311
Participants
Start Date
November 21, 2013
Primary Completion Date
November 1, 2019
Study Completion Date
November 10, 2020
Placebo
Placebo control is the vehicle solution used for the study product.
Iltamiocel
AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10\^6 cells.
University Hospital Leuven, Leuven
NYU Urology Associates, New York
Montefiore Medical Center, The Bronx
Premier Medical Group of the Hudson Valley PC, Poughkeepsie
University of Pittsburgh Medical Center, Pittsburgh
Inova Fairfax Hospital, Falls Church
McKay Urology, Charlotte
Medical University of South Carolina, Charleston
Greenville Health System, Greenville
Emory University, Atlanta
Cleveland Clinic Florida, Weston
Vanderbilt University Medical Center, Nashville
Cleveland Clinic, Cleveland
Universitätsklinikum Essen, Essen
The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital, Cincinnati
Praxisklinik Urologie Rhein-Ruhr (PUR/R), Mülheim
IU Health Physicians Urogynecology, Indianapolis
William Beaumont Hospital, Royal Oak
Female Pelvic Medicine & Urogynecology Institute of Michigan, Grand Rapids
Mercy Health Saint Mary's Campus, Grand Rapids
Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic, Sioux Falls
NorthShore University HealthSystem, Skokie
University of Oklahoma Health Sciences Center, Oklahoma City
Methodist Urology Associates, Houston
Mayo Clinic Arizona Phoenix Campus, Phoenix
Ronald Reagan UCLA Medical Center, Los Angeles
The American Association of Female Pelvic Medicine Specialists, Agoura Hills
Stanford University, Stanford
Benaroya Research Institute at Virginia Mason, Seattle
Lead Sponsor
Cook MyoSite
INDUSTRY