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Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury
NCT05776277 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05776277
The ClinicalTrials.gov registry entry for NCT05776277 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cook MyoSite, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05776277 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05776277?
The interventions under investigation include: Placebo (OTHER), Iltamiocel (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05776277?
This trial is sponsored by Cook MyoSite, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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