Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury

Open to females ages 18 years and up

• Adult female ≥ 18 years of age who has primary symptoms of fecal incontinence (FI) for at least 12 months.
• History of obstetric anal sphincter injury (e.g., episiotomy, perineal tear).
• Failed conservative treatment (e.g., dietary modification, antidiarrheal medications, pelvic floor muscle training, biofeedback) for at least 6 months prior to enrollment.
• Has a Cleveland Clinic Florida Incontinence Score (CCFIS) ≥9 at Baseline.
• 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.

• Has an implanted stimulation neuromodulation system (sacral or tibial) and symptoms are unstable as determined by the physician.
• Is pregnant or planning to become pregnant within the next 2 years.
• Has known rectal sensory dysfunction (e.g., hypersensitivity or hyposensitivity).
• Has an obstetric anal sphincter injury (e.g., episiotomy, perineal tear) within 1 year previous to study enrollment.
• Patient BMI ≥ 35.
• Has a history of cancer in the colorectal or pelvic organs within 5 years prior to study enrollment.
• Any cancer that has undergone treatment within the past 12 months.
• Has an established diagnosis of inflammatory bowel disease (Crohn's disease, ulcerative colitis) or current intestinal stoma.
• Has grade III/IV hemorrhoids.
• Has chronic diarrhea at the time of Screening.
• Has chronic constipation at the time of Screening.
• Has significant pelvic floor prolapse, significant genitourinary prolapse beyond the introitus, significant symptomatic rectocele, or evidence of significant rectal evacuation disorder leading to post-defecatory leakage.