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Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury

NCT05776277 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-05-22

No results posted yet for this 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

  • Fecal Incontinence

Interventions

BIOLOGICAL

Iltamiocel

Single external anal sphincter (EAS) injection of 300 x 10\^6 cells.

OTHER

Placebo

Placebo control is the vehicle solution used for the study product.

Sponsors & Collaborators

  • Cook MyoSite

    lead INDUSTRY

Principal Investigators

  • Ron Jankowski, PhD · Cook Myosite, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-21
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05776277 on ClinicalTrials.gov