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Umbilical Cord Blood Therapy for Global Developmental Delay

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ClinicalTrials.gov Identifier: NCT01769716
Recruitment Status : Completed
First Posted : January 17, 2013
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
CHA University
Information provided by (Responsible Party):
MinYoung Kim, M.D., Bundang CHA Hospital

January 15, 2013
January 17, 2013
January 23, 2018
December 2012
December 2017   (Final data collection date for primary outcome measure)
  • Changes in Cognition [ Time Frame: Baseline - 6 months - 12 months ]
    Korean Wechsler Preschool and Primary Scale of Intelligence (K-WPPSI) (Higher value means better cognitive function (K-WPPSI: below 70 - worst, over 130 - best)
  • 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 Mental Scales (Higher value means better cognitive function: raw score 0 - worst, 178 - best.)
Same as current
Complete list of historical versions of study NCT01769716 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.)
  • 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.)
  • 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 Motor Scales (Higher value means better motor function: raw score 0 - worst, 112 - best)
  • 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.
  • Changes in Visual Perception Test [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ]
    Visual perception function is evaluated with one of three measures: DTVP (Developmental Test of Visual Perception), MVPT (Motor-free Visual Perception Test), and VMI (Visual-Motor Integration). 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 testing): 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.
  • 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.)
  • 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)
  • Changes in Brain glucose metabolism [ Time Frame: Baseline - 12 months ]
    FDG-PET
Same as current
Not Provided
Not Provided
 
Umbilical Cord Blood Therapy for Global Developmental Delay
Umbilical Cord Blood Therapy for Children With Global Developmental Delay
This open-label study aims to evaluate the safety and efficacy of autologous or allogeneic umbilical cord blood therapy for children with global developmental delay.

Global developmental delay is 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
Intervention Model Description:
allogeneic cord blood transplantation for children with developmental delay
Masking: None (Open Label)
Primary Purpose: Treatment
Global Developmental Delay
Procedure: Umbilical cord blood transplantation
Other Name: Autologous or Allogeneic Umbilical Cord Blood
Experimental: Umbilical cord blood transplantation
Allogeneic umbilical cord blood will be administered intravenously or intraarterially under non-myeloablative immunosuppression. In case of autologous umbilical cord blood, immunosuppression is not required.
Intervention: Procedure: Umbilical cord blood transplantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
10
December 2017
December 2017   (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
 
 
NCT01769716
UCBGDD
No
Not Provided
Not Provided
MinYoung Kim, M.D., Bundang CHA Hospital
MinYoung Kim, M.D.
CHA University
Principal Investigator: MinYoung Kim, M.D., Ph.D. CHA University
Bundang CHA Hospital
January 2018

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