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Completed

NCT Number: NCT04080921

Stem Cell Transplantation In-patient With Neurological Sequelae Due to Encephalitis or Meningitis

To evaluate the safety and efficacy of autologous bone marrow-derived mononuclear cell transplantation in-patient with neurological sequelae due to encephalitis or meningitis

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Key information

Conditions

Encephalitis Brain Diseases Central Nervous System Diseases Meningitis Nervous System Diseases Neuroinflammatory Diseases

Age range

2 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, 100000, Vietnam

About this study

The purpose of this study is to evaluate the safety and effectiveness of autologous bone marrow-derived mononuclear cell in 22 patients with neurological sequelae due to encephalitis or meningitis at Vinmec International Hospital, Hanoi, Vietnam

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Neurological sequelae due to encephalitis or meningitis

Exclusion criteria

  • Coagulation disorders
  • Allergy to anesthetic agents
  • Severe health conditions such as cancer, failure of heart, lung, liver or kidney
  • Active infections

Treatment and study plan

Stem cell transplantation

Combination Product

Transplantation of Autologous Bone Marrow Mononuclear Cells

Primary outcomes

  1. Change in Total Score of Gross Motor Function Measure (GMFM-88)

    Time frame: Baseline, 6 months, and 12 months after transplantation

    The Gross Motor Function Measure - 88 items (GMFM-88) is a standardized observational tool used to evaluate changes in gross motor function in children with cerebral palsy and other disabilities. The total score ranges from 0 to 264, with higher scores representing better gross motor function

  2. Change in Muscle Tone Assessed by Modified Ashworth Scale (MAS)

    Time frame: Baseline, 6 months, and 12 months after transplantation

    The Modified Ashworth Scale (MAS) is a clinical tool used to measure muscle tone and the degree of spasticity in patients with neurological conditions. The scale ranges from 0 to 4, with an additional 1+ category. Scores are interpreted as follows: 0 indicates no increase in muscle tone, 1 indicates a slight increase in muscle tone with a catch and release, 1+ indicates a slight increase with minimal resistance throughout the remainder of the range of motion, 2 indicates a more marked increase in muscle tone through most of the range of motion, 3 indicates considerable increase in muscle tone making passive movement difficult, and 4 indicates that the affected part(s) are rigid in flexion or extension. Lower scores represent better outcomes (normal muscle tone), while higher scores represent worse outcomes

Secondary outcomes

  1. Number of adverse events

    Time frame: Through study completion, an average of 12 months

    Examples of adverse events to look for: fever, infections, vomit, epilepsy

Sponsors and collaborators

Lead sponsor

Vinmec Research Institute of Stem Cell and Gene Technology

Other

Registry information

Official study title

The Outcomes of Autologous Bone Marrow-derived Mononuclear Cell Transplantation In-patient With Neurological Sequelae Due to Encephalitis or Meningitis at Vinmec International Hospital

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Sep 6, 2019
Registry last updated
Jun 6, 2024

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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