approach compared to traditional treatments like physical exercises or medications.12367
What data supports the idea that Cell-Based Therapy for Stress Urinary Incontinence is an effective treatment?
The available research shows that Cell-Based Therapy for Stress Urinary Incontinence, specifically using autologous muscle-derived cells, is effective. One study found that these cells helped repair the urinary sphincter in women with stress urinary incontinence. Another study showed that injections of these cells reduced the frequency of stress incontinence episodes. Additionally, in animal studies, this therapy improved the function of the urethral sphincter, which is important for controlling urination. Compared to other treatments, this cell-based approach directly targets the muscles involved in urinary control, potentially offering a more direct and effective solution.12689
What data supports the effectiveness of the treatment for stress urinary incontinence?
Research shows that autologous muscle-derived cells (AMDC) can help repair the urinary sphincter, reducing stress urinary incontinence episodes. Studies also indicate that similar cell-based therapies have improved muscle function in both animal models and human trials, suggesting potential benefits for this condition.12689
Who Is on the Research Team?
Melissa Kaufman, M.D., Ph.D.
Principal Investigator
Vanderbilt University Medical Center, Department of Urologic Surgery
Are You a Good Fit for This Trial?
This trial is for adult women over 18 who have moderate-to-severe stress urinary incontinence despite having surgery for it. They must not be pregnant, planning pregnancy, or breastfeeding, and should not have a BMI of 35 or higher. Participants need to have tried other treatments like pelvic exercises and cannot be on certain medications affecting the bladder.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive injections of either AMDC-USR or placebo for urinary sphincter repair
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants who received placebo may opt to receive an injection with their cells after the blinded portion
What Are the Treatments Tested in This Trial?
Interventions
- AMDC-USR (iltamiocel)
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cook MyoSite
Lead Sponsor