This clinical trial is focused on studying a condition known as fecal incontinence, which affects both men and women. Fecal incontinence is when a person has difficulty controlling their bowel movements, leading to unexpected leakage. The study is testing a new treatment called ICEF15, which involves using special cells taken from a patient’s own muscles, known as autologous Skeletal Derived Muscle Cells (aSDMC). These cells are injected into the muscles to help improve control over bowel movements.

The purpose of the study is to evaluate how effective and safe the ICEF15 treatment is for people with fecal incontinence caused by problems with the external anal sphincter, a muscle that helps control bowel movements. Participants in the study will receive either the ICEF15 treatment or a placebo, which is a solution that does not contain the active treatment. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo, to ensure unbiased results.

Throughout the study, participants will receive injections and will be monitored over a period of time to see if there is a reduction in the frequency of incontinence episodes. The study aims to determine if the treatment can reduce these episodes by at least 50% compared to before the treatment started. This research is important for finding new ways to help people manage fecal incontinence and improve their quality of life.