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Completed

NCT Number: NCT05472428

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

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

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Key information

Conditions

Stem Cell Infusion Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Nervous System Diseases Nervous System Malformations Neural Tube Defects Spinal Dysraphism

Age range

6 month–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, 100000, Vietnam

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous bone marrow mononuclear cell transplantation

Combination Product

Transplantation of Autologous Bone Marrow Mononuclear cells

Primary outcomes

  1. 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

  1. Bristol stool scale

    Time frame: 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.

  2. Rectoanal inhibitory reflex

    Time frame: 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

  3. Bladder sensation

    Time frame: up to the 12-month period following treatment

    The cystometry was used to assess bladder sensation

  4. Urinary retention

    Time frame: up to the 12-month period following treatment

    urinary retention is assessed via cytometry

  5. Urinary incontinence

    Time frame: up to the 12-month period following treatment

    Urinary incontinence is assessed via cytometry

  6. Lower limb motor functions

    Time frame: up to the 12-month period following treatment

    Lower limb motor function was assessed via manual muscle testing (MMT)

Sponsors and collaborators

Lead sponsor

Vinmec Research Institute of Stem Cell and Gene Technology

Other

Collaborators

  • Vinmec Health Care System (Vingroup Joint Stock Company)

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Jul 25, 2022
Registry last updated
Jul 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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