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Cell therapy aims to fix stubborn bladder leaks after failed surgery

NCT ID NCT03104517

Disease control Sponsor: Cook MyoSite Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new treatment called AMDC-USR (iltamiocel) for women who still have stress urinary incontinence after having surgery for it. The treatment uses the patient's own muscle cells injected into the urinary sphincter to strengthen it. Half of the 96 participants get the cell injection, half get a placebo, and researchers track how many leaking episodes they have.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 96 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2019

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

female stress incontinence Lower Urinary Tract Symptoms nocturnal enuresis Urinary Incontinence Urinary Incontinence, Stress urinary system disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Stress urinary incontinence

Contacts and locations

Locations

  • AccuMed Research Associates

    Garden City, New York, 11530, United States

  • American Association of Female Pelvic Medicines Research Institute

    Westlake Village, California, 91361, United States

  • Atrium Health

    Charlotte, North Carolina, 20207, United States

  • Bennett Institute of Urogynecology and Incontinence

    Grand Rapids, Michigan, 49456, United States

  • Cedar Health Research

    Irving, Texas, 75062, United States

  • Cleveland Clinic/Glickman Institute-Q10

    Cleveland, Ohio, 44195, United States

  • Columbia University Irving Medical Center

    New York, New York, 10032, United States

  • Del Sol Research Management, LLC

    Tucson, Arizona, 85715, United States

  • Derriford Hospital

    Plymouth, Devon, PL6 8DH, United Kingdom

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Magee Women's Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213, United States

  • MedStar Georgetown Hospital Department of Urology

    Washington D.C., District of Columbia, 20007, United States

  • Northwell Health/The Arthur Smith Institute for Urology

    Lake Success, New York, 11042, United States

  • San Diego Clinical Trials

    La Mesa, California, 91942, United States

  • Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic

    Sioux Falls, South Dakota, 57105, United States

  • Stanford Hospital and Clinics

    Stanford, California, 94305, United States

  • UCLA Women's Health Clinical Research Unit/Department of OBGYN

    Los Angeles, California, 90095, United States

  • University of Kansas Health System

    Kansas City, Kansas, 66160, United States

  • University of New Mexico Women's Care Clinic

    Albuquerque, New Mexico, 87131, United States

  • Vanderbilt University Medical Center, Dept. of Urologic Surgery

    Nashville, Tennessee, 37232, United States

  • Virginia Mason Medical Center

    Seattle, Washington, 98101, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.