Chronic fecal incontinence (FI) is the recurrent unintended passage of mucus and/or liquid or solid stool for at least 6 months. Iltamiocel is an investigational cell therapy product that involves a medical procedure in which a participant's own muscle cells are collected, processed, and then injected into the tissues of the external anal sphincter.
This is a double-blind randomized study, which means neither the participant, nor the study doctor will know which treatment group the participant will be in. Participants who are randomly chosen to receive injection with placebo will have the option to receive an injection with their cells after completion of the blinded portion of their study participation (12 months).
