A Phase 1/2 interventional study of Primary human muscle stem cells (Satori-01) and Placebo in Urinary Incontinence and Epispadias, Male, sponsored by Simone Spuler, MD. Not yet recruiting at 2 sites in Germany. Open to male participants aged 3 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-08-03.
Sponsored by Simone Spuler, MD · Phase 1/2, Interventional, and Treatment
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.
Epispadias is the mildest form of exstrophy-epispadias complex (EEC); a congenital malformation disorder involving the midline abdominal and genitourinary structures. Patients with epispadias have a defect in the urethral sphincter resulting in urinary incontinence. This trial investigates the injection of autologous primary human muscle stem cells into the urethral sphincter with the aim of repairing the defect and restore the anatomic ability for continence.
Eligible participants will undergo muscle biopsy during a routine cystoscopy. Acquired muscle tissue is used for the isolation and expansion of muscle stem cells ex-vivo. Muscle stem cells are injected into the urethral sphincter under visual control using cystoscopy. Participants are assessed for safety and efficacy for a minimum of 12 months post-intervention.
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's planned enrollment of 21 is below the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Simone Spuler, MD is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants receive primary human muscle stem cells as one-time injection into the urethral sphincter region under visual control using cystoscopy.
Biological: Primary human muscle stem cells (Satori-01)
Participants receive placebo solution as one-time injection into the external urethral sphincter region under visual control using cystoscopy.
Other: Placebo
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 is the injection solution without muscle stem cells.
Prevalence of Intervention-related Adverse Events
Characterization of type, incidence, severity, and duration of adverse events
Time frame: Upto 12 months post-intervention
Change in Leak Point Pressure (LPP)
Change in LPP is calculated from baseline measurement
Time frame: Six months post-intervention
This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Simone Spuler, MD