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)
1 other identifier
interventional
200
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2024
Typical duration for phase_3
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2023
CompletedFirst Posted
Study publicly available on registry
March 20, 2023
CompletedStudy Start
First participant enrolled
March 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
March 13, 2026
March 1, 2026
2.7 years
March 8, 2023
March 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in frequency of fecal incontinence episodes.
12 Months
Study Arms (2)
Iltamiocel
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cook MyoSitelead
Study Sites (25)
UC San Diego Health
La Jolla, California, 92122, United States
UC Irvine Medical Center
Orange, California, 92868, United States
University of California, San Francisco - Center for Colorectal Surgery
San Francisco, California, 94158, United States
Prestige Medical Group
Tustin, California, 92780, United States
American Association of Female Pelvic Medicine
Westlake Village, California, 91361, United States
University of Florida Shands Hospital
Gainesville, Florida, 32610, United States
Healthcare Clinical Data, Inc.
Miami, Florida, 33161, United States
Orlando Health Colon & Rectal Institute
Orlando, Florida, 32806, United States
USF Health South Tampa Center for Advanced Healthcare
Tampa, Florida, 33606, United States
Colorectal Wellness Center
Fayetteville, Georgia, 30214, United States
University of Illinois
Chicago, Illinois, 60612, United States
Franciscan Health Indianapolis
Indianapolis, Indiana, 46237, United States
Ochsner Health
New Orleans, Louisiana, 70121, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Bennett Institute of Urogynecology and Incontinence
Grand Rapids, Michigan, 49546, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Rutgers, Robert Wood Johnson Medical School, Clinical Research Center
New Brunswick, New Jersey, 08901, United States
Westchester Medical Center
Hawthorne, New York, 10532, United States
The Mount Sinai Medical Center
New York, New York, 10029, United States
Weill Cornell Medicine
New York, New York, 10065, United States
Stony Brook University Hospital
Stony Brook, New York, 11794, United States
Cleveland Clinic Main Campus Crile Building
Cleveland, Ohio, 44195, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ron Jankowski, PhD
Cook Myosite, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2023
First Posted
March 20, 2023
Study Start
March 21, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2027
Last Updated
March 13, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share