Autologous Muscle Derived Cells Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence

NCT03104517 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 15-06
• Study Type: interventional
• Target: 96
• Locations: 2 countries
• Sites: 21

Brief Summary

This study evaluates the efficacy and safety of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR; generic name: iltamiocel) compared to a placebo in the reduction of stress incontinence episode frequency in adult female patients with post-surgical persistent or recurrent stress urinary incontinence (SUI). Half of the participants will receive AMDC-USR (injections with cells) and the other half will receive placebo.

Conditions

Stress Urinary Incontinence

Keywords

Urinary Incontinence; Urinary Stress Incontinence; Lower Urinary Tract Symptoms; Urinary Bladder; Urinary Tract Diseases; Bladder; Urinary Leak; Urine Leak; Bladder Leak; Urethra; Urethral Sphincter; Persistent Incontinence; Recurrent Incontinence; Incontinence Surgery; Sling Surgery; Stress Urinary Incontinence Surgery

Outcome Measures

Primary Outcomes (1)

• Number of leaks due to stress incontinence episodes, as recorded in a diary

  Stress leak frequency

  12 months

Study Arms (2)

AMDC-USR (iltamiocel)

EXPERIMENTAL

Autologous muscle-derived cells for urinary sphincter repair (AMDC-USR; generic name: iltamiocel) is the study product.

Biological: AMDC-USR (iltamiocel)

Placebo

PLACEBO COMPARATOR

Placebo control is the vehicle solution used for the study product.

Other: Placebo

Interventions

AMDC-USR (iltamiocel) BIOLOGICAL

Autologous Muscle Derived Cells for Urinary Sphincter Repair (generic name: iltamiocel)

AMDC-USR (iltamiocel)

Placebo OTHER

Placebo control is the vehicle solution used for the study product.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cook MyoSite: lead

Study Sites (21)

Del Sol Research Management, LLC

Tucson, Arizona, 85715, United States

Location

San Diego Clinical Trials

La Mesa, California, 91942, United States

Location

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

Los Angeles, California, 90095, United States

Location

Stanford Hospital and Clinics

Stanford, California, 94305, United States

Location

American Association of Female Pelvic Medicines Research Institute

Westlake Village, California, 91361, United States

Location

MedStar Georgetown Hospital Department of Urology

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

Location

University of Kansas Health System

Kansas City, Kansas, 66160, United States

Location

Bennett Institute of Urogynecology and Incontinence

Grand Rapids, Michigan, 49456, United States

Location

University of New Mexico Women's Care Clinic

Albuquerque, New Mexico, 87131, United States

Location

AccuMed Research Associates

Garden City, New York, 11530, United States

Location

Northwell Health/The Arthur Smith Institute for Urology

Lake Success, New York, 11042, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Atrium Health

Charlotte, North Carolina, 20207, United States

Location

Cleveland Clinic/Glickman Institute-Q10

Cleveland, Ohio, 44195, United States

Location

Magee Women's Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic

Sioux Falls, South Dakota, 57105, United States

Location

Vanderbilt University Medical Center, Dept. of Urologic Surgery

Nashville, Tennessee, 37232, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Cedar Health Research

Irving, Texas, 75062, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Derriford Hospital

Plymouth, Devon, PL6 8DH, United Kingdom

Location

Related Links

• https://www.suiclinicalstudy.com/

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence; Lower Urinary Tract Symptoms; Urologic Diseases; Nocturnal Enuresis

Condition Hierarchy (Ancestors)

Urination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Enuresis; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Officials

• Melissa Kaufman, M.D., Ph.D.

  Vanderbilt University Medical Center, Department of Urologic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: April 7, 2017
• Study Start: April 23, 2019
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (20); GB (1)