Umbilical Cord Blood Therapy for Children With Cerebral Palsy
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|ClinicalTrials.gov Identifier: NCT01639404|
Recruitment Status : Completed
First Posted : July 12, 2012
Last Update Posted : August 12, 2013
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy||Procedure: Umbilical Cord Blood Administration Other: Active Rehabilitation||Not Applicable|
Cerebral palsy is a disorder of movement and posture resulted from a non-progressive lesion or injury of the immature brain. It is a leading cause of childhood onset disability.
Many experimental animal studies have revealed that umbilical cord blood is useful to repair neurological injury in brain.
On the basis of many experimental studies, umbilical cord blood is suggested as a potential therapy for cerebral palsy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Allogeneic Umbilical Cord Blood Therapy for Children With Cerebral Palsy|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
Experimental: Umbilical Cord Blood and Rehabilitation
Allogeneic Umbilical Cord Blood Administration and Active Rehabilitation
Procedure: Umbilical Cord Blood Administration
The subjects will be undertaken allogeneic umbilical cord blood infusion intravenously or intraarterially under non-myeloablative immunosuppression.
Other Name: Donated Umbilical Cord Blood Units from Affiliated Cord Blood BankOther: Active Rehabilitation
All subjects should participate in active rehabilitation. They will receive two physical and occupational therapy sessions per day. Post discharge, each participant should continue to receive rehabilitation therapy at least 3 days per week until the study completion.
- Changes in Motor Performance [ Time Frame: Baseline - 1 month - 3 months ]GMPM (Gross Motor Performance Measure) as 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). GMPM scores at each assessment time points will be reported.
- Changes in Standardized Gross Motor Function [ Time Frame: Baseline - 1 month - 3 months ]GMFM (Gross Motor Function Measure) as 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). GMFM scores at each assessment time points will be reported.
- Changes in Cognitive Neurodevelopmental Outcome [ Time Frame: Baseline - 1 month - 3 months ]Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Mental Scales (higher value means better mental function: 0 - worst, 178 - best). K-BSID-II Mental Scale raw scores at each assessment time points will be reported.
- Changes in Motor Neurodevelopmental Outcome [ Time Frame: Baseline - 1 month - 3 months ]Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Motor Scales (higher value means better motor function: 0 - worst, 112 - best). K-BSID-II Motor Scale raw scores at each assessment time points will be reported.
- Changes in Functional Independence in Daily Activities [ Time Frame: Baseline - 1 month - 3 months ]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 scores mean more independent performance in daily activities. Total WeeFIM scores measured at each assessment time points will be reported.
- Changes in Visual Perception Test [ Time Frame: Baseline - 1 month - 3 months ]Visual perception function will be evaluated with one of three measures: DTVP (Developmental Test of Visual Perception), MVPT (Motor-free Visual Perception Test), and VMI (Visual-Motor Integration, Visual Perception and Motor Coordination). All can be scored as percentile rank from 0 to 100. Higher values mean better visual perception ability.
- Changes in Muscle Strength [ Time Frame: Baseline - 1 month - 3 months ]Summation of MMT (manual muscle strength test score): summated scores of the manual muscle strength 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 scores mean better muscle strength. Categories of outcome table will be summation of MMT scores measured at each assessment time point.
- Changes in Functional Performance in Daily Activities [ Time Frame: Baseline - 1 month - 3 months ]Pediatric Evaluation of Disability Inventory (PEDI) for assessing functional performance in daily activities in children (All values are adjusted and higher value means better functional performance, 0 - worst, 100 - best). We will report 2 scales and 3 domains of each scale: a Functional Skill Scale (FSS) and a Caregiver Assistance Scale (CAS) which are divided respectively into 3 domains: self care, mobility, and social function. Categories of outcome table will be each domain scores measured at each assessment time point.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01639404
|Korea, Republic of|
|CHA Bundang Medical Center, CHA University|
|Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712|
|Principal Investigator:||MinYoung Kim, M.D., Ph.D.||CHA University|