Autologous Muscle Derived Cells for Female Urinary Sphincter Repair

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01893138
Study type	Interventional
Source	Cook MyoSite
Contact
Status	Completed
Phase	Phase 3
Start date	November 21, 2013
Completion date	November 10, 2020

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