Amdc-Usr

A Double-blind, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR With Placebo in Female Subjects With Stress Urinary Incontinence

Amdc-Usr [NCT01893138]

Description: This randomized, double-blind, placebo-controlled, multicenter, confirmatory study will evaluate the efficacy and safety of Cook MyoSite Incorporated Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) compared to a placebo (vehicle) control dose in the treatment of stress urinary incontinence (SUI) in adult female patients.

 

Biological: Roll-in; Other: Placebo; Biological: AMDC for USR


Primary Investigator: Karram

Drug/Device Information
Phase 3 study comparing the Safety and Efficacy of AMDC-USR With Placebo in Female Subjects With Stress Urinary Incontinence
Phase 3 Autologous muscle derived cells (AMDC) for urinary sphincter repair
Randomized 1:1 AMDC vs placebo
Cook Myosite, Inc.