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

NCT03104517 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-03-13

No results posted yet for this study

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.

Conditions

  • Stress Urinary Incontinence

Interventions

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.

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
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-23
Primary Completion
2026-09-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States
  • United Kingdom

Study Locations

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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 NCT03104517 on ClinicalTrials.gov