Autologous Muscle Derived Cells for Female Urinary Sphincter Repair
Public ClinicalTrials.gov record NCT01893138. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double-blind, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR With Placebo in Female Subjects With Stress Urinary Incontinence
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This randomized, double-blind, placebo-controlled, multicenter, confirmatory study will evaluate the efficacy and safety of Cook MyoSite Incorporated Autologous Muscle-Derived Cells (generic name Iltamiocel) compared to a placebo (vehicle) control dose in the treatment of stress urinary incontinence (SUI) in adult female patients.
Study identification
- NCT ID
- NCT01893138
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 311 participants
Conditions and interventions
Conditions
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
- Nov 21, 2013 (Actual)
- Primary completion
- Nov 1, 2019 (Actual)
- Completion
- Nov 10, 2020 (Actual)
- Last update posted
- Jan 5, 2023
2013 – 2020
United States locations
- U.S. sites
- 26
- U.S. states
- 18
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Arizona Phoenix Campus | Phoenix | Arizona | 85054 | — |
| The American Association of Female Pelvic Medicine Specialists | Agoura Hills | California | 91301 | — |
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90024 | — |
| Stanford University | Stanford | California | 94304 | — |
| Cleveland Clinic Florida | Weston | Florida | 33331 | — |
| Emory University | Atlanta | Georgia | 30033 | — |
| NorthShore University HealthSystem | Skokie | Illinois | 60076 | — |
| IU Health Physicians Urogynecology | Indianapolis | Indiana | 46202 | — |
| Female Pelvic Medicine & Urogynecology Institute of Michigan | Grand Rapids | Michigan | 49503 | — |
| Mercy Health Saint Mary's Campus | Grand Rapids | Michigan | 49503 | — |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | — |
| NYU Urology Associates | New York | New York | 10016 | — |
| Premier Medical Group of the Hudson Valley PC | Poughkeepsie | New York | 12601 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| McKay Urology | Charlotte | North Carolina | 28207 | — |
| The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital | Cincinnati | Ohio | 45242 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Greenville Health System | Greenville | South Carolina | 29607 | — |
| Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic | Sioux Falls | South Dakota | 57105 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Methodist Urology Associates | Houston | Texas | 77030 | — |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | — |
| Benaroya Research Institute at Virginia Mason | 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 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01893138, 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 Jan 5, 2023 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01893138 live on ClinicalTrials.gov.