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Japanese Bridging Study of Autologous Muscle Derived Cells Compared to Placebo for Female Urinary Sphincter Repair(JPN1) (JPN1)

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ClinicalTrials.gov Identifier: NCT03997318
Recruitment Status : Not yet recruiting
First Posted : June 25, 2019
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Cook MyoSite

Brief Summary:
This is a confirmatory/bridging study to evaluate the efficacy and safety of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) compared with placebo in the treatment of stress urinary incontinence (SUI) in adult Japanese female subjects. Half of the participants will receive AMDC-USR (injections with cells) and the other half will receive placebo.

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Biological: AMDC-USR Other: Placebo Phase 3

Detailed Description:

Stress urinary incontinence (SUI) is the accidental loss of urine due to physical activity, such as laughing, coughing, or sneezing. Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) involves a medical procedure in which a participant's own muscle cells are collected, processed, and then injected into the tissues of the urinary passage.

This is a double-blind randomized study, which means neither the participant, nor the study doctor will know which treatment group the participant will be in. Participants who are randomly chosen to receive injection with placebo will have the option to receive an injection with their cells after completion of the blinded portion of their study participation (12 months).

This trial was designed as a confirmatory Phase III study to bridge efficacy and safety data from the Japanese population to the current Phase III global trial for AMDC-USR (CELLBRATE, NCT03104517).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: JPN1: A Confirmatory, Bridging, Double-Blind, Randomized, Controlled Trial in Japan Comparing the Safety and Efficacy of AMDC-USR With Placebo in Female Subjects With Stress Urinary Incontinence
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AMDC-USR
AMDC-USR is the study product (Autologous Muscle Derived Cells for Urinary Sphincter Repair).
Biological: AMDC-USR
Autologous Muscle Derived Cells for Urinary Sphincter Repair

Placebo Comparator: Placebo
Placebo control is the vehicle solution used for the study product.
Other: Placebo
Placebo control is the vehicle solution used for the study product.




Primary Outcome Measures :
  1. Number of leaks due to stress incontinence episodes, as recorded in a diary. [ Time Frame: 12 months ]
    Stress leak frequency



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult female patient 50 to 75 years of age who has primary and moderate-to-severe symptoms of SUI for at least 6 months, as confirmed by patient medical history and clinical symptoms, including a focused incontinence evaluation.
  • Must be willing and able to comply with the study procedures, be mentally competent and able to understand all study requirements, and must agree to read and sign the informed consent form prior to any study-related procedures.
  • Must have completed 100% of the screening 3-day diary evening reports.

Exclusion Criteria:

  • Patient has symptoms of only 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, pelvic floor muscle therapy, etc.)
  • Patient BMI ≥ 35.
  • Patient routinely has more than 2 episodes of awakening to void during normal sleeping hours.
  • If taking a medication known to affect lower urinary tract function, including but not limited to, anticholinergics, beta 3 adrenergic receptor agonists, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitor (SNRI) or selective serotonin reuptake inhibitor (SSRI) antidepressants, diuretics, or alpha-adrenergic blockers, patient cannot be maintained on a stable dose and/or frequency of medication (including diuretics), cannot be maintained on a stable dose and/or frequency for at least 2 weeks prior to screening or is likely to change during the course of the study.
  • History of cancer in pelvic organs, ureters, or kidneys.
  • Patient is pregnant, lactating, or plans to become pregnant during the course of the study.

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): NCT03997318


Contacts
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Contact: Tomoko Kubota +81-80-4329-0972 Tomoko.kubota@iqvia.com

Sponsors and Collaborators
Cook MyoSite
Investigators
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Principal Investigator: Melissa Kaufman, M.D., Ph.D. Vanderbilt University Medical Center, Department of Urologic Surgery

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Responsible Party: Cook MyoSite
ClinicalTrials.gov Identifier: NCT03997318     History of Changes
Other Study ID Numbers: 15-09
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Cook MyoSite:
Lower Urinary Tract Symptoms
Urinary Incontinence
Urinary Stress Incontinence
Urinary Bladder
Urinary Tract Diseases
Bladder
Urinary Leak
Urine Leak
Bladder Leak
Urethra
Urethral Spincter

Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders