Umbilical Cord Blood Therapy for Children With Cerebral Palsy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MinYoung Kim, M.D., Bundang CHA Hospital
ClinicalTrials.gov Identifier:
NCT01639404
First received: July 10, 2012
Last updated: August 8, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention
Cerebral Palsy
Procedure: Umbilical Cord Blood Administration
Other: Active Rehabilitation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Allogeneic Umbilical Cord Blood Therapy for Children With Cerebral Palsy

Resource links provided by NLM:


Further study details as provided by Bundang CHA Hospital:

Primary Outcome Measures:
  • Changes in Motor Performance [ Time Frame: Baseline - 1 month - 3 months ] [ Designated as safety issue: No ]
    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.

  • Changes in Standardized Gross Motor Function [ Time Frame: Baseline - 1 month - 3 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Changes in Cognitive Neurodevelopmental Outcome [ Time Frame: Baseline - 1 month - 3 months ] [ Designated as safety issue: No ]
    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.

  • Changes in Motor Neurodevelopmental Outcome [ Time Frame: Baseline - 1 month - 3 months ] [ Designated as safety issue: No ]
    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.

  • Changes in Functional Independence in Daily Activities [ Time Frame: Baseline - 1 month - 3 months ] [ Designated as safety issue: No ]
    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.

  • Changes in Visual Perception Test [ Time Frame: Baseline - 1 month - 3 months ] [ Designated as safety issue: No ]
    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.

  • Changes in Muscle Strength [ Time Frame: Baseline - 1 month - 3 months ] [ Designated as safety issue: No ]
    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.

  • Changes in Functional Performance in Daily Activities [ Time Frame: Baseline - 1 month - 3 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 17
Study Start Date: July 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Umbilical Cord Blood and Rehabilitation
Allogeneic Umbilical Cord Blood Administration and Active Rehabilitation
Procedure: Umbilical Cord Blood Administration
The subjects will be undertaken allogeneic umbilical cord blood infusion intravenously or intraarterially under non-myeloablative immunosuppression.
Other Name: Donated Umbilical Cord Blood Units from Affiliated Cord Blood Bank
Other: Active Rehabilitation
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   6 Months to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01639404

Locations
Korea, Republic of
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712
Sponsors and Collaborators
MinYoung Kim, M.D.
Investigators
Principal Investigator: MinYoung Kim, M.D., Ph.D. CHA University
  More Information

No publications provided

Responsible Party: MinYoung Kim, M.D., Associate Professor, Bundang CHA Hospital
ClinicalTrials.gov Identifier: NCT01639404     History of Changes
Other Study ID Numbers: CPUCB
Study First Received: July 10, 2012
Last Updated: August 8, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Bundang CHA Hospital:
Cerebral Palsy
Umbilical Cord Blood
Rehabilitation

Additional relevant MeSH terms:
Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2014