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

Sponsor
Simone Spuler, MD
Study ID
NCT04729582
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Epispadias, Male
  • Urinary Incontinence

Eligibility Criteria

Sex
MALE
Age
3 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Primary human muscle stem cells (Satori-01) — BIOLOGICAL
    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 — OTHER
    Placebo is the injection solution without muscle stem cells.

Study Details

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.

Key Dates

First listed
Jan 28, 2021
Start date
Jun 30, 2024
Status verified
Aug 2023
Primary completion
Aug 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
21 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Verum Group
    Participants receive primary human muscle stem cells as one-time injection into the urethral sphincter region under visual control using cystoscopy.
  • Placebo Comparator: Placebo group
    Participants receive placebo solution as one-time injection into the external urethral sphincter region under visual control using cystoscopy.

Primary Outcome Measure

Prevalence of Intervention-related Adverse Events [ Time Frame: Upto 12 months post-intervention ]

Central Contacts

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