An interventional study of Umbilical cord blood transplantation in Global Developmental Delay, sponsored by MinYoung Kim, M.D.. Completed at 1 site in Korea, Republic of. Open to participants aged 6 Months to 15 Years. Per ClinicalTrials.gov, last updated 2018-01-23.
Sponsored by MinYoung Kim, M.D. · Not applicable, Interventional, and Treatment
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.
MinYoung Kim, M.D. is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Procedure: Umbilical cord blood transplantation
Also known as: Autologous or Allogeneic Umbilical Cord Blood
Changes in Cognition
Korean Wechsler Preschool and Primary Scale of Intelligence (K-WPPSI) (Higher value means better cognitive function (K-WPPSI: below 70 - worst, over 130 - best)
Time frame: Baseline - 6 months - 12 months
Changes in Cognitive Neurodevelopmental Outcome
Korean version of Bayley Scale of Infant Development-II Mental Scales (Higher value means better cognitive function: raw score 0 - worst, 178 - best.)
Time frame: Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Motor Performance
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.)
Time frame: Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Standardized Gross Motor Function
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.)
Time frame: Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Motor Neurodevelopmental Outcome
Korean version of Bayley Scale of Infant Development-II Motor Scales (Higher value means better motor function: raw score 0 - worst, 112 - best)
Time frame: Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Functional Independence in Daily Activities
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.
Time frame: Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Visual Perception Test
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.
Time frame: Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Muscle Strength
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.
Time frame: Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Functional Performance in Daily Activities
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.)
Time frame: Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Language Evaluation
Sequenced Language Scale for Infant (SELSI), Preschool Receptive-Expressive Language Scale (PRES) or Korean Western Aphasia Battery (K-WAB)
Time frame: Baseline - 6 months - 12 months
Changes in Brain glucose metabolism
FDG-PET
Time frame: Baseline - 12 months
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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MinYoung Kim, M.D.