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

Launched by COOK MYOSITE · Mar 8, 2023

Keywords

ClinConnect Summary

This clinical trial is examining the effectiveness and safety of a treatment called iltamiocel for women suffering from chronic fecal incontinence, which is the inability to control bowel movements. Specifically, the study is looking at women who have experienced an injury to the muscles around the anus during childbirth. Participants in the trial will receive either a single injection of iltamiocel, which contains live cells aimed at improving bowel control, or a placebo, which is a harmless substance that looks like the treatment but does not have any active ingredients. The goal is to see if the injection can reduce the number of fecal incontinence episodes that these women experience.

To be eligible for the trial, women must be at least 18 years old and have had symptoms of fecal incontinence for at least a year. They should also have a history of anal sphincter injury from childbirth and must not have found relief from other treatments like changes in diet or pelvic floor exercises. Participants will need to be willing to follow the study procedures and provide informed consent. Throughout the trial, participants can expect regular check-ins to monitor their progress and any effects from the treatment. This study is currently recruiting participants, and it's an important step towards finding better options for women dealing with this challenging condition.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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.
• • 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.
• Exclusion Criteria:
• • 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 ≥ 38.
• • 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.