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Adaptive Design Study of Autologous Muscle Derived Cells Compared to Placebo for Female Urinary Sphincter Repair for Persistent or Recurrent Stress Urinary Incontinence Following Surgical Treatment
Trial ID: NCT03104517
This study evaluates the efficacy and safety of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR; generic name: iltamiocel) compared to a placebo in the reduction of stress incontinence episode frequency in adult female patients with post-surgical persistent or recurrent stress urinary incontinence (SUI). Half of the participants will receive AMDC-USR (injections with cells) and the other half will receive placebo.
CELLEBRATE: An Adaptive, Two-Stage, Double-Blind, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR With Placebo in Female Subjects With Persistent or Recurrent Stress Urinary Incontinence Following Surgical Treatment
- 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 be willing and able to comply with the study procedures, be mentally competent
and able to understand all study requirements, and must agree to read and sign the
informed consent form prior to any study-related procedures.
- Must have completed 100% of the screening 3-day diary evening reports.
- Patient has symptoms of only urge incontinence as confirmed by basic evaluation of
etiology from a patient medical history, including a focused incontinence history.
- Patient has symptoms of mixed urinary incontinence where urge incontinence is the
- Patient has had stress urinary incontinence symptoms less than 6 months prior to
signing the informed consent.
- Patient has not previously attempted conservative treatment prior to signing the
informed consent. (Examples of conservative treatment include behavior modifications,
bladder exercises, biofeedback, pelvic floor muscle therapy, etc.)
- Patient BMI ≥ 35.
- Patient routinely has more than 2 episodes of awakening to void during normal sleeping
- If taking a medication known to affect lower urinary tract function, including but not
limited to, anticholinergics, beta 3 adrenergic receptor agonists, tricyclic
antidepressants, serotonin-norepinephrine reuptake inhibitor (SNRI) or selective
serotonin reuptake inhibitor (SSRI) antidepressants, diuretics, or alpha-adrenergic
blockers, patient cannot be maintained on a stable dose and/or frequency of medication
(including diuretics), cannot be maintained on a stable dose and/or frequency for at
least 2 weeks prior to screening or is likely to change during the course of the
- History of cancer in pelvic organs, ureters, or kidneys.
- Patient is pregnant, lactating, or plans to become pregnant during the course of the
biological: AMDC-USR (iltamiocel)