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

Fecal Incontinence Clinical Trial

— DigniFI  

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 Obstetric Anal Sphincter Injury (DigniFI)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05776277
• Other study ID #: 22-01
• Status: Recruiting
• Phase: Phase 3
• Start date: March 21, 2024
• Est. completion date: September 2027

Study information

• Verified date: June 2024
• Source: Cook MyoSite
• Contact: Heather Karabaich
• Phone: 410-206-2840
• Email: Heather.Karabaich[@]veristat.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2027
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Illinois	Chicago	Illinois
United States	University of Florida Shands Hospital	Gainesville	Florida
United States	Bennett Institute of Urogynecology and Incontinence	Grand Rapids	Michigan
United States	Corewell Health	Grand Rapids	Michigan
United States	Westchester Medical Center	Hawthorne	New York
United States	Franciscan Health Indianapolis	Indianapolis	Indiana
United States	Healthcare Clinical Data, Inc.	Miami	Florida
United States	Rutgers, Robert Wood Johnson Medical School, Clinical Research Center	New Brunswick	New Jersey
United States	Ochsner Health	New Orleans	Louisiana
United States	UC Irvine Medical Center	Orange	California
United States	Stony Brook University Hospital	Stony Brook	New York
United States	Prestige Medical Group	Tustin	California

Sponsors (1)

Lead Sponsor	Collaborator
Cook MyoSite

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in frequency of fecal incontinence episodes.		12 Months