Autologous Muscle Derived Cells for Female Urinary Sphincter Repair

A Double-blind, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR With Placebo in Female Subjects With Stress Urinary Incontinence

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.

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Other: Placebo; Biological: Iltamiocel

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 311
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • University Hospital Leuven
• Germany
  • Essen, Germany, 45147
    • Universitätsklinikum Essen
  • Mülheim, Germany, 45468
    • Praxisklinik Urologie Rhein-Ruhr (PUR/R)
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Arizona Phoenix Campus
  • California
    • Agoura Hills, California, United States, 91301
      • The American Association of Female Pelvic Medicine Specialists
    • Los Angeles, California, United States, 90024
      • Ronald Reagan UCLA Medical Center
    • Stanford, California, United States, 94304
      • Stanford University
  • Florida
    • Weston, Florida, United States, 33331
      • Cleveland Clinic Florida
  • Georgia
    • Atlanta, Georgia, United States, 30033
      • Emory University
  • Illinois
    • Skokie, Illinois, United States, 60076
      • NorthShore University HealthSystem
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • IU Health Physicians Urogynecology
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Female Pelvic Medicine & Urogynecology Institute of Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Mercy Health Saint Mary's Campus
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • New York, New York, United States, 10016
      • NYU Urology Associates
    • Poughkeepsie, New York, United States, 12601
      • Premier Medical Group of the Hudson Valley PC
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • McKay Urology
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Greenville, South Carolina, United States, 29607
      • Greenville Health System
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • Methodist Urology Associates
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital
  • Washington
    • Seattle, Washington, United States, 98101
      • Benaroya Research Institute at Virginia Mason

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo control is the vehicle solution used for the study product.	Other: Placebo; Placebo control is the vehicle solution used for the study product.
Experimental: Iltamiocel; AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10^6 cells.	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.; Other Names: Autologous muscle-derived cells (AMDC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Participants With at ≥ 75% Reduction in Stress Incontinence Episodes From Baseline at 12 Months	Baseline and 12 months
Participants With 0 or 1 Stress Incontinence Episodes Based on 3 Day Diary Records at 12 Months	Baseline and 12 months
Change in the Frequency of Stress Incontinence Episodes From Baseline at 12 Months	Baseline and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Cook MyoSite

Publications and helpful links

General Publications

• Antosh DD, High R, Brown HW, Oliphant SS, Abed H, Philip N, Grimes CL. Feasibility of prophylactic salpingectomy during vaginal hysterectomy. Am J Obstet Gynecol. 2017 Nov;217(5):605.e1-605.e5. doi: 10.1016/j.ajog.2017.07.017. Epub 2017 Jul 20.

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2013
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): November 10, 2020

Study Registration Dates

• First Submitted: July 2, 2013
• First Submitted That Met QC Criteria: July 5, 2013
• First Posted (Estimate): July 8, 2013

Study Record Updates

• Last Update Posted (Actual): January 5, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Urinary Incontinence, Stress; Transplantation, Autologous; Tissue Therapy (Cell Therapy)
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: 13-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No