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

Sponsor
Cook MyoSite (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT03997318
Collaborator
(none)
24
2
24

Study Details

Study Description

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
  • 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).

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Number of leaks due to stress incontinence episodes, as recorded in a diary. [12 months]

    Stress leak frequency

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

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)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cook MyoSite
ClinicalTrials.gov Identifier:
NCT03997318
Other Study ID Numbers:
  • 15-09
First Posted:
Jun 25, 2019
Last Update Posted:
Feb 17, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 17, 2022