Autologous Muscle Derived Cells Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence

Summary

This study evaluates the efficacy and safety of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR; generic name: iltamiocel) compared to a placebo in the reduction of stress incontinence episode frequency in adult female patients with post-surgical persistent or recurrent stress urinary incontinence (SUI). Half of the participants will receive AMDC-USR (injections with cells) and the other half will receive placebo.

Timeline

Start

2019-04-23

Primary completion

2026-09

Completion

2027-09

Drugs

Indications