This randomized, double-blind, placebo-controlled, multicenter, confirmatory study will evaluate the efficacy and safety of Cook MyoSite Incorporated Autologous Muscle-Derived Cells (generic name Iltamiocel) compared to a placebo (vehicle) control dose in the treatment of stress urinary incontinence (SUI) in adult female patients.
Study comparing intrasphincteric injection of iltamiocel with placebo. Subjects unblinded after 12 month visits, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
311
Placebo control is the vehicle solution used for the study product.
AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10\^6 cells.
Participants With ≥ 50% Reduction in Stress Incontinence Episode Frequency From Baseline to 12 Months Post-treatment; as Assessed by 3 Day Diary
Time frame: Baseline and 12 months
Participants With at ≥ 75% Reduction in Stress Incontinence Episodes From Baseline at 12 Months
Time frame: Baseline and 12 months
Participants With 0 or 1 Stress Incontinence Episodes Based on 3 Day Diary Records at 12 Months
Time frame: Baseline and 12 months
Change in the Frequency of Stress Incontinence Episodes From Baseline at 12 Months
Time frame: Baseline and 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Mayo Clinic Arizona Phoenix Campus
Phoenix, Arizona, United States
The American Association of Female Pelvic Medicine Specialists
Agoura Hills, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
Stanford University
Stanford, California, United States
Cleveland Clinic Florida
Weston, Florida, United States
Emory University
Atlanta, Georgia, United States
NorthShore University HealthSystem
Skokie, Illinois, United States
IU Health Physicians Urogynecology
Indianapolis, Indiana, United States
Female Pelvic Medicine & Urogynecology Institute of Michigan
Grand Rapids, Michigan, United States
Mercy Health Saint Mary's Campus
Grand Rapids, Michigan, United States
...and 19 more locations