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Injection of iltamiocel for treating chronic fecal incontinence in women with obstetric injury

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)

Phase 3 Interventional Cook MyoSite · NCT05776277

This study is testing if a single injection of iltamiocel can help women with chronic fecal incontinence due to childbirth injuries feel better by reducing their symptoms.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment200 (estimated)
Ages18 Years and up
SexFemale
SponsorCook MyoSite Industry-sponsored
Locations26 sites (La Jolla, California and 25 other locations)
Trial IDNCT05776277 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of a single injection of iltamiocel, a cell therapy product, compared to a placebo in reducing the frequency of fecal incontinence episodes in adult females with chronic fecal incontinence and a history of obstetric anal sphincter injury. Participants will be randomly assigned to receive either iltamiocel or a placebo, and the study will be conducted in a double-blind manner to ensure unbiased results. The study aims to assess the potential benefits of using the participant's own muscle cells to improve anal sphincter function. After the initial 12-month period, those receiving placebo will have the opportunity to receive the active treatment.

Who should consider this trial

Good fit: Ideal candidates are adult females aged 18 and older with chronic fecal incontinence for at least 12 months and a history of obstetric anal sphincter injury.

Not a fit: Patients with unstable symptoms due to implanted neuromodulation systems or those with rectal sensory dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce fecal incontinence episodes and improve quality of life for affected women.

How similar studies have performed: Other studies involving cell therapy for fecal incontinence have shown promise, but this specific approach with iltamiocel is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

La Jolla, California and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Fecal IncontinenceObstetric TraumaObstetric InjuryCell TherapyAnal IncontinenceRectal DiseasesIntestinal DiseasesGastrointestinal Diseases
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.