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

Stress Urinary Incontinence Clinical Trial

— CELLEBRATE  

Official title:

CELLEBRATE: A Double-Blind, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR With Placebo in Female Subjects With Persistent or Recurrent Stress Urinary Incontinence Following Surgical Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03104517
• Other study ID #: 15-06
• Status: Recruiting
• Phase: Phase 3
• Start date: April 23, 2019
• Est. completion date: February 2026

Study information

• Verified date: May 2024
• Source: Cook MyoSite
• Contact: Maria Jose Godino
• Phone: +54 911 3913 0952
• Email: MariaJose.Godino[@]IQVIA.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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; generic name: iltamiocel) 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: February 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Biological:
• AMDC-USR (iltamiocel)
Autologous Muscle Derived Cells for Urinary Sphincter Repair (generic name: iltamiocel)

Other:
• Placebo
Placebo control is the vehicle solution used for the study product.

Locations

Country	Name	City	State
United Kingdom	St. James's University Hospital	Leeds	Yorkshire
United Kingdom	Derriford Hospital	Plymouth	Devon
United States	University of New Mexico Women's Care Clinic	Albuquerque	New Mexico
United States	The Institute for Female Pelvic Medicine and Reconstructive Surgery	Allentown	Pennsylvania
United States	University of Colorado Hospital	Aurora	Colorado
United States	Atrium Health	Charlotte	North Carolina
United States	Cleveland Clinic/Glickman Institute-Q10	Cleveland	Ohio
United States	Urology Clinics of North Texas, PLLC	Dallas	Texas
United States	UT Southwestern Medical Center	Dallas	Texas
United States	AccuMed Research Associates	Garden City	New York
United States	Bennett Institute of Urogynecology and Incontinence	Grand Rapids	Michigan
United States	Prisma Health, Upstate	Greenville	South Carolina
United States	Houston Methodist Hospital	Houston	Texas
United States	Cedar Health Research	Irving	Texas
United States	University of Kansas Health System	Kansas City	Kansas
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	Loyola University Medical Center	Maywood	Illinois
United States	Aurora Medical Center, West Allis	Milwaukee	Wisconsin
United States	Vanderbilt University Medical Center, Dept. of Urologic Surgery	Nashville	Tennessee
United States	Columbia University Irving Medical Center	New York	New York
United States	University of Oklahoma Physicians Building	Oklahoma City	Oklahoma
United States	Magee Women's Hospital of UPMC	Pittsburgh	Pennsylvania
United States	Beaumont Hospital, Royal Oak	Royal Oak	Michigan
United States	University of California, Davis	Sacramento	California
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Louisiana State University Health Sciences Center, Shreveport	Shreveport	Louisiana
United States	Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic	Sioux Falls	South Dakota
United States	Stanford Hospital and Clinics	Stanford	California
United States	Baylor Scott and White Medical Center, Temple	Temple	Texas
United States	Arizona Urology Specialists	Tucson	Arizona
United States	Urology of Virginia, PLLC	Virginia Beach	Virginia
United States	MedStar Georgetown Hospital Department of Urology	Washington	District of Columbia
United States	Bay State Clinical Trials, Inc.	Watertown	Massachusetts
United States	American Association of Female Pelvic Medicines Research Institute	Westlake Village	California

Sponsors (1)

Lead Sponsor	Collaborator
Cook MyoSite

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of leaks due to stress incontinence episodes, as recorded in a diary	Stress leak frequency	12 months

External Links

•   https://www.suiclinicalstudy.com/