Japanese Bridging Study of Autologous Muscle Derived Cells Compared to Placebo for Female Urinary Sphincter Repair(JPN1)

Summary

This is a confirmatory/bridging study to evaluate the efficacy and safety of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) compared with placebo in the treatment of stress urinary incontinence (SUI) in adult Japanese female subjects. Half of the participants will receive AMDC-USR (injections with cells) and the other half will receive placebo.

Timeline

Start

2025-06

Primary completion

2026-06

Completion

2027-06

Outcome

Outcome not reported

Stopped (Enrollment): “Study not initiated due to business decision, no participants enrolled.”

Drugs

Indications