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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Fecal Incontinence
• Intervention / Treatment: Other: Placebo; Biological: Iltamiocel

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Heather Karabaich; Phone Number: 410-206-2840; Email: Heather.Karabaich@veristat.com
• Study Contact Backup: Name: Cook MyoSite; Email: DigniFIStudy@CookMyoSite.com

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • Active, not recruiting
      • UC Irvine Medical Center
    • Santa Ana, California, United States, 92705
      • Recruiting
      • Prestige Medical Group
      • Principal Investigator: Lamia Gabal, MD
  • Florida
    • Gainesville, Florida, United States, 32610
      • Recruiting
      • University of Florida Shands Hospital
      • Principal Investigator: Johan Nordenstam, MD
    • Miami, Florida, United States, 33161
      • Recruiting
      • Healthcare Clinical Data, Inc.
      • Principal Investigator: Steven Chavoustie, MD
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • University of Illinois
      • Principal Investigator: Alejandra M Perez-Tamayo, MD
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Recruiting
      • Ochsner Health
      • Principal Investigator: Jennifer Paruch, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Principal Investigator: Liliana Bordeianou, MD
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Recruiting
      • Corewell Health
      • Principal Investigator: James Ogilvie, MD
    • Grand Rapids, Michigan, United States, 49546
      • Recruiting
      • Bennett Institute of Urogynecology and Incontinence
      • Principal Investigator: Jason Bennett, MD
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Recruiting
      • Rutgers, Robert Wood Johnson Medical School, Clinical Research Center
      • Principal Investigator: Juana Hutchinson-Colas, MD
  • New York
    • Hawthorne, New York, United States, 10532
      • Recruiting
      • Westchester Medical Center
      • Principal Investigator: Cara L Grimes, MD
    • Stony Brook, New York, United States, 11794
      • Recruiting
      • Stony Brook University Hospital
      • Principal Investigator: Deborah Nagle, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Florida Incontinence Score (CCFIS) ≥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:

• Has an implanted stimulation neuromodulation system (sacral or tibial) and symptoms are unstable as determined by the physician.
• 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 chronic diarrhea at the time of Screening.
• Has chronic constipation at the time of Screening.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in frequency of fecal incontinence episodes.	12 Months

Collaborators and Investigators

• Sponsor: Cook MyoSite
• Investigators: Study Director: Ron Jankowski, PhD, Cook Myosite, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: March 8, 2023
• First Submitted That Met QC Criteria: March 8, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Cell Therapy; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Bowel Incontinence; Anal Incontinence; Obstetric Trauma; Obstetric Injury
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: 22-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No