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First received: March 08, 2023

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

Study Status: Completed

Recruit Status: RECRUITING

Condition: Fecal Incontinence

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.

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