Umbilical Cord Blood Therapy for Cerebral Palsy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MinYoung Kim, M.D., Bundang CHA Hospital
ClinicalTrials.gov Identifier:
NCT01528436
First received: February 3, 2012
Last updated: July 17, 2012
Last verified: July 2012

February 3, 2012
July 17, 2012
February 2012
July 2012   (final data collection date for primary outcome measure)
  • Changes in Motor Performance [ Time Frame: Baseline - 1 month - 3 months ] [ Designated as safety issue: No ]
    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.
  • Changes in Standardized Gross Motor Function [ Time Frame: Baseline - 1 month - 3 months ] [ Designated as safety issue: No ]
    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.
Same as current
Complete list of historical versions of study NCT01528436 on ClinicalTrials.gov Archive Site
  • Changes in Cognitive Neurodevelopmental Outcome [ Time Frame: Baseline - 1 month - 3 months ] [ Designated as safety issue: No ]
    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.
  • Changes in Motor Neurodevelopmental Outcome [ Time Frame: Baseline - 1 month - 3 months ] [ Designated as safety issue: No ]
    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.
  • Changes in Functional Independence in Daily Activities [ Time Frame: Baseline - 1 month - 3 months ] [ Designated as safety issue: No ]
    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.
  • Changes in Visual Perception Test [ Time Frame: Baseline - 1 month - 3 months ] [ Designated as safety issue: No ]
    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.
  • Changes in Muscle Strength [ Time Frame: Baseline - 1 month - 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET [ Time Frame: Baseline - 2 weeks ] [ Designated as safety issue: No ]
    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.
  • Changes in Cognitive Neurodevelopmental Outcome [ Time Frame: Baseline - 1 month - 3 months ] [ Designated as safety issue: No ]
    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.
  • Changes in Motor Neurodevelopmental Outcome [ Time Frame: Baseline - 1 month - 3 months ] [ Designated as safety issue: No ]
    Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Motor Scales (higher value means better motor function: 0 - worst, 111 - best). We will report K-BSID-II Motor Scale raw scores at each assessment time points.
  • Changes in Functional Independence in Daily Activities [ Time Frame: Baseline - 1 month - 3 months ] [ Designated as safety issue: No ]
    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.
  • Changes in Visual Perception Test [ Time Frame: Baseline - 1 month - 3 months ] [ Designated as safety issue: No ]
    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.
  • Changes in Muscle Strength [ Time Frame: Baseline - 1 month - 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET [ Time Frame: Baseline - 2 weeks ] [ Designated as safety issue: No ]
    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.
Not Provided
Not Provided
 
Umbilical Cord Blood Therapy for Cerebral Palsy
Umbilical Cord Blood Therapy for Cerebral Palsy: a Randomized,Double-blind, Placebo-controlled Trial

This randomized controlled study aims to evaluate the efficacy of umbilical cord blood therapy for children with cerebral palsy.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cerebral Palsy
  • Biological: Umbilical Cord Blood Infusion
    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 Bank
  • Other: Placebo Umbilical Cord Blood
    Placebo Umbilical Cord Blood that resembles cord blood in appearance was designed.
  • Other: 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.
  • Experimental: Umbilical Cord Blood and Rehabilitation
    Allogeneic Umbilical Cord Blood infusion and Active Rehabilitation
    Interventions:
    • Biological: Umbilical Cord Blood Infusion
    • Other: Active Rehabilitation
  • Active Comparator: Placebo Umbilical Cord Blood and Rehabilitation
    Placebo Umbilical Cord Blood infusion and Active Rehabilitation
    Interventions:
    • Other: Placebo Umbilical Cord Blood
    • Other: Active Rehabilitation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
6 Months to 20 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01528436
CPUCBRCT
No
MinYoung Kim, M.D., Bundang CHA Hospital
MinYoung Kim, M.D.
Not Provided
Principal Investigator: Minyoung Kim, M.D., Ph.D. CHA Bundang Medical center, CHA university
Bundang CHA Hospital
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP