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Completed

NCT Number: NCT01639404

Umbilical Cord Blood Therapy for Children With Cerebral Palsy

This study aims to evaluate the efficacy of umbilical cord blood therapy for children with cerebral palsy.

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Key information

Age range

6 month–20 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

Cerebral palsy is a disorder of movement and posture resulted from a non-progressive lesion or injury of the immature brain. It is a leading cause of childhood onset disability.

Many experimental animal studies have revealed that umbilical cord blood is useful to repair neurological injury in brain.

On the basis of many experimental studies, umbilical cord blood is suggested as a potential therapy for cerebral palsy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Cerebral Palsy with abnormal muscle tone
  • Gross Motor Function Classification System (GMFCS): I, II, III, IV, V
  • Willing to comply with all study procedure

Exclusion criteria

  • Medical illnesses including pneumonia or renal function at enrollment
  • Presence of known genetic disease
  • Presence of drug hypersensitivity which is related to this study remedy
  • Poor cooperation of guardian,including inactive attitude for rehabilitation and visits for follow-up
  • Decision by the principal investigator when there are unexpected events that may affect the outcomes

Treatment and study plan

Umbilical Cord Blood Administration

Procedure

The subjects will be undertaken allogeneic umbilical cord blood infusion intravenously or intraarterially under non-myeloablative immunosuppression.

Other names: Donated Umbilical Cord Blood Units from Affiliated Cord Blood Bank

Active Rehabilitation

Other

All subjects should participate in active rehabilitation. They will receive two physical and occupational therapy sessions per day. Post discharge, each participant should continue to receive rehabilitation therapy at least 3 days per week until the study completion.

Primary outcomes

  1. Changes in Motor Performance

    Time frame: Baseline - 1 month - 3 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). GMPM scores at each assessment time points will be reported.

  2. Changes in Standardized Gross Motor Function

    Time frame: Baseline - 1 month - 3 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). GMFM scores at each assessment time points will be reported.

Secondary outcomes

  1. Changes in Cognitive Neurodevelopmental Outcome

    Time frame: Baseline - 1 month - 3 months

    Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Mental Scales (higher value means better mental function: 0 - worst, 178 - best). K-BSID-II Mental Scale raw scores at each assessment time points will be reported.

  2. Changes in Motor Neurodevelopmental Outcome

    Time frame: Baseline - 1 month - 3 months

    Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Motor Scales (higher value means better motor function: 0 - worst, 112 - best). K-BSID-II Motor Scale raw scores at each assessment time points will be reported.

  3. Changes in Functional Independence in Daily Activities

    Time frame: Baseline - 1 month - 3 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. Total WeeFIM scores measured at each assessment time points will be reported.

  4. Changes in Visual Perception Test

    Time frame: Baseline - 1 month - 3 months

    Visual perception function will be evaluated with one of three measures: DTVP (Developmental Test of Visual Perception), MVPT (Motor-free Visual Perception Test), and VMI (Visual-Motor Integration, Visual Perception and Motor Coordination). All can be scored as percentile rank from 0 to 100. Higher values mean better visual perception ability.

  5. Changes in Muscle Strength

    Time frame: Baseline - 1 month - 3 months

    Summation of MMT (manual muscle strength test score): 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. Categories of outcome table will be summation of MMT scores measured at each assessment time point.

  6. Changes in Functional Performance in Daily Activities

    Time frame: Baseline - 1 month - 3 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). We will report 2 scales and 3 domains of each scale: a Functional Skill Scale (FSS) and a Caregiver Assistance Scale (CAS) which are divided respectively into 3 domains: self care, mobility, and social function. Categories of outcome table will be each domain scores measured at each assessment time point.

Sponsors and collaborators

Lead sponsor

MinYoung Kim, M.D.

Other

Registry information

Official study title

Allogeneic Umbilical Cord Blood Therapy for Children With Cerebral Palsy

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 12, 2012
Registry last updated
Aug 12, 2013

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.

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