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
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Transplantation of Autologous Bone Marrow Mononuclear cells
Vinmec Research Institute of Stem Cell and Gene Technology
Hanoi, Vietnam
Adverse events and serious adverse events
Incidence of the adverse events or serious adverse events after infusion
Time frame: up to the 12-month period following treatment
Bristol stool scale
The Bristol stool scale comes in 7 types: Type 1-2 indicate constipation; type 3-4 are ideal stools as they are easier to pass; type 5-7 may show diarrhea and urgency.
Time frame: up to the 12-month period following treatment
Rectoanal inhibitory reflex
The rectoanal inhibitory reflex (RAIR) is a reflex characterized by transient involuntary relaxation of the internal anal sphincter in response to distention of the rectum with the normal value \<= 14.7 ml
Time frame: up to the 12-month period following treatment
Bladder sensation
The cystometry was used to assess bladder sensation
Time frame: up to the 12-month period following treatment
Urinary retention
urinary retention is assessed via cytometry
Time frame: up to the 12-month period following treatment
Urinary incontinence
Urinary incontinence is assessed via cytometry
Time frame: up to the 12-month period following treatment
Lower limb motor functions
Lower limb motor function was assessed via manual muscle testing (MMT)
Time frame: up to the 12-month period following treatment
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