- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01528436
Umbilical Cord Blood Therapy for Cerebral Palsy
Umbilical Cord Blood Therapy for Cerebral Palsy: a Randomized,Double-blind, Placebo-controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Gyeonggi-do
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Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712
- CHA Bundang Medical Center, CHA University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Cerebral Palsy with abnormal muscle tone
- Gross Motor Function Classification System (GMFCS): I, II, III, IV, V
- Willing to comply with all study procedure
Exclusion Criteria:
- Medical instability including pneumonia or renal function at enrollment
- Presence of known genetic disease
- Presence of drug hypersensitivity which is related to this study remedy
- Poor cooperation of guardian,including inactive attitude for rehabilitation and visits for follow-up
- Decision by the principal investigator when there are unexpected events including brain surgery, that may affect the outcome
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Umbilical Cord Blood and Rehabilitation
Allogeneic Umbilical Cord Blood infusion and Active Rehabilitation
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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.
The subjects will be undertaken allogeneic umbilical cord blood infusion intravenously or intraarterially under non-myeloablative immunosuppression.
Other Names:
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Active Comparator: Placebo Umbilical Cord Blood and Rehabilitation
Placebo Umbilical Cord Blood infusion and Active Rehabilitation
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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.
Placebo Umbilical Cord Blood that resembles cord blood in appearance was designed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
We will report GMPM scores at each assessment time points.
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Baseline - 1 month - 3 months
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Changes in Standardized Gross Motor Function
Time Frame: Baseline - 1 month - 3 months
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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).
We will report GMFM scores at each assessment time points.
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Baseline - 1 month - 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Muscle Strength
Time Frame: Baseline - 1 month - 3 months
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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.
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Baseline - 1 month - 3 months
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Changes in Functional Performance in Daily Activities
Time Frame: Baseline - 1 month - 3 months
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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.
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Baseline - 1 month - 3 months
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Changes in Cognitive Neurodevelopmental Outcome
Time Frame: Baseline - 1 month - 3 months
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Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Mental Scales (higher value means better mental function: 0 - worst, 178 - best).
We will report K-BSID-II Mental Scale raw scores at each assessment time points.
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Baseline - 1 month - 3 months
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Changes in Motor Neurodevelopmental Outcome
Time Frame: Baseline - 1 month - 3 months
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Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Motor Scales (higher value means better motor function: 0 - worst, 112 - best).
We will report K-BSID-II Motor Scale raw scores at each assessment time points.
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Baseline - 1 month - 3 months
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Changes in Functional Independence in Daily Activities
Time Frame: Baseline - 1 month - 3 months
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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.
We will report total WeeFIM scores measured at each assessment time points.
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Baseline - 1 month - 3 months
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Changes in Visual Perception Test
Time Frame: Baseline - 1 month - 3 months
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We will evaluate visual perception function 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.
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Baseline - 1 month - 3 months
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Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET
Time Frame: Baseline - 2 weeks
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18F-FDG PET imaging will be underwent twice prior to and then 2 weeks post-treatment.
All scans will be reviewed by a nuclear physician.
Spatial pre-processing and statistical analyses will be done using SPM8 implanted in Matlab to compare differences in regional brain glucose metabolism between groups and differences between pre- and post-therapy imaging data.
We will reported increased areas and decreased areas of glucose metabolism in two groups.
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Baseline - 2 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPUCBRCT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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