Autologous Muscle Derived Cells Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

April 23, 2019

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2027

Conditions
Stress Urinary Incontinence
Interventions
BIOLOGICAL

AMDC-USR (iltamiocel)

Autologous Muscle Derived Cells for Urinary Sphincter Repair (generic name: iltamiocel)

OTHER

Placebo

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

Trial Locations (21)

10032

Columbia University Irving Medical Center, New York

11042

Northwell Health/The Arthur Smith Institute for Urology, Lake Success

11530

AccuMed Research Associates, Garden City

15213

Magee Women's Hospital of UPMC, Pittsburgh

20007

MedStar Georgetown Hospital Department of Urology, Washington D.C.

20207

Atrium Health, Charlotte

37232

Vanderbilt University Medical Center, Dept. of Urologic Surgery, Nashville

44195

Cleveland Clinic/Glickman Institute-Q10, Cleveland

49456

Bennett Institute of Urogynecology and Incontinence, Grand Rapids

57105

Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic, Sioux Falls

66160

University of Kansas Health System, Kansas City

75062

Cedar Health Research, Irving

77030

Houston Methodist Hospital, Houston

85715

Arizona Urology Specialists, Tucson

87131

University of New Mexico Women's Care Clinic, Albuquerque

90095

UCLA Women's Health Clinical Research Unit/Department of OBGYN, Los Angeles

91361

American Association of Female Pelvic Medicines Research Institute, Westlake Village

91942

San Diego Clinical Trials, La Mesa

94305

Stanford Hospital and Clinics, Stanford

98101

Virginia Mason Medical Center, Seattle

PL6 8DH

Derriford Hospital, Plymouth

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Cook MyoSite

INDUSTRY