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Trial record 1 of 1 for:    NCT03104517
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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 : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Cook MyoSite

Tracking Information
First Submitted Date  ICMJE April 3, 2017
First Posted Date  ICMJE April 7, 2017
Last Update Posted Date May 16, 2019
Actual Study Start Date  ICMJE April 23, 2019
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2017)
Number of leaks due to stress incontinence episodes, as recorded in a diary [ Time Frame: 12 months ]
Stress leak frequency
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03104517 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adaptive Design Study of Autologous Muscle Derived Cells Compared to Placebo for Female Urinary Sphincter Repair
Official Title  ICMJE 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
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.
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stress Urinary Incontinence
Intervention  ICMJE
  • Biological: AMDC-USR
    Autologous Muscle Derived Cells for Urinary Sphincter Repair
  • Other: Placebo
    Placebo control is the vehicle solution used for the study product.
Study Arms  ICMJE
  • Experimental: AMDC-USR
    AMDC-USR is the study product (autologous muscle derived cells for urinary sphincter repair).
    Intervention: Biological: AMDC-USR
  • Placebo Comparator: Placebo
    Placebo control is the vehicle solution used for the study product.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 23, 2018)
320
Original Estimated Enrollment  ICMJE
 (submitted: April 3, 2017)
156
Estimated Study Completion Date  ICMJE September 2023
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Christina Benjes 866-267-4479 Christina.Benjes@Quintiles.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03104517
Other Study ID Numbers  ICMJE 15-06
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cook MyoSite
Study Sponsor  ICMJE Cook MyoSite
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Melissa Kaufman, M.D., Ph.D. Vanderbilt University Medical Center, Department of Urologic Surgery
PRS Account Cook MyoSite
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP