Autologous Muscle Stem Cell Therapy for Treatment of Congenital Urinary Incontinence in Epispadias Patients
Launched by SIMONE SPULER, MD · Jan 27, 2021
Trial Information
Current as of July 05, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is testing a new treatment for boys who have congenital urinary incontinence due to a condition called epispadias. The treatment uses muscle stem cells taken from the patient's own body, which means they are called "autologous." The goal of the trial is to see if this therapy is safe and effective in helping improve urinary control in these patients.
To participate in this trial, boys must be at least 3 years old and diagnosed with isolated epispadias, which is a rare condition affecting the urinary system. Participants will need to provide informed consent, meaning they or their guardians will agree to be part of the study after understanding what it involves. However, boys with certain health issues, such as ongoing infections or heart problems, will not be eligible. Since the trial is not yet recruiting, there will be more information available soon for families considering this option.
Gender
MALE
Eligibility criteria
- 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
About Simone Spuler, Md
Dr. Simone Spuler, MD, is a distinguished clinical trial sponsor known for her expertise in advancing medical research and innovative therapies. With a strong background in clinical medicine and a commitment to improving patient outcomes, Dr. Spuler leads initiatives that focus on the development and evaluation of novel treatments across various therapeutic areas. Her dedication to rigorous scientific methodology and ethical standards ensures that all trials under her sponsorship prioritize patient safety and contribute valuable insights to the medical community. Through collaborative partnerships and a patient-centered approach, Dr. Spuler strives to translate research findings into meaningful clinical applications.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Regensburg, , Germany
Ulm, , Germany
Patients applied
Trial Officials
Anne K Ebert, Prof. Dr.
Principal Investigator
Pediatric Urology, Department for Urology University of Ulm, Germany
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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