Clinical trial NCT05776277: Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Fecal Incontinence
Keywords: Obstetric Trauma
Obstetric Injury
Cell Therapy
Anal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Bowel Incontinence
Lead sponsor: Cook MyoSite
Sponsor class: INDUSTRY
First posted: 2023-03-20
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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.
* 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 ≥ 38.
* 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.

Primary outcomes:
measure: Changes in frequency of fecal incontinence episodes.
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego Health
state: California
city: Orange
country: United States
facility: UC Irvine Medical Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco - Center for Colorectal Surgery
state: California
city: Tustin
country: United States
facility: Prestige Medical Group
state: California
city: Westlake Village
country: United States
facility: American Association of Female Pelvic Medicine
state: California
city: Gainesville
country: United States
facility: University of Florida Shands Hospital
state: Florida
city: Miami
country: United States
facility: Healthcare Clinical Data, Inc.
state: Florida
city: Orlando
country: United States
facility: Orlando Health Colon & Rectal Institute
state: Florida
city: Tampa
country: United States
facility: USF Health South Tampa Center for Advanced Healthcare
state: Florida
city: Fayetteville
country: United States
facility: Colorectal Wellness Center
state: Georgia
city: Chicago
country: United States
facility: University of Illinois
state: Illinois
city: Indianapolis
country: United States
facility: Franciscan Health Indianapolis
state: Indiana
city: New Orleans
country: United States
facility: Ochsner Health
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Grand Rapids
country: United States
facility: Corewell Health
state: Michigan
city: Grand Rapids
country: United States
facility: Bennett Institute of Urogynecology and Incontinence
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New Brunswick
country: United States
facility: Rutgers, Robert Wood Johnson Medical School, Clinical Research Center
state: New Jersey
city: Hawthorne
country: United States
facility: Westchester Medical Center
state: New York
city: New York
country: United States
facility: The Mount Sinai Medical Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus Crile Building
state: Ohio
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Cook Myosite, Inc.
name: Ron Jankowski, PhD
role: STUDY_DIRECTOR
References: