NCT05776277

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

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 Obstetric Anal Sphincter Injury (DigniFI)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Cook MyoSite · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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).

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
BIOLOGICAL	Iltamiocel	Single external anal sphincter (EAS) injection of 300 x 10\^6 cells.
OTHER	Placebo	Placebo control is the vehicle solution used for the study product.

Timeline

• Start date: 2024-03-21
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2023-03-20
• Last updated: 2026-03-13

Locations

25 sites across 1 country: United States

Regulatory

• FDA-regulated drug study