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

March 11, 2026 updated by: Cook MyoSite

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Phase 3

Expanded Access

Temporarily not available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 8DH
        • Derriford Hospital
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85715
        • Del Sol Research Management, LLC
    • California
      • La Mesa, California, United States, 91942
        • San Diego Clinical Trials
      • Los Angeles, California, United States, 90095
        • UCLA Women's Health Clinical Research Unit/Department of OBGYN
      • Stanford, California, United States, 94305
        • Stanford Hospital and Clinics
      • Westlake Village, California, United States, 91361
        • American Association of Female Pelvic Medicines Research Institute
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • MedStar Georgetown Hospital Department of Urology
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Health System
    • Michigan
      • Grand Rapids, Michigan, United States, 49456
        • Bennett Institute of Urogynecology and Incontinence
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico Women's Care Clinic
    • New York
      • Garden City, New York, United States, 11530
        • AccuMed Research Associates
      • Lake Success, New York, United States, 11042
        • Northwell Health/The Arthur Smith Institute for Urology
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 20207
        • Atrium Health
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic/Glickman Institute-Q10
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee Women's Hospital of UPMC
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center, Dept. of Urologic Surgery
    • Texas
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital
      • Irving, Texas, United States, 75062
        • Cedar Health Research
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AMDC-USR (iltamiocel)
Autologous muscle-derived cells for urinary sphincter repair (AMDC-USR; generic name: iltamiocel) is the study product.
Biological: AMDC-USR (iltamiocel)
Autologous Muscle Derived Cells for Urinary Sphincter Repair (generic name: iltamiocel)
Placebo Comparator: Placebo
Placebo control is the vehicle solution used for the study product.
Other: Placebo
Placebo control is the vehicle solution used for the study product.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of leaks due to stress incontinence episodes, as recorded in a diary
Time Frame: 12 months
Stress leak frequency
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook MyoSite

Investigators

  • Principal Investigator: Melissa Kaufman, M.D., Ph.D., Vanderbilt University Medical Center, Department of Urologic Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2019

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

April 3, 2017

First Submitted That Met QC Criteria

April 3, 2017

First Posted (Actual)

April 7, 2017

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stress Urinary Incontinence

Clinical Trials on AMDC-USR (iltamiocel)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe