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

Vinmec Research Institute of Stem Cell and Gene Technology

Status and phase: Completed; Phase 1

Conditions: Stem Cell Infusion

Treatments: Combination Product: Autologous bone marrow mononuclear cell transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT05472428

CS. ĐT.19H1

Details and patient eligibility

About

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

Full 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

Enrollment: 11 patients

Sex: All

Ages: 6 months to 15 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Autologous BMMNC transplantation

Experimental group

Description:

- Autologous bone marrow mononuclear cell transplantation 2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 6 months afterward

Treatment:

Combination Product: Autologous bone marrow mononuclear cell transplantation