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

NCT03997318 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2024-08-27

No results posted yet for this study

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.

Conditions

  • Stress Urinary Incontinence

Interventions

BIOLOGICAL

AMDC-USR

Autologous Muscle Derived Cells for Urinary Sphincter Repair

OTHER

Placebo

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

Sponsors & Collaborators

  • Cook MyoSite

    lead INDUSTRY

Principal Investigators

  • Melissa Kaufman, M.D., Ph.D. · Vanderbilt University Medical Center, Department of Urologic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2026-06-30
Completion
2027-06-30
FDA Drug
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03997318 on ClinicalTrials.gov