NCT03104517

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

CELLEBRATE: A Double-Blind, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR With Placebo in Female Subjects With Persistent or Recurrent Stress Urinary Incontinence Following Surgical Treatment

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Cook MyoSite · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Stress urinary incontinence (SUI) is the accidental loss of urine due to physical activity, such as laughing, coughing, or sneezing. Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR; generic name: iltamiocel) involves a medical procedure in which a participant's own muscle cells are collected, processed, and then injected into the tissues of the urinary passage. This is a double-blind randomized study, which means neither the participant, nor the study doctor will know which treatment group the participant will be in. Participants who are randomly chosen to receive injection with placebo will have the option to receive an injection with their cells after completion of the blinded portion of their study participation (12 months).

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
BIOLOGICAL	AMDC-USR (iltamiocel)	Autologous Muscle Derived Cells for Urinary Sphincter Repair (generic name: iltamiocel)
OTHER	Placebo	Placebo control is the vehicle solution used for the study product.

Timeline

• Start date: 2019-04-23
• Primary completion: 2026-09-01
• Completion: 2027-09-01
• First posted: 2017-04-07
• Last updated: 2026-03-13

Locations

21 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study