NCT06743620

Observational Registry for Iltamiocel Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence

Enrolling by Invitation
Not specifiedAges 18+Observational
Cook MyoSite
~96 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:iltamiocel

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Long term safety
Measured over 5 years
+1 more outcome measured
Stress Urinary Incontinence
1 sites across 1 states
Massachusetts1
  • Ron Jankowski, PhD · STUDY_DIRECTOR · Cook MyoSite, Inc.

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

Has only received placebo as part of the CLBT study.
Unable or unwilling to provide informed consent.
  • Long term safety5 years

    Long term safety of iltamiocel

  • Long term effectiveness5 years

    Long term effectiveness of iltamiocel