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

Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL




Official Title: A Two-stage, Randomized, Controlled Trial Comparing the Safety and Efficacy of Iltamiocel With Placebo in the Treatment of Female Participants With Chronic Fecal Incontinence and a History of Obstetri

Brief Summary: This study evaluates the efficacy and safety of a single injection of iltamiocel (300 x 10^6 cells) compared to a placebo in the reduction of fecal incontinence episode frequency in adult female participants with chronic fecal incontinence and a history of obstetric anal sphincter injury.
Half of the participants will receive iltamiocel (injections with cells) and the other half will receive placebo.