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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01893138
Other study ID # 13-003
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 21, 2013
Est. completion date November 10, 2020

Study information

Verified date December 2022
Source Cook MyoSite
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Study comparing intrasphincteric injection of iltamiocel with placebo. Subjects unblinded after 12 month visits, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.


Recruitment information / eligibility

Status Completed
Enrollment 311
Est. completion date November 10, 2020
Est. primary completion date November 1, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Female patient has primary symptoms of SUI, as confirmed by patient medical history and clinical symptoms, including a focused incontinence evaluation. Exclusion Criteria: - Patient has symptoms of pure urge incontinence as confirmed by basic evaluation of etiology from a patient medical history, including a focused incontinence history. - Patient has symptoms of mixed urinary incontinence where urge incontinence is the predominant factor. - Patient has had stress urinary incontinence symptoms less than 6 months prior to signing the informed consent. - Patient has not previously attempted conservative treatment prior to signing the informed consent. (Examples of conservative treatment include behavior modifications, bladder exercises, biofeedback, etc.) - Patient has more than 2 episode of awakening to void during normal sleeping hours. - Patient cannot be maintained on a stable dose and/or frequency of medication (including diuretics) known to affect lower urinary tract function, including but not limited to, anticholinergics, tricyclic antidepressants or alpha-adrenergic blockers, for at least 2 weeks prior to screening or is likely to change during the course of the study. - Patient is pregnant, lactating, or plans to become pregnant during the course of the study. - Patient refuses to provide written informed consent. - Patient is not at least 18 years of age. - Patient is not available for the follow-up evaluations as required by the protocol.

Study Design


Intervention

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.

Locations

Country Name City State
Belgium University Hospital Leuven Leuven
Germany Universitätsklinikum Essen Essen
Germany Praxisklinik Urologie Rhein-Ruhr (PUR/R) Mülheim
United States The American Association of Female Pelvic Medicine Specialists Agoura Hills California
United States Emory University Atlanta Georgia
United States Montefiore Medical Center Bronx New York
United States Medical University of South Carolina Charleston South Carolina
United States McKay Urology Charlotte North Carolina
United States The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital Cincinnati Ohio
United States Cleveland Clinic Cleveland Ohio
United States Inova Fairfax Hospital Falls Church Virginia
United States Female Pelvic Medicine & Urogynecology Institute of Michigan Grand Rapids Michigan
United States Mercy Health Saint Mary's Campus Grand Rapids Michigan
United States Greenville Health System Greenville South Carolina
United States Methodist Urology Associates Houston Texas
United States IU Health Physicians Urogynecology Indianapolis Indiana
United States Ronald Reagan UCLA Medical Center Los Angeles California
United States Vanderbilt University Medical Center Nashville Tennessee
United States NYU Urology Associates New York New York
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Mayo Clinic Arizona Phoenix Campus Phoenix Arizona
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States Premier Medical Group of the Hudson Valley PC Poughkeepsie New York
United States William Beaumont Hospital Royal Oak Michigan
United States Benaroya Research Institute at Virginia Mason Seattle Washington
United States Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic Sioux Falls South Dakota
United States NorthShore University HealthSystem Skokie Illinois
United States Stanford University Stanford California
United States Cleveland Clinic Florida Weston Florida

Sponsors (1)

Lead Sponsor Collaborator
Cook MyoSite

Countries where clinical trial is conducted

United States,  Belgium,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other Association of Change in Quality of Life Scores With Change in Stress Incontinence Episode Frequency Spearman's correlation used for analysis Baseline and 12 months
Other Treatment Durability at 24 Months Treatment durability defined as iltamiocel-treated participants with reduction in stress incontinence episode frequency (SIEF) at 12 months who maintained that response at 24 months Baseline, 12 months, and 24 months after injection with iltamiocel
Primary Participants With = 50% Reduction in Stress Incontinence Episode Frequency From Baseline to 12 Months Post-treatment; as Assessed by 3 Day Diary Baseline and 12 months
Secondary Participants With at = 75% Reduction in Stress Incontinence Episodes From Baseline at 12 Months Baseline and 12 months
Secondary Participants With 0 or 1 Stress Incontinence Episodes Based on 3 Day Diary Records at 12 Months Baseline and 12 months
Secondary Change in the Frequency of Stress Incontinence Episodes From Baseline at 12 Months Baseline and 12 months
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