This open-label study aims to analyze cytokines related to clinical outcomes of allogeneic umbilical cord blood therapy for children with cerebral palsy.
Cerebral palsy (CP) is a group of neurodevelopmental conditions with abnormal movement and posture resulted from a non-progressive cerebral disturbance. It is the most common cause of motor disability in childhood. Most therapies are palliative rather than restorative. Umbilical cord blood (UCB) may be used as restorative approach for children with CP. Many experimental animal studies have revealed that UCB is beneficial to improve and repair neurological injuries. Based on animal studies and some clinical trials, UCB is suggested as a potential therapy for children with CP. This study was designed to find cytokines relevant to UCB therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, South Korea
Cytokine analysis
Cytokine analysis
Time frame: 12 months
Changes in Standardized Gross Motor Function
GMFM (Gross Motor Function Measure) is a standardized measurement tool for assessing gross motor function consisting of sub-scales; lying \& rolling, sitting, crawling \& kneeling, standing, walking, running \& jumping (range: 0\~100, higher value means better gross motor function).
Time frame: Baseline - 3 months - 6 months - 12months
Changes in Motor Performance
GMPM (Gross Motor Performance Measure) is a standardized measurement tool for assessing quality of movement regarding 3 properties of 5 ones; alignment, coordination, dissociated movement, stability, and weight shift (range: 0\~100, higher value means better motor quality).
Time frame: Baseline - 3 months - 6 months - 12 months
Changes in Cognitive Neurodevelopmental Outcome
Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Mental Scale (range: 0\~178; worst: 0, best: 178)
Time frame: Baseline - 3 months - 6 months - 12 months
Changes in Motor Neurodevelopmental Outcome
Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Motor Scale (range: 0\~112; worst: 0, best: 112)
Time frame: Baseline - 3 months - 6 months - 12 months
Changes in Gross Motor Function Classification System
GMFCS (Gross Motor Function Classification System) is a five-level classification system based on self-initiated movement, with emphasis on sitting, transfers, and mobility (level I: walks without limitations, ll: walks with limitations, III: walks using a hand-held mobility device, IV: self-mobility with limitations, V: transported in a manual wheelchair).
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Time frame: Baseline - 3 months - 6 months - 12 months
Changes in Functional Independence in Daily Activities
WeeFIM (Functional Independence Measure for Children) measures functional independence in daily activities. WeeFIM contains 18 items and each item is ranked from complete dependence (scored as 1) to complete independence (scored as 7). The range is from 18 to 126 and higher score means more independent performance in daily activities.
Time frame: Baseline - 3 months - 6 months - 12 months
Changes in Functional Performance in Daily Activities
Pediatric Evaluation of Disability Inventory (PEDI) is used to assess functional performance in daily activities in children (All values are adjusted and higher value means better functional performance, 0 - worst, 100 - best). PEDI consists of 2 scales such as Functional Skill Scale (FSS) and a Caregiver Assistance Scale (CAS) and each scale is composed of 3 domains including self care, mobility, and social function.
Time frame: Baseline - 3 months - 6 months - 12 months
Changes in Upper Extremity Function
QUEST (Quality of Upper Extremity Skills Test) is a standardized measurement tool for assessing upper extremity function consisting of sub-scales; dissociated movement, grasps, weight bearing, and protective extension. QUEST ranges from 0 (or below 0 in grasp section) to 100 and higher values mean better upper extremity function.
Time frame: Baseline - 3 months - 6 months - 12 months
Changes in Visual Perception Test
Visual perception function will be assessed with one of 3 tools such as DTVP (Developmental Test of Visual Perception), MVPT (Motor-free Visual Perception Test), and VMI (Visual-Motor Integration, Visual Perception and Motor Coordination). Higher value means better visual perception ability.
Time frame: Baseline - 3 months - 6 months - 12 months
Changes in Selective Movement of Lower Extremity
SCALE (Selective Control Assessment of Lower Extremity) is a measurement tool of selective movement of hip, knee, ankle, subtalar joint and toes. Selective voluntary motor control is graded at each joint as normal (2 points), impaired (1 point) or unable (0 point).
Time frame: Baseline - 3 months - 6 months - 12 months
Changes in Spasticity
Muscle spasticity of biceps, hip adductors, hamstrings and heel cords is graded according to modified Ashworth scale (MAS).
Time frame: Baseline - 3 months - 6 months - 12 months
Changes in Dynamic Component of Spasticity
Dynamic component of spasticity in bilateral hamstrings is graded using modified Tardieu scale (MTS).
Time frame: Baseline - 3 months - 6 months - 12 months
Changes in Muscle Strength
Muscle strength is measured using summated scores of manual muscle test (zero=0, trace=1, poor=2, fair=3, good=4, normal=5) for flexors, extensors, abductors, and adductors of bilateral shoulder and hip joints; flexors and extensors of bilateral elbow, wrist, and knee; dorsiflexors and plantar flexors of the ankles (range: 0 \~ 160). Higher score means stronger muscle power.
Time frame: Baseline - 3 months - 6 months - 12 months
Changes in Brain MRI
Diffusion Tensor Image (DTI) of brain MRI (magnetic resonance imaging) provides quantitative information about the microscopic integrity of white matter. White matter normally possesses a high degree of diffusion anisotropy than gray matter. Fractional anisotropy (FA) will be measured and it ranges from 0 to 1. Higher FA value means more integrity of white matter.
Time frame: Baseline - 12 months
Changes in Brain 18F-FDG PET
18F-FDG PET (Positron emission tomography with fluorine-18-fluorodeoxyglucose) imaging will be performed twice prior to and 12 months after UCB therapy.
Time frame: Baseline - 12 months
Changes in EEG
Electroencephalography (EEG) will be performed twice prior to and 12 months after UCB therapy.
Time frame: Baseline - 12 months
Changes in EP
Median, tibial somatosensory evoked potential (SEP), visual evoked potential (VEP), auditory evoked potential (AEP) will be performed twice prior to and 12 months after UCB therapy.
Time frame: Baseline - 12 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: 12 months