Observational Registry for Iltamiocel Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: iltamiocel.
- Who it may be relevant to
- Registry conditions: Stress Urinary Incontinence. Basic parameters: 18 years — 100 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Other iltamiocel
This is an observational study with no intervention.
Primary outcome measures
- Long term safety [Time frame: 5 years]
- Long term effectiveness [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Has only received placebo as part of the CLBT study.
- Unable or unwilling to provide informed consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Virtual Site — Harvard
Identifiers
NCT: NCT06743620 · R15-06