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Umbilical Cord Blood Therapy for Children With Global Developmental Delay

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ClinicalTrials.gov Identifier: NCT01601158
Recruitment Status : Completed
First Posted : May 17, 2012
Last Update Posted : January 9, 2014
Sponsor:
Information provided by (Responsible Party):
MinYoung Kim, M.D., Bundang CHA Hospital

May 16, 2012
May 17, 2012
January 9, 2014
May 2012
August 2013   (Final data collection date for primary outcome measure)
  • Changes in Cognition [ Time Frame: Baseline - 6 months - 12 months ]
    Korean Wechsler Preschool and Primay Scale of Intelligence (K-WPPSI) (Higher value means better cognitive function (K-WPPSI: below 70 - worst, over 130 - best). The investigators will report K-WPPSI at each assessment time points.
  • Changes in Cognitive Neurodevelopmental Outcome [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ]
    Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Mental Scales (Higher value means better cognitive function, K-BSID-II mental scale raw score: 0 - worst, 178 - best). The investigators will report K-BSID-II Mental Scale raw scores at each assessment time points.
  • Changes in Cognition [ Time Frame: Baseline - 6 months - 12 months ]
    Korean Wechsler Preschool and Primay Scale of Intelligence (K-WPPSI) (Higher value means better cognitive function (K-WPPSI: below 70 - worst, over 130 - best). We will report K-WPPSI at each assessment time points.
  • Changes in Cognitive Neurodevelopmental Outcome [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ]
    Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Mental Scales (Higher value means better cognitive function, K-BSID-II mental scale raw score: 0 - worst, 178 - best). We will report K-BSID-II Mental Scale raw scores at each assessment time points.
Complete list of historical versions of study NCT01601158 on ClinicalTrials.gov Archive Site
  • Changes in Motor Performance [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 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). The investigators will report GMPM scores at each assessment time points.
  • Changes in Standardized Gross Motor Function [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 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). The investigators will report GMFM scores at each assessment time points.
  • Changes in Motor Neurodevelopmental Outcome [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ]
    Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Motor Scales (higher value means better motor function: 0 - worst, 111 - best). The investigators 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 - 6 months - 12 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. The investigators will report total WeeFIM scores measured at each assessment time points.
  • Changes in Visual Perception Test [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ]
    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 - 6 months - 12 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 - 6 months - 12 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.
  • Changes in Language Evaluation [ Time Frame: Baseline - 6 months - 12 months ]
    Sequenced Language Scale for Infant (SELSI), Preschool Receptive-Expressive Language Scale (PRES) or Korean Western Aphasia Battery (K-WAB) will be used depending on age and function.
  • Changes in Motor Performance [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 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.
  • Changes in Standardized Gross Motor Function [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 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). We will report GMFM scores at each assessment time points.
  • Changes in Motor Neurodevelopmental Outcome [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ]
    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 - 6 months - 12 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. We will report total WeeFIM scores measured at each assessment time points.
  • Changes in Visual Perception Test [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ]
    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 - 6 months - 12 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 - 6 months - 12 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.
  • Changes in Language Evaluation [ Time Frame: Baseline - 6 months - 12 months ]
    Sequenced Language Scale for Infant (SELSI), Preschool Receptive-Expressive Language Scale (PRES) or Korean Western Aphasia Battery (K-WAB) will be used depending on age and function.
Not Provided
Not Provided
 
Umbilical Cord Blood Therapy for Children With Global Developmental Delay
Safety and Efficacy of Allogeneic Umbilical Cord Blood Therapy for Children With Global Developmental Delay
This open-label study aims to evaluate the safety and efficacy of umbilical cord blood therapy for children with global developmental delay.

Global developmental delay (GDD) is a subset of developmental disabilities defined as significant delay in two or more of the following developmental domains: gross/fine motor, speech/language, cognition, social/personal, and activities of daily living.

Umbilical cord blood has been used for inherited metabolic diseases that feature global developmental delay and many experimental animal studies have revealed umbilical cord blood is useful to repair neurological impairments in brain.

Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Global Developmental Delay
  • Biological: 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 Bank
  • 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 administration
  • 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
10
Same as current
August 2013
August 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Global developmental delay
  • Willing to comply with all study procedure

Exclusion Criteria:

  • Medical instability including pneumonia or renal function at enrollment
  • Poor cooperation of guardian,including inactive attitude for rehabilitation and visits for follow-up
  • Uncontrolled persistent epilepsy
  • Not eligible according to the principal investigator
Sexes Eligible for Study: All
6 Months to 15 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01601158
GDDUCB
No
Not Provided
Not Provided
MinYoung Kim, M.D., Bundang CHA Hospital
MinYoung Kim, M.D.
Not Provided
Principal Investigator: Minyoung Kim, M.D., Ph.D. CHA University
Bundang CHA Hospital
January 2014

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