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Autologous Muscle Derived Cells for Female Urinary Sphincter Repair

NCT01893138 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 311

Last updated 2023-01-05

Study results available
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Summary

This randomized, double-blind, placebo-controlled, multicenter, confirmatory study will evaluate the efficacy and safety of Cook MyoSite Incorporated Autologous Muscle-Derived Cells (generic name Iltamiocel) compared to a placebo (vehicle) control dose in the treatment of stress urinary incontinence (SUI) in adult female patients.

Conditions

  • Stress Urinary Incontinence

Interventions

OTHER

Placebo

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

BIOLOGICAL

Iltamiocel

AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10\^6 cells.

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
2013-11-21
Primary Completion
2019-11-01
Completion
2020-11-10
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Germany

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 NCT01893138 on ClinicalTrials.gov