Outcomes of Autologous Bone Marrow Mononuclear Cell Administration in the Treatment of Neurologic Sequelea in Children With Spina Bifida

Autologous Bone Marrow Mononuclear Cell Administration in the Treatment of Neurologic Sequela in Children With Spina Bifida

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05472428

Enrollment

Registered

2022-07-25

Start date

2016-07-01

Completion date

2021-08-31

Last updated

2022-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stem Cell Infusion

Keywords

Spina bifida, mononuclear cell, neurologic sequelea

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

Interventions

COMBINATION_PRODUCTAutologous bone marrow mononuclear cell transplantation

Transplantation of Autologous Bone Marrow Mononuclear cells

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Masking description

Open Label

Eligibility

Sex/Gender

ALL

Age

6 Months to 15 Years

Healthy volunteers

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). * Distress

Design outcomes

Primary

Measure	Time frame	Description
Adverse events and serious adverse events	up to the 12-month period following treatment	Incidence of the adverse events or serious adverse events after infusion

Secondary

Measure	Time frame	Description
Rectoanal inhibitory reflex	up to the 12-month period following treatment	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
Bladder sensation	up to the 12-month period following treatment	The cystometry was used to assess bladder sensation
Bristol stool scale	up to the 12-month period following treatment	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.
Urinary incontinence	up to the 12-month period following treatment	Urinary incontinence is assessed via cytometry
Lower limb motor functions	up to the 12-month period following treatment	Lower limb motor function was assessed via manual muscle testing (MMT)
Urinary retention	up to the 12-month period following treatment	urinary retention is assessed via cytometry

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026