Skip to main content
OpenTrials
Completed

NCT Number: NCT01769716

Umbilical Cord Blood Therapy for 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Global Developmental Delay Communication Disorders Learning Disabilities Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 month–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHA Bundang Medical Center, CHA University

Seongnam-si, Gyeonggi-do, 463-712, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

umbilical cord blood transplantation

Procedure

Other names: Autologous or Allogeneic Umbilical Cord Blood

Primary outcomes

  1. 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)

  2. 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.)

Secondary outcomes

  1. 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.)

  2. 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.)

  3. 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)

  4. 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.

  5. 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.

  6. 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.

  7. 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.)

  8. 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)

  9. Changes in Brain glucose metabolism

    Time frame: Baseline - 12 months

    FDG-PET

Sponsors and collaborators

Lead sponsor

MinYoung Kim, M.D.

Other

Collaborators

  • CHA University

Registry information

Official study title

Umbilical Cord Blood Therapy for Children With Global Developmental Delay

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jan 17, 2013
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.