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Active, not recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT03104517

Public ClinicalTrials.gov record NCT03104517. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 8:04 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT03104517
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Cook MyoSite
Industry
Enrollment
96 participants

Conditions and interventions

Interventions

Biological · Other

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 23, 2019 (Actual)
Primary completion
Jun 11, 2026 (Actual)
Completion
Nov 2026 (Estimated)
Last update posted
Oct 21, 2026

2019 – 2026

United States locations

U.S. sites
20
U.S. states
14
U.S. cities
20
Facility City State ZIP Site status
Del Sol Research Management, LLC Tucson Arizona 85715 —
San Diego Clinical Trials La Mesa California 91942 —
UCLA Women's Health Clinical Research Unit/Department of OBGYN Los Angeles California 90095 —
Stanford Hospital and Clinics Stanford California 94305 —
American Association of Female Pelvic Medicines Research Institute Westlake Village California 91361 —
MedStar Georgetown Hospital Department of Urology Washington D.C. District of Columbia 20007 —
University of Kansas Health System Kansas City Kansas 66160 —
Bennett Institute of Urogynecology and Incontinence Grand Rapids Michigan 49456 —
University of New Mexico Women's Care Clinic Albuquerque New Mexico 87131 —
AccuMed Research Associates Garden City New York 11530 —
Northwell Health/The Arthur Smith Institute for Urology Lake Success New York 11042 —
Columbia University Irving Medical Center New York New York 10032 —
Atrium Health Charlotte North Carolina 20207 —
Cleveland Clinic/Glickman Institute-Q10 Cleveland Ohio 44195 —
Magee Women's Hospital of UPMC Pittsburgh Pennsylvania 15213 —
Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic Sioux Falls South Dakota 57105 —
Vanderbilt University Medical Center, Dept. of Urologic Surgery Nashville Tennessee 37232 —
Houston Methodist Hospital Houston Texas 77030 —
Cedar Health Research Irving Texas 75062 —
Virginia Mason Medical Center Seattle Washington 98101 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03104517, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 21, 2026 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03104517 live on ClinicalTrials.gov.

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