Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury
Public ClinicalTrials.gov record NCT05776277. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT05776277
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 200 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 21, 2024 (Actual)
- Primary completion
- Dec 2026 (Estimated)
- Completion
- Dec 2027 (Estimated)
- Last update posted
- Oct 20, 2026
2024 – 2027
United States locations
- U.S. sites
- 25
- U.S. states
- 14
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UC San Diego Health | La Jolla | California | 92122 | — |
| UC Irvine Medical Center | Orange | California | 92868 | — |
| University of California, San Francisco - Center for Colorectal Surgery | San Francisco | California | 94158 | — |
| Prestige Medical Group | Tustin | California | 92780 | — |
| American Association of Female Pelvic Medicine | Westlake Village | California | 91361 | — |
| University of Florida Shands Hospital | Gainesville | Florida | 32610 | — |
| Healthcare Clinical Data, Inc. | Miami | Florida | 33161 | — |
| Orlando Health Colon & Rectal Institute | Orlando | Florida | 32806 | — |
| USF Health South Tampa Center for Advanced Healthcare | Tampa | Florida | 33606 | — |
| Colorectal Wellness Center | Fayetteville | Georgia | 30214 | — |
| University of Illinois | Chicago | Illinois | 60612 | — |
| Franciscan Health Indianapolis | Indianapolis | Indiana | 46237 | — |
| Ochsner Health | New Orleans | Louisiana | 70121 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Bennett Institute of Urogynecology and Incontinence | Grand Rapids | Michigan | 49546 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Rutgers, Robert Wood Johnson Medical School, Clinical Research Center | New Brunswick | New Jersey | 08901 | — |
| Westchester Medical Center | Hawthorne | New York | 10532 | — |
| The Mount Sinai Medical Center | New York | New York | 10029 | — |
| Weill Cornell Medicine | New York | New York | 10065 | — |
| Stony Brook University Hospital | Stony Brook | New York | 11794 | — |
| Cleveland Clinic Main Campus Crile Building | Cleveland | Ohio | 44195 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05776277, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 20, 2026 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05776277 live on ClinicalTrials.gov.