Stress Urinary IncontinencePhase 3CELLEBRATENCT03104517
Autologous Muscle Derived Cells Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence
A Phase 3 study testing AMDC-USR (iltamiocel) in people with Stress Urinary Incontinence, run by Cook MyoSite at 21 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- AMDC-USR (iltamiocel)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 21 sitesin 2 countries
- Study dates
- 23 Apr 2019to Nov 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States20 sites
University of New Mexico Women's Care Clinic
Albuquerque, New Mexico, 87131
Atrium Health
Charlotte, North Carolina, 20207
Cleveland Clinic/Glickman Institute-Q10
Cleveland, Ohio, 44195
AccuMed Research Associates
Garden City, New York, 11530
Bennett Institute of Urogynecology and Incontinence
Grand Rapids, Michigan, 49456
Houston Methodist Hospital
Houston, Texas, 77030
Cedar Health Research
Irving, Texas, 75062
University of Kansas Health System
Kansas City, Kansas, 66160
San Diego Clinical Trials
La Mesa, California, 91942
Northwell Health/The Arthur Smith Institute for Urology
Lake Success, New York, 11042
UCLA Women's Health Clinical Research Unit/Department of OBGYN
Los Angeles, California, 90095
Vanderbilt University Medical Center, Dept. of Urologic Surgery
Nashville, Tennessee, 37232
Columbia University Irving Medical Center
New York, New York, 10032
Magee Women's Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
Virginia Mason Medical Center
Seattle, Washington, 98101
Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic
Sioux Falls, South Dakota, 57105
Stanford Hospital and Clinics
Stanford, California, 94305
Del Sol Research Management, LLC
Tucson, Arizona, 85715
MedStar Georgetown Hospital Department of Urology
Washington D.C., District of Columbia, 20007
American Association of Female Pelvic Medicines Research Institute
Westlake Village, California, 91361
About this study
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
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.
Read the 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).
- Conditions
- Stress Urinary Incontinence
- Being tested
- AMDC-USR (iltamiocel), Placebo
- Keywords
- 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
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence, Lower Urinary Tract Symptoms, Urologic Diseases, Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMDC-USR (iltamiocel)Biological
Autologous Muscle Derived Cells for Urinary Sphincter Repair (generic name: iltamiocel)
PlaceboOther
Placebo control is the vehicle solution used for the study product.
| Study group | Role | What they receive |
|---|---|---|
| AMDC-USR (iltamiocel) | Experimental | Autologous muscle-derived cells for urinary sphincter repair (AMDC-USR; generic name: iltamiocel) is the study product. Receives: Biological: AMDC-USR (iltamiocel) |
| Placebo | Placebo comparator | Placebo control is the vehicle solution used for the study product. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of leaks due to stress incontinence episodes, as recorded in a diary
Stress leak frequency
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start23 Apr 2019
- Primary completion11 Jun 2026
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cook MyoSite
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Melissa Kaufman, M.D., Ph.D., Principal investigator, Vanderbilt University Medical Center, Department of Urologic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104517
- Sponsor's protocol ID
- 15-06
- Acronym
- CELLEBRATE
- Status last verified
- Oct 2026
- First submitted
- 3 Apr 2017
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03104517
- Acronym / sponsor ID
- CELLEBRATE / 15-06
- Conditions
- Stress Urinary Incontinence
- Keywords
- Urinary Incontinence, Urinary Stress Incontinence, Lower Urinary Tract Symptoms, Urinary Bladder, Urinary Tract Diseases, Bladder, Urinary Leak, Urine Leak
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Cook MyoSiteIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 11 Jun 2026 (actual)
- Study completion
- Nov 2026 (estimated)
- First posted
- 7 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMDC-USR (iltamiocel) | Experimental | Biological: AMDC-USR (iltamiocel)Autologous muscle-derived cells for urinary sphincter repair (AMDC-USR; generic name: iltamiocel) is the study product. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo control is the vehicle solution used for the study product. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMDC-USR (iltamiocel)Autologous Muscle Derived Cells for Urinary Sphincter Repair (generic name: iltamiocel) | Biological | AMDC-USR (iltamiocel) |
| PlaceboPlacebo control is the vehicle solution used for the study product. | Other | Placebo |
Primary outcome
Number of leaks due to stress incontinence episodes, as recorded in a diary
Time frame: 12 months
Stress leak frequency
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- https://www.suiclinicalstudy.com/Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Kaufman, M.D., Ph.D. principal investigator
Vanderbilt University Medical Center, Department of Urologic Surgery
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AMDC-USR (iltamiocel) in people with Stress Urinary Incontinence, run by Cook MyoSite at 21 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of leaks due to stress incontinence episodes, as recorded in a diary (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.