CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 311 enrolled
Drug / intervention
Iltamiocel +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01893138
NCT01893138Phase 3Completed
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A Double-blind, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR With Placebo in Female Subjects With Stress Urinary Incontinence

Cook MyoSite·interventional·Posted Jul 8, 2013·Updated Jan 5, 2023

In Brief

A Phase 3 clinical trial evaluating Placebo and Iltamiocel for Stress Urinary Incontinence. Completed, enrolled 311 participants across 29 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStress Urinary Incontinence
CountriesBelgium, Germany, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 8, 2013
Enrollment StartNov 21, 2013
Primary CompletionNov 1, 2019
Study CompletionNov 10, 2020
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 13.0 years ago

Interventions

Placeboother

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

Iltamiocelbiological

AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10\^6 cells.