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

February 8, 2024 updated by: Cook MyoSite

CELLEBRATE: A Double-Blind, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR With Placebo in Female Subjects With Persistent or Recurrent Stress Urinary Incontinence Following Surgical Treatment

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Stress urinary incontinence (SUI) is the accidental loss of urine due to physical activity, such as laughing, coughing, or sneezing. Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR; generic name: iltamiocel) involves a medical procedure in which a participant's own muscle cells are collected, processed, and then injected into the tissues of the urinary passage.

This is a double-blind randomized study, which means neither the participant, nor the study doctor will know which treatment group the participant will be in. Participants who are randomly chosen to receive injection with placebo will have the option to receive an injection with their cells after completion of the blinded portion of their study participation (12 months).

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 8DH
        • Recruiting
        • Derriford Hospital
        • Principal Investigator:
          • Anupreet Dua, MD
    • Yorkshire
      • Leeds, Yorkshire, United Kingdom, LS9 7TF
        • Recruiting
        • St. James's University Hospital
        • Principal Investigator:
          • Neil Harris, MD
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85715
        • Recruiting
        • Arizona Urology Specialists
        • Principal Investigator:
          • Susan Jones Kalota, MD
    • California
      • La Mesa, California, United States, 91942
        • Recruiting
        • San Diego Clinical Trials
        • Principal Investigator:
          • Mohamed Bidair, MD
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA Women's Health Clinical Research Unit/Department of OBGYN
        • Principal Investigator:
          • Christopher Tarnay, MD
      • Sacramento, California, United States, 95817
        • Withdrawn
        • University of California, Davis
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford Hospital and Clinics
        • Principal Investigator:
          • Eric R Sokol, MD
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Withdrawn
        • University of Colorado Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Active, not recruiting
        • MedStar Georgetown Hospital Department of Urology
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Withdrawn
        • Loyola University Medical Center
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Health System
        • Principal Investigator:
          • Casey Kowalik, MD
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Withdrawn
        • Louisiana State University Health Sciences Center, Shreveport
    • Massachusetts
      • Watertown, Massachusetts, United States, 02472
        • Withdrawn
        • Bay State Clinical Trials, Inc.
    • Michigan
      • Grand Rapids, Michigan, United States, 49456
        • Recruiting
        • Bennett Institute of Urogynecology and Incontinence
        • Contact:
          • Jason Bennett, MD
      • Royal Oak, Michigan, United States, 48073
        • Withdrawn
        • Beaumont Hospital, Royal Oak
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Completed
        • University of New Mexico Women's Care Clinic
    • New York
      • Garden City, New York, United States, 11530
        • Recruiting
        • AccuMed Research Associates
        • Principal Investigator:
          • Mitchell D Efros, MD
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center
        • Principal Investigator:
          • Doreen E Chung, MD
    • North Carolina
      • Charlotte, North Carolina, United States, 20207
        • Recruiting
        • McKay Urology
        • Principal Investigator:
          • Michael Kennelly, MD
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic/Glickman Institute-Q10
        • Principal Investigator:
          • Howard Goldman, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Withdrawn
        • University of Oklahoma Physicians Building
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Withdrawn
        • The Institute for Female Pelvic Medicine and Reconstructive Surgery
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • Magee Women's Hospital of UPMC
        • Principal Investigator:
          • Christopher Chermansky, MD
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Withdrawn
        • Prisma Health, Upstate
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic
        • Principal Investigator:
          • Kevin Benson, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center, Dept. of Urologic Surgery
        • Principal Investigator:
          • Roger Dmochowski, MD
    • Texas
      • Dallas, Texas, United States, 75390
        • Withdrawn
        • UT Southwestern Medical Center
      • Dallas, Texas, United States, 75231
        • Withdrawn
        • Urology Clinics of North Texas, PLLC
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Hospital
        • Principal Investigator:
          • Danielle Antosh, MD
      • Irving, Texas, United States, 75062
        • Recruiting
        • Cedar Health Research
        • Principal Investigator:
          • Jeff M Livingston, MD
      • Temple, Texas, United States, 76508
        • Withdrawn
        • Baylor Scott and White Medical Center, Temple
    • Virginia
      • Virginia Beach, Virginia, United States, 23462
        • Withdrawn
        • Urology of Virginia, PLLC
    • Washington
      • Seattle, Washington, United States, 98101
        • Recruiting
        • Virginia Mason Medical Center
        • Principal Investigator:
          • Una Lee, MD
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53227
        • Withdrawn
        • Aurora Medical Center, West Allis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult female patient ≥ 18 years of age who has primary and moderate-to-severe symptoms of SUI for at least 6 months, as confirmed by patient medical history and clinical symptoms, including a focused incontinence evaluation.
  • History of previous surgery for treatment of SUI. Previous surgery could include midurethral sling, retropubic suspension, or bladder neck sling. Bulking agents alone are not considered previous surgery for treatment of SUI.
  • Must be willing and able to comply with the study procedures, be mentally competent and able to understand all study requirements, and must agree to read and sign the informed consent form prior to any study-related procedures.
  • Must have completed 100% of the screening 3-day diary evening reports.

Exclusion Criteria:

  • Patient has symptoms of only 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, pelvic floor muscle therapy, etc.)
  • Patient BMI ≥ 35.
  • Patient routinely has more than 2 episodes of awakening to void during normal sleeping hours.
  • If taking a medication known to affect lower urinary tract function, including but not limited to, anticholinergics, beta 3 adrenergic receptor agonists, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitor (SNRI) or selective serotonin reuptake inhibitor (SSRI) antidepressants, diuretics, or alpha-adrenergic blockers, patient cannot be maintained on a stable dose and/or frequency of medication (including diuretics), cannot be maintained on a stable dose and/or frequency for at least 2 weeks prior to screening or is likely to change during the course of the study.
  • History of cancer in pelvic organs, ureters, or kidneys.
  • Patient is pregnant, lactating, or plans to become pregnant during the course of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AMDC-USR (iltamiocel)
Autologous muscle-derived cells for urinary sphincter repair (AMDC-USR; generic name: iltamiocel) is the study product.
Biological: AMDC-USR (iltamiocel)
Autologous Muscle Derived Cells for Urinary Sphincter Repair (generic name: iltamiocel)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of leaks due to stress incontinence episodes, as recorded in a diary
Time Frame: 12 months
Stress leak frequency
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook MyoSite

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2019

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

April 3, 2017

First Submitted That Met QC Criteria

April 3, 2017

First Posted (Actual)

April 7, 2017

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-06

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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