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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

March 21, 2024

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2027

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.

Trial Locations (26)

10029

The Mount Sinai Medical Center, New York

10065

Weill Cornell Medicine, New York

10532

Westchester Medical Center, Hawthorne

11794

Stony Brook University Hospital, Stony Brook

30214

Colorectal Wellness Center, Fayetteville

32610

University of Florida Shands Hospital, Gainesville

32806

Orlando Health Colon & Rectal Institute, Orlando

33161

Healthcare Clinical Data, Inc., Miami

33606

USF Health South Tampa Center for Advanced Healthcare, Tampa

44195

Cleveland Clinic Main Campus Crile Building, Cleveland

46237

Franciscan Health Indianapolis, Indianapolis

49503

Corewell Health, Grand Rapids

49546

Bennett Institute of Urogynecology and Incontinence, Grand Rapids

55455

University of Minnesota, Minneapolis

55905

Mayo Clinic, Rochester

60612

University of Illinois, Chicago

63110

Washington University School of Medicine, St Louis

70121

Ochsner Health, New Orleans

91361

American Association of Female Pelvic Medicine, Westlake Village

92122

UC San Diego Health, La Jolla

92780

Prestige Medical Group, Tustin

92868

UC Irvine Medical Center, Orange

94158

University of California, San Francisco - Center for Colorectal Surgery, San Francisco

02114

Massachusetts General Hospital, Boston

08901

Rutgers, Robert Wood Johnson Medical School, Clinical Research Center, New Brunswick

02903

Rhode Island Hospital, Providence

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Cook MyoSite

INDUSTRY