Autologous Muscle Derived Cells for Female Urinary Sphincter Repair
A Double-blind, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR With Placebo in Female Subjects With Stress Urinary Incontinence
1 other identifier
interventional
311
3 countries
29
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2013
Longer than P75 for phase_3
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2013
CompletedFirst Posted
Study publicly available on registry
July 8, 2013
CompletedStudy Start
First participant enrolled
November 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 10, 2020
CompletedResults Posted
Study results publicly available
January 5, 2023
CompletedJanuary 5, 2023
December 1, 2022
5.9 years
July 2, 2013
September 12, 2022
December 12, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Participants With ≥ 50% Reduction in Stress Incontinence Episode Frequency From Baseline to 12 Months Post-treatment; as Assessed by 3 Day Diary
Baseline and 12 months
Secondary Outcomes (3)
Participants With at ≥ 75% Reduction in Stress Incontinence Episodes From Baseline at 12 Months
Baseline and 12 months
Participants With 0 or 1 Stress Incontinence Episodes Based on 3 Day Diary Records at 12 Months
Baseline and 12 months
Change in the Frequency of Stress Incontinence Episodes From Baseline at 12 Months
Baseline and 12 months
Other Outcomes (2)
Association of Change in Quality of Life Scores With Change in Stress Incontinence Episode Frequency
Baseline and 12 months
Treatment Durability at 24 Months
Baseline, 12 months, and 24 months after injection with iltamiocel
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo control is the vehicle solution used for the study product.
Iltamiocel
EXPERIMENTALAMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10\^6 cells.
Interventions
AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10\^6 cells.
Eligibility Criteria
You may qualify if:
- Female patient has primary symptoms of SUI, as confirmed by patient medical history and clinical symptoms, including a focused incontinence evaluation.
You may not qualify if:
- Patient has symptoms of pure 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, etc.)
- Patient has more than 2 episode of awakening to void during normal sleeping hours.
- Patient cannot be maintained on a stable dose and/or frequency of medication (including diuretics) known to affect lower urinary tract function, including but not limited to, anticholinergics, tricyclic antidepressants or alpha-adrenergic blockers, for at least 2 weeks prior to screening or is likely to change during the course of the study.
- Patient is pregnant, lactating, or plans to become pregnant during the course of the study.
- Patient refuses to provide written informed consent.
- Patient is not at least 18 years of age.
- Patient is not available for the follow-up evaluations as required by the protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cook MyoSitelead
Study Sites (29)
Mayo Clinic Arizona Phoenix Campus
Phoenix, Arizona, 85054, United States
The American Association of Female Pelvic Medicine Specialists
Agoura Hills, California, 91301, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90024, United States
Stanford University
Stanford, California, 94304, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Emory University
Atlanta, Georgia, 30033, United States
NorthShore University HealthSystem
Skokie, Illinois, 60076, United States
IU Health Physicians Urogynecology
Indianapolis, Indiana, 46202, United States
Female Pelvic Medicine & Urogynecology Institute of Michigan
Grand Rapids, Michigan, 49503, United States
Mercy Health Saint Mary's Campus
Grand Rapids, Michigan, 49503, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
NYU Urology Associates
New York, New York, 10016, United States
Premier Medical Group of the Hudson Valley PC
Poughkeepsie, New York, 12601, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
McKay Urology
Charlotte, North Carolina, 28207, United States
The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, 45242, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Greenville Health System
Greenville, South Carolina, 29607, United States
Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic
Sioux Falls, South Dakota, 57105, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Methodist Urology Associates
Houston, Texas, 77030, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Benaroya Research Institute at Virginia Mason
Seattle, Washington, 98101, United States
University Hospital Leuven
Leuven, 3000, Belgium
Universitätsklinikum Essen
Essen, 45147, Germany
Praxisklinik Urologie Rhein-Ruhr (PUR/R)
Mülheim, 45468, Germany
Related Publications (2)
Kaufman MR, Goldman HB, Chermansky CJ, Dmochowski R, Kennelly MJ, Peters KM, Quiroz LH, Bennett JB, Thomas S, Marguet CG, Benson KD, Lee UJ, Sokol ER, Wolter CE, Katz DM, Tarnay CM, Antosh D, Heit MH, Rehme C, Karram M, Snyder S, Canestrari E, Jankowski RJ, Chancellor MB. Iltamiocel Autologous Cell Therapy for the Treatment of Female Stress Urinary Incontinence: A Double-Blind, Randomized, Stratified, Placebo-Controlled Trial. Neurourol Urodyn. 2024 Nov;43(8):2290-2299. doi: 10.1002/nau.25588. Epub 2024 Sep 16.
PMID: 39282854DERIVEDAntosh DD, High R, Brown HW, Oliphant SS, Abed H, Philip N, Grimes CL. Feasibility of prophylactic salpingectomy during vaginal hysterectomy. Am J Obstet Gynecol. 2017 Nov;217(5):605.e1-605.e5. doi: 10.1016/j.ajog.2017.07.017. Epub 2017 Jul 20.
PMID: 28734829DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ron Jankowski, PhD
- Organization
- Cook MyoSite, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Melissa Kaufman, M.D., Ph.D.
Vanderbilt University Medical Center, Department of Urologic Surgery
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
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
Study Record Dates
First Submitted
July 2, 2013
First Posted
July 8, 2013
Study Start
November 21, 2013
Primary Completion
November 1, 2019
Study Completion
November 10, 2020
Last Updated
January 5, 2023
Results First Posted
January 5, 2023
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share