NCT04729582View on ClinicalTrials.gov

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

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

June 30, 2024

Primary Completion Date

August 31, 2026

Study Completion Date

October 31, 2026

Conditions
Urinary IncontinenceEpispadias, Male
Interventions
BIOLOGICAL

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.

OTHER

Placebo

Placebo is the injection solution without muscle stem cells.

Trial Locations (2)

89075

Pediatric Urology, Department for Urology University of Ulm, Ulm

93049

Clinic for Pediatric Urology in cooperation with University Hospital Regensburg, St. Hedwig Hospital, Regensburg

All Listed Sponsors
collaborator

German Federal Ministry of Education and Research

OTHER_GOV

lead

Simone Spuler, MD

OTHER

NCT04729582 - Autologous Muscle Stem Cell Therapy for Treatment of Congenital Urinary Incontinence in Epispadias Patients | Biotech Hunter | Biotech Hunter