Umbilical Cord Blood Therapy for Global Developmental Delay
Recruitment status was: Recruiting
|Global Developmental Delay||Procedure: Umbilical Cord Blood administration||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Umbilical Cord Blood Therapy for Children With Global Developmental Delay|
- 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.)
- 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
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Umbilical cord blood therapy
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 administration
Other Name: Autologous or Allogeneic Umbilical Cord Blood
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01769716
|Contact: MinYoung Kim, M.D., Ph.D.||firstname.lastname@example.org|
|Contact: Kyunghoon Min, M.D.||email@example.com|
|Korea, Republic of|
|CHA Bundang Medical Center, CHA University||Recruiting|
|Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712|
|Contact: MinYoung Kim, M.D., Ph.D. 82-31-780-6281 firstname.lastname@example.org|
|Contact: Kyunghoon Min, M.D. 82-31-780-6281 email@example.com|
|Principal Investigator: MinYoung Kim, M.D., Ph.D.|
|Sub-Investigator: Myung Seo Kang, M.D., Ph.D.|
|Sub-Investigator: Sang Heum Kim, M.D.|
|Sub-Investigator: Su Jin Jang, M.D.|
|Sub-Investigator: Kyunghoon Min, M.D.|
|Sub-Investigator: Su Jin Yoo, M.D.|
|Principal Investigator:||MinYoung Kim, M.D., Ph.D.||CHA University|