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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 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.

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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

Fecal Incontinence

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

FieldValue
Enrollment Target 200 participants
Start Date 2024-03-21
Est. Completion 2027-12
Phase Phase 3

Sponsor

Cook MyoSite

5 total trials

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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, categorized as Phase 3. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 326-participant average among 22 other Fecal Incontinence trials with a reported enrollment target (39% lower). The listed sponsor is Cook MyoSite, which has 5 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.