Autologous Muscle Stem Cell Therapy for Treatment of Congenital Urinary Incontinence in Epispadias Patients

NCT04729582 · tracked via the Priya Life Science Germany tracker

Sponsor

Simone Spuler, MD

Phase

Phase 1/2

Started

2024-06

Last updated

2023-08-03

Condition(s) studied

Urinary IncontinenceEpispadias, Male

Investigational drug(s) / intervention(s)

Primary human muscle stem cells (Satori-01)Placebo

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.

Study 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.

Eligibility

Sex

MALE

Min age

3 Years

Max age

17 Years

Healthy volunteers

Inclusion Criteria: * Male * Isolated epispadias * Aged ≥ 3 years * Urinary incontinence as defined according to the International Children´s Continence Society * Informed consent Exclusion Criteria: * Acute or chronic inflammatory local or systemic disease * Coagulation Disorder * Previous adverse reaction to anesthesia * Congenital heart defect, cardiac arrhythmia

Primary outcome measure(s)

Prevalence of Intervention-related Adverse Events — Upto 12 months post-intervention
Characterization of type, incidence, severity, and duration of adverse events
Change in Leak Point Pressure (LPP) — Six months post-intervention
Change in LPP is calculated from baseline measurement

Trial sites (2)

Facility	City	Region	Status
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

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04729582 on ClinicalTrials.gov ↗ ← All trials in Germany