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. Investigational means it is not approved by the U.S. Food and Drug Administration (FDA). 
   
The purpose of this study is to evaluate the safety and efficacy of Iltamiocel in treating chronic fecal incontinence (FI), which is the unintended loss of liquid or solid stool occurring for at least 6 months. Injection with the study product involves a medical procedure in which the participants' muscle cells are collected from their thigh (biopsy), processed to grow a specific type of muscle repair cell, and then injected into the tissues of their anus. It is believed these cells become part of the tissue where they have been injected. This study will determine if the cells are safe and effective in treating chronic FI in adult women. 
   
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 the injection with placebo will have the option to receive an injection with their cells after completion of the blinded portion of their study participation.

Total study participation will last approximately 12 months.