The Outcomes of Autologous Bone Marrow-derived Mononuclear Cell Transplantation In-patient With Neurological Sequelae Due to Encephalitis or Meningitis at Vinmec International Hospital
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Encephalitis
- Sponsor
- Vinmec Research Institute of Stem Cell and Gene Technology
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Change in Muscle Tone Assessed by Modified Ashworth Scale (MAS)
- Status
- Completed
- Last Updated
- last year
Overview
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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
- Number of adverse events(Through study completion, an average of 12 months)