Autologous Muscle Derived Cells Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence (CELLEBRATE)
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| ClinicalTrials.gov Identifier: NCT03104517 |
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Recruitment Status :
Recruiting
First Posted : April 7, 2017
Last Update Posted : May 7, 2024
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Sponsor:
Cook MyoSite
Information provided by (Responsible Party):
Cook MyoSite
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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 |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 96 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | CELLEBRATE: A 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
| Arm | Intervention/treatment |
|---|---|
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Experimental: AMDC-USR (iltamiocel)
Autologous muscle-derived cells for urinary sphincter repair (AMDC-USR; generic name: iltamiocel) is the study product.
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Biological: AMDC-USR (iltamiocel)
Autologous Muscle Derived Cells for Urinary Sphincter Repair (generic name: iltamiocel) |
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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. |
Primary Outcome Measures :
- 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: | 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.
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
| Contact: Maria Jose Godino | +54 911 3913 0952 | MariaJose.Godino@IQVIA.com |
Locations
Show 35 study locations
Sponsors and Collaborators
Cook MyoSite
Investigators
| Principal Investigator: | Melissa Kaufman, M.D., Ph.D. | Vanderbilt University Medical Center, Department of Urologic Surgery |
Additional Information:
| 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: | May 7, 2024 |
| Last Verified: | May 2024 |
| 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 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 |