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

Sponsor

Cook MyoSite (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05776277

Collaborator

(none)

200

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fecal Incontinence	Biological: Iltamiocel Other: Placebo	Phase 3

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Two-stage, Randomized, Controlled Trial Comparing the Safety and Efficacy of Iltamiocel With Placebo in the Treatment of Female Subjects With Chronic Fecal Incontinence and a History of Obstetric Anal Sphincter Injury (DigniFI)

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2026

Anticipated Study Completion Date :

Sep 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Iltamiocel	Biological: Iltamiocel Single external anal sphincter (EAS) injection of 300 x 10^6 cells.
Placebo Comparator: Placebo	Other: Placebo Placebo control is the vehicle solution used for the study product.

Arm

Intervention/Treatment

Experimental: Iltamiocel

Biological: Iltamiocel

Single external anal sphincter (EAS) injection of 300 x 10^6 cells.

Placebo Comparator: Placebo

Other: Placebo

Placebo control is the vehicle solution used for the study product.

Outcome Measures

Primary Outcome Measures

Changes in frequency of fecal incontinence episodes. [12 Months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult female ≥ 18 years of age who has primary symptoms of fecal incontinence (FI) for at least 12 months.
History of obstetric anal sphincter injury (e.g., episiotomy, perineal tear).
Failed conservative treatment (e.g., dietary modification, antidiarrheal medications, pelvic floor muscle training, biofeedback) for at least 6 months prior to enrollment.
Has a Cleveland Clinic Incontinence Score (CCIS) ≥9 at baseline.
Must be willing and able to comply with the study procedures, be mentally competent and able to understand all study requirements, and must agree to read and sign the informed consent form prior to any study-related procedures.

Exclusion Criteria:

Actively undergoing treatment with stimulation neuromodulation system (sacral, tibial, or percutaneous tibial nerve stimulation) within the last 6 months or planned during the course of the study.
Is pregnant or planning to become pregnant within the next 2 years.
Has known rectal sensory dysfunction (e.g., hypersensitivity or hyposensitivity).
Has an obstetric anal sphincter injury (e.g., episiotomy, perineal tear) within 1 year previous to study enrollment.
Patient BMI ≥ 35.
Has a history of cancer in the colorectal or pelvic organs within 5 years prior to study enrollment.
Any cancer that has undergone treatment within the past 12 months.
Has an established diagnosis of inflammatory bowel disease (Crohn's disease, ulcerative colitis) or current intestinal stoma.
Has grade III/IV hemorrhoids.
Has a history of chronic diarrhea.
Has significant pelvic floor prolapse, significant genitourinary prolapse beyond the introitus, significant symptomatic rectocele, or evidence of significant rectal evacuation disorder leading to post-defecatory leakage.