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



Status:Recruiting
Conditions:Urology, Urology
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:50 - 75
Updated:3/17/2019
Start Date:March 20, 2019
End Date:September 2023
Contact:Christina Benjes
Email:Christina.Benjes@Quintiles.com
Phone:866-267-4479

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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

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.

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).

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.
We found this trial at
6
sites
Virginia Beach, Virginia 23462
Principal Investigator: Kurt McCammon
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mi
from
Virginia Beach, VA
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Albuquerque, New Mexico 87131
Principal Investigator: Yuko Margaret Komesu
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mi
from
Albuquerque, NM
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Cleveland, Ohio 44195
Principal Investigator: Howard Goldman
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mi
from
Cleveland, OH
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Milwaukee, Wisconsin 53227
Principal Investigator: Alexis Chesrow
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mi
from
Milwaukee, WI
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Royal Oak, Michigan 48314
Principal Investigator: Larry Sirls
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mi
from
Royal Oak, MI
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Sioux Falls, South Dakota 57105
Principal Investigator: Kevin Benson
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mi
from
Sioux Falls, SD
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