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

Cook MyoSite (Industry)
Overall Status
Not yet recruiting
CT.gov ID

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
  • 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:
Anticipated Enrollment :
200 participants
Intervention Model:
Parallel Assignment
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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.

Contacts and Locations


No locations specified.

Sponsors and Collaborators

  • Cook MyoSite


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Cook MyoSite
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • 22-01
First Posted:
Mar 20, 2023
Last Update Posted:
Mar 20, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Cook MyoSite
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 20, 2023