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NCT05776277 · ClinicalTrials.gov registry record · Phase 3
Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury
A Phase 3 study of Fecal Incontinence, sponsored by Cook MyoSite.
- Active
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
- 20
- Study locations
NCT05776277: Active Phase 3 study of Fecal Incontinence, sponsored by Cook MyoSite.
NCT05776277 is a Phase 3 study of Fecal Incontinence that is active but no longer recruiting, run by Cook MyoSite. The registered enrollment target is 200 participants, below the 326-participant average among 22 other Fecal Incontinence trials with a reported enrollment target (39% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05776277, a Phase 3 study of Fecal Incontinence, is active but no longer recruiting, sponsored by Cook MyoSite.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Iltamiocel
Study Locations (20)
California
- UC San Diego Health - La Jolla
- UC Irvine Medical Center - Orange
- University of California, San Francisco - Center for Colorectal Surgery - San Francisco
- Prestige Medical Group - Tustin
- American Association of Female Pelvic Medicine - Westlake Village
Florida
- University of Florida Shands Hospital - Gainesville
- Healthcare Clinical Data, Inc. - Miami
- Orlando Health Colon & Rectal Institute - Orlando
- USF Health South Tampa Center for Advanced Healthcare - Tampa
Minnesota
- University of Minnesota - Minneapolis
- Mayo Clinic - Rochester
Georgia
- Colorectal Wellness Center - Fayetteville
Illinois
- University of Illinois - Chicago
Indiana
- Franciscan Health Indianapolis - Indianapolis
Louisiana
- Ochsner Health - New Orleans
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2024-03-21 |
| Est. Completion | 2027-12 |
| Phase | Phase 3 |
What the registry record for NCT05776277 still lists
NCT05776277 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 326-participant average among 22 other Fecal Incontinence trials with a reported enrollment target (39% lower).
The record links to 1 condition, with Fecal Incontinence appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05776277 names 20 study sites across 12 states, led by California, Florida, Minnesota.
Frequently Asked Questions
What is clinical trial NCT05776277 about?
NCT05776277 is a clinical study titled "Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury". 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 t...
What is the current status of trial NCT05776277?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2024-03-21. Estimated completion is 2027-12.
What conditions does trial NCT05776277 study?
This clinical trial studies the following conditions: Fecal Incontinence.
What interventions are being tested in trial NCT05776277?
The interventions under investigation include: Placebo (OTHER), Iltamiocel (BIOLOGICAL).
Who is sponsoring clinical trial NCT05776277?
This trial is sponsored by Cook MyoSite, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05776277 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Fecal Incontinence
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Where NCT05776277's enrollment target sits among peer trials
200 7th of 22 higher than 16 of 22 other Fecal Incontinence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fecal Incontinence trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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