Autologous Muscle Derived Cells for Female Urinary Sphincter Repair

Study Overview
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Brief Summary
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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.

Detailed Description
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Study comparing intrasphincteric injection of iltamiocel with placebo. Subjects unblinded after 12 month visits, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.

Official Title
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A Double-blind, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR With Placebo in Female Subjects With Stress Urinary Incontinence

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Other: Placebo
* Biological: Iltamiocel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo control is the vehicle solution used for the study product. | Other: Placebo<br>* Placebo control is the vehicle solution used for the study product.<br>|
| Experimental: Iltamiocel<br>AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10^6 cells. | Biological: Iltamiocel<br>* AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10^6 cells.<br>* Other names: Autologous muscle-derived cells (AMDC);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary Incontinence, Stress, Tissue Therapy (Cell Therapy), Transplantation, Autologous