Autologous Muscle Derived Cells Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence
NCT ID: NCT03104517
Last Updated: 2025-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
96 participants
INTERVENTIONAL
2019-04-23
2027-09-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AMDC-USR (iltamiocel)
Autologous muscle-derived cells for urinary sphincter repair (AMDC-USR; generic name: iltamiocel) is the study product.
AMDC-USR (iltamiocel)
Autologous Muscle Derived Cells for Urinary Sphincter Repair (generic name: iltamiocel)
Placebo
Placebo control is the vehicle solution used for the study product.
Placebo
Placebo control is the vehicle solution used for the study product.
Interventions
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AMDC-USR (iltamiocel)
Autologous Muscle Derived Cells for Urinary Sphincter Repair (generic name: iltamiocel)
Placebo
Placebo control is the vehicle solution used for the study product.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
FEMALE
No
Sponsors
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Cook MyoSite
INDUSTRY
Responsible Party
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Principal Investigators
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Melissa Kaufman, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center, Department of Urologic Surgery
Locations
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Arizona Urology Specialists
Tucson, Arizona, United States
San Diego Clinical Trials
La Mesa, California, United States
UCLA Women's Health Clinical Research Unit/Department of OBGYN
Los Angeles, California, United States
Stanford Hospital and Clinics
Stanford, California, United States
American Association of Female Pelvic Medicines Research Institute
Westlake Village, California, United States
MedStar Georgetown Hospital Department of Urology
Washington D.C., District of Columbia, United States
University of Kansas Health System
Kansas City, Kansas, United States
Bennett Institute of Urogynecology and Incontinence
Grand Rapids, Michigan, United States
University of New Mexico Women's Care Clinic
Albuquerque, New Mexico, United States
AccuMed Research Associates
Garden City, New York, United States
Northwell Health/The Arthur Smith Institute for Urology
Lake Success, New York, United States
Columbia University Irving Medical Center
New York, New York, United States
Atrium Health
Charlotte, North Carolina, United States
Cleveland Clinic/Glickman Institute-Q10
Cleveland, Ohio, United States
Magee Women's Hospital of UPMC
Pittsburgh, Pennsylvania, United States
Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic
Sioux Falls, South Dakota, United States
Vanderbilt University Medical Center, Dept. of Urologic Surgery
Nashville, Tennessee, United States
Houston Methodist Hospital
Houston, Texas, United States
Cedar Health Research
Irving, Texas, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Derriford Hospital
Plymouth, Devon, United Kingdom
Countries
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Related Links
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https://www.suiclinicalstudy.com/
Other Identifiers
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15-06
Identifier Type: -
Identifier Source: org_study_id
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