NCT01893138

Autologous Muscle Derived Cells for Female Urinary Sphincter Repair

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 311 (actual)
• Sponsor: Cook MyoSite · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
OTHER	Placebo	Placebo control is the vehicle solution used for the study product.
BIOLOGICAL	Iltamiocel	AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10\^6 cells.

Timeline

• Start date: 2013-11-21
• Primary completion: 2019-11-01
• Completion: 2020-11-10
• First posted: 2013-07-08
• Last updated: 2023-01-05
• Results posted: 2023-01-05

Locations

29 sites across 3 countries: United States, Belgium, Germany

Regulatory

• FDA-regulated drug study