200
Participants
Start Date
March 21, 2024
Primary Completion Date
September 30, 2026
Study Completion Date
September 30, 2027
Iltamiocel
Single external anal sphincter (EAS) injection of 300 x 10\^6 cells.
Placebo
Placebo control is the vehicle solution used for the study product.
The Mount Sinai Medical Center, New York
Weill Cornell Medicine, New York
Westchester Medical Center, Hawthorne
Stony Brook University Hospital, Stony Brook
Colorectal Wellness Center, Fayetteville
University of Florida Shands Hospital, Gainesville
Orlando Health Colon & Rectal Institute, Orlando
Healthcare Clinical Data, Inc., Miami
USF Health South Tampa Center for Advanced Healthcare, Tampa
Cleveland Clinic Main Campus Crile Building, Cleveland
Franciscan Health Indianapolis, Indianapolis
Corewell Health, Grand Rapids
Bennett Institute of Urogynecology and Incontinence, Grand Rapids
University of Minnesota, Minneapolis
Mayo Clinic, Rochester
University of Illinois, Chicago
Washington University School of Medicine, St Louis
Ochsner Health, New Orleans
American Association of Female Pelvic Medicine, Westlake Village
UC San Diego Health, La Jolla
Prestige Medical Group, Tustin
UC Irvine Medical Center, Orange
University of California, San Francisco - Center for Colorectal Surgery, San Francisco
Massachusetts General Hospital, Boston
Rutgers, Robert Wood Johnson Medical School, Clinical Research Center, New Brunswick
Rhode Island Hospital, Providence
Lead Sponsor
Cook MyoSite
INDUSTRY