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Enrolling by Invitation

NCT Number: NCT06743620

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

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.

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Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–100 year

Sex eligibility

Female

Study type

Observational

Primary location

Virtual Site

Harvard, Massachusetts, 01451, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

iltamiocel

Other

This is an observational study with no intervention.

Primary outcomes

  1. Long term safety

    Time frame: 5 years

    Long term safety of iltamiocel

  2. Long term effectiveness

    Time frame: 5 years

    Long term effectiveness of iltamiocel

Sponsors and collaborators

Lead sponsor

Cook MyoSite

Industry

Registry information

Official study 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

Acronym: CLBT RGST

Important dates

Study start
2025
Primary completion
2032
Study completion
2032
First posted
Dec 20, 2024
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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