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

Cook MyoSite1 site in 1 country96 target enrollmentApril 11, 2025

ConditionsStress Urinary Incontinence

Overview

Phase: N/A
Intervention: Not specified
Conditions: Stress Urinary Incontinence
Sponsor: Cook MyoSite
Enrollment: 96
Locations: 1
Primary Endpoint: Long term safety
Status: Enrolling by Invitation
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 11, 2025

End Date

April 2032

Last Updated

last year

Study Type

Observational

Sex

Female

Investigators

Sponsor

Cook MyoSite

Responsible Party

Sponsor

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