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Adaptive Design Study of Autologous Muscle Derived Cells Compared to Placebo for Female Urinary Sphincter Repair (CELLEBRATE)

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ClinicalTrials.gov Identifier: NCT03104517
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
Cook MyoSite

Brief Summary:
This study evaluates the efficacy and safety of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) compared to a placebo in the treatment of stress urinary incontinence (SUI) in adult female patients. Half of the participants will receive AMDC-USR (injections with cells) and the other half will receive placebo.

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Biological: AMDC-USR Other: Placebo Phase 3

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) 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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CELLEBRATE: An Adaptive, Two-Stage, Double-Blind, Stratified, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR With Placebo in Female Subjects With Stress Urinary Incontinence
Actual Study Start Date : April 23, 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AMDC-USR
AMDC-USR is the study product (autologous muscle derived cells for urinary sphincter repair).
Biological: AMDC-USR
Autologous Muscle Derived Cells for Urinary Sphincter Repair

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.




Primary Outcome Measures :
  1. Number of leaks due to stress incontinence episodes, as recorded in a diary [ Time Frame: 12 months ]
    Stress leak frequency



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult female patient 50 to 75 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03104517


Contacts
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Contact: Christina Benjes 866-267-4479 Christina.Benjes@IQVIA.com

Locations
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United States, District of Columbia
MedStar Georgetown Hospital Department of Urology Recruiting
Washington, District of Columbia, United States, 20007
Principal Investigator: Elizabeth Timbrook Brown         
United States, Michigan
Beaumont Hospital, Royal Oak Recruiting
Royal Oak, Michigan, United States, 48073
Principal Investigator: Larry Sirls         
United States, New Mexico
University of New Mexico Clinical & Translational Science Center Recruiting
Albuquerque, New Mexico, United States, 87131
Principal Investigator: Yuko Margaret Komesu         
United States, Ohio
Cleveland Clinic/Glickman Institute-Q10 Recruiting
Cleveland, Ohio, United States, 44195
Principal Investigator: Howard Goldman         
United States, Oklahoma
University of Oklahoma Physicians Building Recruiting
Oklahoma City, Oklahoma, United States, 73104
Principal Investigator: Lieschen Quiroz         
United States, South Dakota
Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic Recruiting
Sioux Falls, South Dakota, United States, 57105
Principal Investigator: Kevin Benson         
United States, Tennessee
Vanderbilt University Medical Center, Dept. of Urologic Surgery Recruiting
Nashville, Tennessee, United States, 37232
Principal Investigator: Roger Dmochowski         
United States, Texas
Urology Clinics of North Texas, PLLC Recruiting
Dallas, Texas, United States, 75231
Principal Investigator: Brian Feagins         
Scott and White Medical Center - Temple Recruiting
Temple, Texas, United States, 76508
Principal Investigator: Jill Danford         
United States, Virginia
Urology of Virginia, PLLC Recruiting
Virginia Beach, Virginia, United States, 23462
Principal Investigator: Kurt McCammon         
United States, Washington
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
Principal Investigator: Una Lee         
United States, Wisconsin
Aurora Medical Center, West Allis Recruiting
Milwaukee, Wisconsin, United States, 53227
Principal Investigator: Alexis Chesrow         
Sponsors and Collaborators
Cook MyoSite
Investigators
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Principal Investigator: Melissa Kaufman, M.D., Ph.D. Vanderbilt University Medical Center, Department of Urologic Surgery

Additional Information:
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Responsible Party: Cook MyoSite
ClinicalTrials.gov Identifier: NCT03104517     History of Changes
Other Study ID Numbers: 15-06
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cook MyoSite:
Lower Urinary Tract Symptoms
Urinary Incontinence
Urinary Stress Incontinence
Urinary Bladder
Urinary Tract Diseases
Bladder
Urinary Leak
Urine Leak
Bladder Leak
Urethra
Urethral Sphincter

Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders