Autologous Muscle Derived Cells for Female Urinary Sphincter Repair
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| ClinicalTrials.gov Identifier: NCT01893138 |
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Recruitment Status :
Completed
First Posted : July 8, 2013
Results First Posted : January 5, 2023
Last Update Posted : January 5, 2023
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Sponsor:
Cook MyoSite
Information provided by (Responsible Party):
Cook MyoSite
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Stress Urinary Incontinence | Other: Placebo Biological: Iltamiocel | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 311 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | November 21, 2013 |
| Actual Primary Completion Date : | November 1, 2019 |
| Actual Study Completion Date : | November 10, 2020 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
Placebo control is the vehicle solution used for the study product.
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Other: Placebo
Placebo control is the vehicle solution used for the study product. |
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Experimental: Iltamiocel
AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10^6 cells.
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Biological: Iltamiocel
AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10^6 cells.
Other Name: Autologous muscle-derived cells (AMDC) |
Primary Outcome Measures :
- Participants With ≥ 50% Reduction in Stress Incontinence Episode Frequency From Baseline to 12 Months Post-treatment; as Assessed by 3 Day Diary [ Time Frame: Baseline and 12 months ]
Secondary Outcome Measures :
- Participants With at ≥ 75% Reduction in Stress Incontinence Episodes From Baseline at 12 Months [ Time Frame: Baseline and 12 months ]
- Participants With 0 or 1 Stress Incontinence Episodes Based on 3 Day Diary Records at 12 Months [ Time Frame: Baseline and 12 months ]
- Change in the Frequency of Stress Incontinence Episodes From Baseline at 12 Months [ Time Frame: Baseline and 12 months ]
Other Outcome Measures:
- Association of Change in Quality of Life Scores With Change in Stress Incontinence Episode Frequency [ Time Frame: Baseline and 12 months ]Spearman's correlation used for analysis
- Treatment Durability at 24 Months [ Time Frame: Baseline, 12 months, and 24 months after injection with iltamiocel ]Treatment durability defined as iltamiocel-treated participants with reduction in stress incontinence episode frequency (SIEF) at 12 months who maintained that response at 24 months
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Female patient has primary symptoms of SUI, as confirmed by patient medical history and clinical symptoms, including a focused incontinence evaluation.
Exclusion Criteria:
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01893138
Locations
Show 29 study locations
Sponsors and Collaborators
Cook MyoSite
Investigators
| Principal Investigator: | Melissa Kaufman, M.D., Ph.D. | Vanderbilt University Medical Center, Department of Urologic Surgery |
Study Documents (Full-Text)
Documents provided by Cook MyoSite:
Documents provided by Cook MyoSite:
Study Protocol and Statistical Analysis Plan [PDF] February 18, 2016
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Cook MyoSite |
| ClinicalTrials.gov Identifier: | NCT01893138 |
| Other Study ID Numbers: |
13-003 |
| First Posted: | July 8, 2013 Key Record Dates |
| Results First Posted: | January 5, 2023 |
| Last Update Posted: | January 5, 2023 |
| Last Verified: | December 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Cook MyoSite:
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Urinary Incontinence, Stress Tissue Therapy (Cell Therapy) Transplantation, Autologous |
Additional relevant MeSH terms:
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Urinary Incontinence Enuresis Urinary Incontinence, Stress Urination Disorders Urologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications |
Urogenital Diseases Male Urogenital Diseases Lower Urinary Tract Symptoms Urological Manifestations Behavioral Symptoms Elimination Disorders Mental Disorders |