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Trial record 1 of 1 for:    Cellebrate
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Adaptive Design Study of Autologous Muscle Derived Cells Compared to Placebo for Female Urinary Sphincter Repair for Persistent or Recurrent Stress Urinary Incontinence Following Surgical Treatment (CELLEBRATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03104517
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : April 18, 2023
Sponsor:
Information provided by (Responsible Party):
Cook MyoSite

Study Description
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Brief Summary:
This study evaluates the efficacy and safety of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR; generic name: iltamiocel) compared to a placebo in the reduction of stress incontinence episode frequency in adult female patients with post-surgical persistent or recurrent stress urinary incontinence (SUI). 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 (iltamiocel) 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; generic name: iltamiocel) 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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CELLEBRATE: An Adaptive, Two-Stage, Double-Blind, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR With Placebo in Female Subjects With Persistent or Recurrent Stress Urinary Incontinence Following Surgical Treatment
Actual Study Start Date : April 23, 2019
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : February 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: AMDC-USR (iltamiocel)
Autologous muscle-derived cells for urinary sphincter repair (AMDC-USR; generic name: iltamiocel) is the study product.
 Biological: AMDC-USR (iltamiocel)
Autologous Muscle Derived Cells for Urinary Sphincter Repair (generic name: iltamiocel)
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
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Primary Outcome Measures :
  1. Number of leaks due to stress incontinence episodes, as recorded in a diary [ Time Frame: 12 months ]
    Stress leak frequency


Eligibility Criteria
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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:

  • Adult female patient ≥ 18 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.
  • History of previous surgery for treatment of SUI. Previous surgery could include midurethral sling, retropubic suspension, or bladder neck sling. Bulking agents alone are not considered previous surgery for treatment of SUI.
  • 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
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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): NCT03104517


Contacts
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Contact: Kimberly Dawn Rogers, R.N. 866-267-4479 Kimberly.Rogers@IQVIA.com
Contact: Christina Scheuerman, BSN, RN 513-520-1459 Christina.Scheuerman@IQVIA.com

Locations
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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
More Information
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Additional Information:

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Responsible Party: Cook MyoSite
ClinicalTrials.gov Identifier: NCT03104517    
Other Study ID Numbers: 15-06
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: April 18, 2023
Last Verified: April 2023
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
Keywords provided by Cook MyoSite:
Urinary Incontinence
Urinary Stress Incontinence
Lower Urinary Tract Symptoms
Urinary Bladder
Urinary Tract Diseases
Bladder
Urinary Leak
Urine Leak
 Bladder Leak
Urethra
Urethral Sphincter
Persistent Incontinence
Recurrent Incontinence
Incontinence Surgery
Sling Surgery
Stress Urinary Incontinence Surgery
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