Stress Urinary IncontinenceCLBT RGSTNCT06743620
Observational Registry for Iltamiocel Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence
An observational study of Stress Urinary Incontinence, run by Cook MyoSite at 1 site in United States.
Trial summary
The main purpose of this registry is to collect observational, long-term safety and effectiveness data in subjects who have received at least one dose of iltamiocel as part of the CLBT clinical study. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- iltamiocel
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2025to Apr 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female subjects who have received iltamiocel as part of participation in the CLBT clinical study for females with persistent or recurrent SUI following surgical treatment will be considered for enrollment.
Who may be able to join
- Has completed participation within 15 months in the CLBT clinical study for females with persistent or recurrent SUI following surgical treatment (i.e., either subject has completed all follow-up visits or has been officially exited from the study).
- Has received at least one dose of iltamiocel as part of the CLBT study.
- Must be willing and able to comply with the study procedures, is able to understand all study requirements and must agree to read and sign the informed consent form prior to any study-related procedures.
- Has access to a phone or electronic device to allow completion of electronic documents
Who cannot join
- Has only received placebo as part of the CLBT study.
- Unable or unwilling to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Observational Long-Term Safety and Effectiveness Registry of Patients Who Have Received Iltamiocel as Part of Cook Myosite, Inc. Sponsored CELLEBRATE Clinical Study in Patients With Persistent or Recurrent Stress Urinary Incontinence (SUI) Following Surgical Treatment
The main purpose of this registry is to collect observational, long-term safety and effectiveness data in subjects who have received at least one dose of iltamiocel as part of the CLBT clinical study.
- Conditions
- Stress Urinary Incontinence
- Being tested
- iltamiocel
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iltamiocelOther
This is an observational study with no intervention.
| Study group | Role | What they receive |
|---|---|---|
| Patients with persistent or recurrent SUI following surgical treatment who have received iltamiocel | Not described Receives: Other: iltamiocel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term safety
Long term safety of iltamiocel
Measured: 5 years
Long term effectiveness
Long term effectiveness of iltamiocel
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start11 Apr 2025
- Primary completionApr 2032 (estimated)
- Study completionApr 2032 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Cook MyoSite
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ron Jankowski, PhD, Study director, Cook MyoSite, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743620
- Sponsor's protocol ID
- R15-06
- Acronym
- CLBT RGST
- Status last verified
- Jul 2026
- First submitted
- 17 Dec 2024
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Long-Term Safety and Effectiveness Registry of Patients Who Have Received Iltamiocel as Part of Cook Myosite, Inc. Sponsored CELLEBRATE Clinical Study in Patients With Persistent or Recurrent Stress Urinary Incontinence (SUI) Following Surgical Treatment
- ClinicalTrials.gov ID
- NCT06743620
- Acronym / sponsor ID
- CLBT RGST / R15-06
- Conditions
- Stress Urinary Incontinence
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Cook MyoSiteIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- Apr 2032 (estimated)
- Study completion
- Apr 2032 (estimated)
- First posted
- 20 Dec 2024 (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.
The main purpose of this registry is to collect observational, long-term safety and effectiveness data in subjects who have received at least one dose of iltamiocel as part of the CLBT clinical study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with persistent or recurrent SUI following surgical treatment who have received iltamiocel | – | Other: iltamiocel |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female subjects who have received iltamiocel as part of participation in the CLBT clinical study for females with persistent or recurrent SUI following surgical treatment will be considered for enrollment.
Key inclusion criteria (4 listed)
- Has completed participation within 15 months in the CLBT clinical study for females with persistent or recurrent SUI following surgical treatment (i.e., either subject has completed all follow-up visits or has been officially exited from the study).
- Has received at least one dose of iltamiocel as part of the CLBT study.
- Must be willing and able to comply with the study procedures, is able to understand all study requirements and must agree to read and sign the informed consent form prior to any study-related procedures.
- Has access to a phone or electronic device to allow completion of electronic documents
Key exclusion criteria (2 listed)
- Has only received placebo as part of the CLBT study.
- Unable or unwilling to provide informed consent.
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 |
|---|---|---|
| iltamiocelThis is an observational study with no intervention. | Other | Patients with persistent or recurrent SUI following surgical treatment who have received iltamiocel |
Primary outcome
Long term safety
Time frame: 5 years
Long term safety of iltamiocel
Long term effectiveness
Time frame: 5 years
Long term effectiveness of iltamiocel
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 22 Jul 2026.
- 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.
Ron Jankowski, PhD study director
Cook MyoSite, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Urinary Incontinence, run by Cook MyoSite at 1 site in United States.
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 2 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: enrolling by invitation, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Long term safety (time frame: 5 years). The study lists 2 primary outcomes in all. 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 22 Jul 2026.