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Autologous Muscle Stem Cell Therapy for Treatment of Congenital Urinary Incontinence in Epispadias Patients
Sponsor: Simone Spuler, MD
Summary
The aim of this trial is to evaluate the safety and efficacy of an autologous muscle stem cell therapy in the treatment of congenital urinary incontinence in isolated epispadias.
Official title: Combined Phase 1 and 1/2a Clinical Trial Evaluating the Safety and Efficacy of an Autologous Muscle Stem Cell Therapy in the Treatment of Urinary Incontinence in Isolated Epispadias
Key Details
Gender
MALE
Age Range
3 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
21
Start Date
2024-06
Completion Date
2026-10
Last Updated
2023-08-03
Healthy Volunteers
No
Conditions
Interventions
Primary human muscle stem cells (Satori-01)
Primary human muscle stem cells are isolated from patient's muscle tissue and expanded ex-vivo. They are injected into the urethral sphincter region as a one-time autologous treatment.
Placebo
Placebo is the injection solution without muscle stem cells.
Locations (2)
Clinic for Pediatric Urology in cooperation with University Hospital Regensburg, St. Hedwig Hospital
Regensburg, Germany
Pediatric Urology, Department for Urology University of Ulm
Ulm, Germany