Encephalitis, Meningitis
Conditions
Keywords
encephalitis, meningitis, neurological sequelae due
Brief summary
To evaluate the safety and efficacy of autologous bone marrow-derived mononuclear cell transplantation in-patient with neurological sequelae due to encephalitis or meningitis
Detailed description
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
Interventions
COMBINATION_PRODUCTStem cell transplantation
Transplantation of Autologous Bone Marrow Mononuclear Cells
Sponsors
Vinmec Research Institute of Stem Cell and Gene Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Score of Gross Motor Function Measure (GMFM-88) | 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 |
| Change in Muscle Tone Assessed by Modified Ashworth Scale (MAS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events | Through study completion, an average of 12 months | Examples of adverse events to look for: fever, infections, vomit, epilepsy |
Countries
Vietnam
Outcome results
None listed