Umbilical Cord Blood Therapy for Global Developmental Delay

Global Developmental Delay Clinical Trial

Official title:

Umbilical Cord Blood Therapy for Children With Global Developmental Delay

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01769716
• Other study ID #: UCBGDD
• Status: Completed
• Phase: N/A
• First received: January 15, 2013
• Last updated: January 22, 2018
• Start date: December 2012
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: Bundang CHA Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Global Developmental Delay

Intervention

Procedure:
• Umbilical cord blood transplantation

Locations

Country	Name	City	State
Korea, Republic of	CHA Bundang Medical Center, CHA University	Seongnam-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
MinYoung Kim, M.D.	CHA University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Baseline - 6 months - 12 months
Primary	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.)	Baseline - 1 month - 3 months - 6 months - 12 months
Secondary	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.)	Baseline - 1 month - 3 months - 6 months - 12 months
Secondary	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.)	Baseline - 1 month - 3 months - 6 months - 12 months
Secondary	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)	Baseline - 1 month - 3 months - 6 months - 12 months
Secondary	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.	Baseline - 1 month - 3 months - 6 months - 12 months
Secondary	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.	Baseline - 1 month - 3 months - 6 months - 12 months
Secondary	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.	Baseline - 1 month - 3 months - 6 months - 12 months
Secondary	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.)	Baseline - 1 month - 3 months - 6 months - 12 months
Secondary	Changes in Language Evaluation	Sequenced Language Scale for Infant (SELSI), Preschool Receptive-Expressive Language Scale (PRES) or Korean Western Aphasia Battery (K-WAB)	Baseline - 6 months - 12 months
Secondary	Changes in Brain glucose metabolism	FDG-PET	Baseline - 12 months