Observational Registry for Iltamiocel Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence
Launched by COOK MYOSITE · Dec 17, 2024
Trial Information
Current as of June 09, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
No description provided
Gender
FEMALE
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.
About Cook Myosite
Cook Myosite is a leading clinical trial sponsor focused on advancing innovative therapies for muscle repair and regeneration. With a commitment to improving patient outcomes, the company specializes in developing cutting-edge technologies and biologics that harness the body's natural healing processes. Cook Myosite collaborates with healthcare professionals and research institutions to conduct rigorous clinical trials, ensuring that their products are safe, effective, and aligned with the highest regulatory standards. Their dedication to scientific excellence and patient care positions them at the forefront of regenerative medicine.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Harvard, Massachusetts, United States
Patients applied
Trial Officials
Ron Jankowski, PhD
Study Director
Cook MyoSite, Inc.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported