This open label trial is conducted to investigate the efficacy and safety of the combination therapy of allogeneic umbilical cord blood (UCB) and granulocyte-colony stimulating factor (G-CSF) for patients with brain injury or neurodegenerative disorders.
Current treatments for brain injury or neurodegenerative disorders are palliative rather than curative. Preclinical and some clinical studies suggest that UCB and G-CSF can be used as restorative approach for such disorders.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, South Korea
Changes in Berg Balance Scale
Berg Balance Scale for brain injury and parkinson's disease (range: 0 to 56, Higher scores indicates better balance function.)
Time frame: Baseline - 1 month - 3 months - 6 months
Changes in the Level of Disability
FIM (Functional Independence Measure) for brain injury and cerebral palsy (range: 18 to 126, Higher scores indicate more independence in activities of daily living.)
Time frame: Baseline - 1 month - 3 months - 6 months
Changes in Standardized Gross Motor Function
GMFM (Gross Motor Function Measure) for cerebral palsy (range: 0 to 100, Higher scores indicate better gross motor function.)
Time frame: Baseline - 1 month - 3 months - 6 months
Changes in Motor Performance
GMPM (Gross Motor Performance Measure) for cerebral palsy (range: 0 to 100, Higher scores indicate better motor quality.)
Time frame: Baseline - 1 month - 3 months - 6 months
Changes in ALSFRS-R
ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-revised) for ALS (range: 0 to 48, Higher scores indicate better physical function.)
Time frame: Baseline - 1 month - 3 months - 6 months
Changes in UPDRS
UPDRS (Unified Parkinson's Disease Rating Scale) for parkinson's disease (Part 1: mentation, behavior and mood; Part 2: activities of daily living; Part 3: motor examination; Part 4: complications of therapy; Part 5: Schwab and England activities of daily living scale)
Time frame: Baseline - 1 month - 3 months - 6 months
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Changes in Brain MRI
Analysis of Diffusion Tensor Image (DTI) for brain injury, cerebral palsy, ALS
Time frame: Baseline - 6 months
Changes in Brain PET
for parkinson's disease
Time frame: Baseline - 6 months
Number of adverse events and participants with those adverse events
The numbers of adverse events and subjects with those serious adverse events within each group; A serious adverse event is any untoward medical occurrence that at any dose: results in death or is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or causes a congenital anomaly/birth defect.
Time frame: 6 months