NCT05472428
Completed
Phase 1
Autologous Bone Marrow Mononuclear Cell Administration in the Treatment of Neurologic Sequela in Children With Spina Bifida
Vinmec Research Institute of Stem Cell and Gene Technology1 site in 1 country11 target enrollmentJuly 1, 2016
ConditionsStem Cell Infusion
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Stem Cell Infusion
- Sponsor
- Vinmec Research Institute of Stem Cell and Gene Technology
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Adverse events and serious adverse events
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The aim of this study was to evaluate the safety and efficacy of autologous bone marrow mononuclear cell infusion in the management of neurological sequelae in children with spina bifida
Detailed Description
The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear cells in 11 patients with spina bifida at Vinmec Research Institute of Stem Cell and Gene Technology in Hanoi, Vietnam from 2016 to 2020
Investigators
Eligibility Criteria
Inclusion Criteria
- •The patient who was diagnosed with lumbar spina bifida underwent spinal cord close-up surgery.
- •Both genders.
- •Aged between 6 months and 15 years old.
- •Exhibited bowel disorders (constipation, fecal incontinence) and urinary dysfunction (urinary retention or leakage).
Exclusion Criteria
- •Vertebrae clefts in the chest, neck, and other spinal locations.
- •Coagulopathy.
- •Acute and chronic infection.
- •Kidney function disorder, liver failure
- •Patients with complex cardiovascular diseases (including valvular heart disease, cardiomyopathy, arrhythmia, congenital heart disease, hypertrophy syndrome).
Outcomes
Primary Outcomes
Adverse events and serious adverse events
Time Frame: up to the 12-month period following treatment
Incidence of the adverse events or serious adverse events after infusion
Secondary Outcomes
- Lower limb motor functions(up to the 12-month period following treatment)
- Rectoanal inhibitory reflex(up to the 12-month period following treatment)
- Bladder sensation(up to the 12-month period following treatment)
- Urinary retention(up to the 12-month period following treatment)
- Bristol stool scale(up to the 12-month period following treatment)
- Urinary incontinence(up to the 12-month period following treatment)
Study Sites (1)
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