Autologous Muscle Stem Cell Therapy for Treatment of Congenital Urinary Incontinence in Epispadias Patients
NCT ID: NCT04729582
Last Updated: 2023-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
21 participants
INTERVENTIONAL
2024-06-30
2026-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Verum Group
Participants receive primary human muscle stem cells as one-time injection into the urethral sphincter region under visual control using cystoscopy.
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 group
Participants receive placebo solution as one-time injection into the external urethral sphincter region under visual control using cystoscopy.
Placebo
Placebo is the injection solution without muscle stem cells.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Isolated epispadias
* Aged ≥ 3 years
* Urinary incontinence as defined according to the International Children´s Continence Society
* Informed consent
Exclusion Criteria
* Coagulation Disorder
* Previous adverse reaction to anesthesia
* Congenital heart defect, cardiac arrhythmia
3 Years
17 Years
MALE
No
Sponsors
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German Federal Ministry of Education and Research
OTHER_GOV
Simone Spuler, MD
OTHER
Responsible Party
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Simone Spuler, MD
Principal investigator
Principal Investigators
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Anne K Ebert, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Pediatric Urology, Department for Urology University of Ulm, Germany
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MUST
Identifier Type: -
Identifier Source: org_study_id
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