- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01639404
Umbilical Cord Blood Therapy for Children With Cerebral Palsy
Allogeneic Umbilical Cord Blood Therapy for Children With Cerebral Palsy
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Gyeonggi-do
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Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712
- CHA Bundang Medical Center, CHA University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Umbilical Cord Blood and Rehabilitation
Allogeneic Umbilical Cord Blood Administration and Active Rehabilitation
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The subjects will be undertaken allogeneic umbilical cord blood infusion intravenously or intraarterially under non-myeloablative immunosuppression.
Other Names:
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Motor Performance
Time Frame: Baseline - 1 month - 3 months
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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.
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Baseline - 1 month - 3 months
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Changes in Standardized Gross Motor Function
Time Frame: Baseline - 1 month - 3 months
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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.
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Baseline - 1 month - 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Cognitive Neurodevelopmental Outcome
Time Frame: Baseline - 1 month - 3 months
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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.
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Baseline - 1 month - 3 months
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Changes in Motor Neurodevelopmental Outcome
Time Frame: Baseline - 1 month - 3 months
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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.
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Baseline - 1 month - 3 months
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Changes in Functional Independence in Daily Activities
Time Frame: Baseline - 1 month - 3 months
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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.
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Baseline - 1 month - 3 months
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Changes in Visual Perception Test
Time Frame: Baseline - 1 month - 3 months
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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.
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Baseline - 1 month - 3 months
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Changes in Muscle Strength
Time Frame: Baseline - 1 month - 3 months
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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.
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Baseline - 1 month - 3 months
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Changes in Functional Performance in Daily Activities
Time Frame: Baseline - 1 month - 3 months
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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.
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Baseline - 1 month - 3 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPUCB
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cerebral Palsy
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Gazi UniversityCompletedCerebral Palsy | Cerebral Palsy, Spastic | Cerebral Palsy Spastic Diplegia | Cerebral Palsy Quadriplegic | Cerebral Palsy, MonoplegicTurkey
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Northwestern UniversityActive, not recruitingCerebral Palsy | Diplegic Cerebral Palsy | Bilateral Cerebral PalsyUnited States
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Centre Médico-Chirurgical de Réadaptation des Massues...RecruitingCerebral Palsy, Dyskinetic | Cerebral Palsy, Spastic | Infantile Hemiplegic Cerebral PalsyFrance
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St Mary's University CollegeUniversity of GloucestershireUnknownCerebral Palsy | Cerebral Palsy Ataxic | Cerebral Palsy, MixedUnited Kingdom
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Hilde FeysHasselt University; ETH Zurich; Curtin UniversityRecruitingHemiplegic Cerebral Palsy | Cerebral Palsy, SpasticBelgium
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University of California, San FranciscoNational Institutes of Health (NIH)RecruitingDystonic Cerebral Palsy | Dyskinetic Cerebral PalsyUnited States
-
MTI UniversityEnrolling by invitationSpastic Diplegic Cerebral PalsyEgypt
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East Carolina UniversityRecruitingHemiplegic Cerebral Palsy | Unilateral Cerebral Palsy | Remote Ischemic ConditioningUnited States
-
October 6 UniversityCompletedSpastic Cerebral Palsy | Spastic Hemiplegic Cerebral PalsyEgypt
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Marmara UniversityUnknownCerebral Palsy, Spastic | Cerebral Palsy, Spastic, DiplegicTurkey
Clinical Trials on Umbilical Cord Blood Administration
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MinYoung Kim, M.D.CompletedGlobal Developmental DelayKorea, Republic of
-
Hospital Clinic of BarcelonaUnknown
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Bundang CHA HospitalWithdrawn
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Bundang CHA HospitalWithdrawnCerebral PalsyKorea, Republic of
-
MinYoung Kim, M.D.Completed
-
MinYoung Kim, M.D.CHA UniversityCompletedGlobal Developmental DelayKorea, Republic of
-
Guangdong Women and Children HospitalUnknownSafety Issues | Effect of DrugsChina
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Guangdong Women and Children HospitalRecruitingSafety Issues;Effect of DrugsChina
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New York Blood CenterTerminatedLymphoma | Leukemia | Myelodysplasia | Genetic Disease | Severe Aplastic AnemiaUnited States