- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02025972
Allogeneic Umbilical Cord Blood Therapy in Children With CP
Changes in Cytokines and Functional Outcomes of Allogeneic Cord Blood Therapy in Children With Cerebral Palsy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cerebral palsy (CP) is a group of neurodevelopmental conditions with abnormal movement and posture resulted from a non-progressive cerebral disturbance. It is the most common cause of motor disability in childhood. Most therapies are palliative rather than restorative. Umbilical cord blood (UCB) may be used as restorative approach for children with CP.
Many experimental animal studies have revealed that UCB is beneficial to improve and repair neurological injuries.
Based on animal studies and some clinical trials, UCB is suggested as a potential therapy for children with CP. This study was designed to find cytokines relevant to UCB therapy.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gyeonggi-do
-
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712
- CHA Bundang Medical Center, CHA University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosed with cerebral palsy
- Age of ≤15 years
- Mismatch in HLA-A, B, and DR ≤2, and total nucleated cell count ≥3x10^7/kg. If the cell count is less than given values, more than 1 unit could be used.
- Decision of participation in the study by and acquisition of informed consent from the subject's representative
- Willingness and ability to be hospitalized according to the schedule specified in the protocol and continue the study for 12 months after study entry
Exclusion Criteria:
- Current aspiration pneumonia
- Known genetic disease
- History of hypersensitivity reaction to any study drugs pertinent to the study
- Patient with severe seizure disease who has clinical convulsion despite combination therapy with 3 or more agents
- Uncontrolled hypertension defined as systolic blood pressure >115 mmHg and/or diastolic blood pressure >70 mmHg
- Hepatic impairment defined as asparate aminotransferase (AST) >55 IU/L and/or alanine aminotransferase (ALT) >45 IU/L
- Renal impairment defined as creatinine (Cr) ≥1.2 mg/dL
- Presence of diagnosed or suspected malignant tumor and/or hematologic malignancy
- Non-compliance with study visits specified in the protocol or unwillingness of care-giver due to lack of understanding of the patient
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: Allogeneic umbilical cord blood therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cytokine analysis
Time Frame: 12 months
|
Cytokine analysis
|
12 months
|
Changes in Standardized Gross Motor Function
Time Frame: Baseline - 3 months - 6 months - 12months
|
GMFM (Gross Motor Function Measure) is 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 - 3 months - 6 months - 12months
|
Changes in Motor Performance
Time Frame: Baseline - 3 months - 6 months - 12 months
|
GMPM (Gross Motor Performance Measure) is 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 - 3 months - 6 months - 12 months
|
Changes in Cognitive Neurodevelopmental Outcome
Time Frame: Baseline - 3 months - 6 months - 12 months
|
Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Mental Scale (range: 0~178; worst: 0, best: 178)
|
Baseline - 3 months - 6 months - 12 months
|
Changes in Motor Neurodevelopmental Outcome
Time Frame: Baseline - 3 months - 6 months - 12 months
|
Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Motor Scale (range: 0~112; worst: 0, best: 112)
|
Baseline - 3 months - 6 months - 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Brain MRI
Time Frame: Baseline - 12 months
|
Diffusion Tensor Image (DTI) of brain MRI (magnetic resonance imaging) provides quantitative information about the microscopic integrity of white matter.
White matter normally possesses a high degree of diffusion anisotropy than gray matter.
Fractional anisotropy (FA) will be measured and it ranges from 0 to 1. Higher FA value means more integrity of white matter.
|
Baseline - 12 months
|
Changes in Brain 18F-FDG PET
Time Frame: Baseline - 12 months
|
18F-FDG PET (Positron emission tomography with fluorine-18-fluorodeoxyglucose) imaging will be performed twice prior to and 12 months after UCB therapy.
|
Baseline - 12 months
|
Changes in EEG
Time Frame: Baseline - 12 months
|
Electroencephalography (EEG) will be performed twice prior to and 12 months after UCB therapy.
|
Baseline - 12 months
|
Changes in EP
Time Frame: Baseline - 12 months
|
Median, tibial somatosensory evoked potential (SEP), visual evoked potential (VEP), auditory evoked potential (AEP) will be performed twice prior to and 12 months after UCB therapy.
|
Baseline - 12 months
|
Number of adverse events and participants with those adverse events
Time Frame: 12 months
|
The numbers of adverse events and subjects with those serious adverse events within each group; A serious adverse event is any untoward medical occurrence that at any dose: results in death or is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or causes a congenital anomaly/birth defect.
|
12 months
|
Changes in Gross Motor Function Classification System
Time Frame: Baseline - 3 months - 6 months - 12 months
|
GMFCS (Gross Motor Function Classification System) is a five-level classification system based on self-initiated movement, with emphasis on sitting, transfers, and mobility (level I: walks without limitations, ll: walks with limitations, III: walks using a hand-held mobility device, IV: self-mobility with limitations, V: transported in a manual wheelchair).
|
Baseline - 3 months - 6 months - 12 months
|
Changes in Functional Independence in Daily Activities
Time Frame: Baseline - 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 score means more independent performance in daily activities.
|
Baseline - 3 months - 6 months - 12 months
|
Changes in Functional Performance in Daily Activities
Time Frame: Baseline - 3 months - 6 months - 12 months
|
Pediatric Evaluation of Disability Inventory (PEDI) is used to assess functional performance in daily activities in children (All values are adjusted and higher value means better functional performance, 0 - worst, 100 - best).
PEDI consists of 2 scales such as Functional Skill Scale (FSS) and a Caregiver Assistance Scale (CAS) and each scale is composed of 3 domains including self care, mobility, and social function.
|
Baseline - 3 months - 6 months - 12 months
|
Changes in Upper Extremity Function
Time Frame: Baseline - 3 months - 6 months - 12 months
|
QUEST (Quality of Upper Extremity Skills Test) is a standardized measurement tool for assessing upper extremity function consisting of sub-scales; dissociated movement, grasps, weight bearing, and protective extension.
QUEST ranges from 0 (or below 0 in grasp section) to 100 and higher values mean better upper extremity function.
|
Baseline - 3 months - 6 months - 12 months
|
Changes in Visual Perception Test
Time Frame: Baseline - 3 months - 6 months - 12 months
|
Visual perception function will be assessed with one of 3 tools such as DTVP (Developmental Test of Visual Perception), MVPT (Motor-free Visual Perception Test), and VMI (Visual-Motor Integration, Visual Perception and Motor Coordination).
Higher value means better visual perception ability.
|
Baseline - 3 months - 6 months - 12 months
|
Changes in Selective Movement of Lower Extremity
Time Frame: Baseline - 3 months - 6 months - 12 months
|
SCALE (Selective Control Assessment of Lower Extremity) is a measurement tool of selective movement of hip, knee, ankle, subtalar joint and toes.
Selective voluntary motor control is graded at each joint as normal (2 points), impaired (1 point) or unable (0 point).
|
Baseline - 3 months - 6 months - 12 months
|
Changes in Spasticity
Time Frame: Baseline - 3 months - 6 months - 12 months
|
Muscle spasticity of biceps, hip adductors, hamstrings and heel cords is graded according to modified Ashworth scale (MAS).
|
Baseline - 3 months - 6 months - 12 months
|
Changes in Dynamic Component of Spasticity
Time Frame: Baseline - 3 months - 6 months - 12 months
|
Dynamic component of spasticity in bilateral hamstrings is graded using modified Tardieu scale (MTS).
|
Baseline - 3 months - 6 months - 12 months
|
Changes in Muscle Strength
Time Frame: Baseline - 3 months - 6 months - 12 months
|
Muscle strength is measured using summated scores of manual muscle 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 score means stronger muscle power.
|
Baseline - 3 months - 6 months - 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UCBCP
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
-
Gazi UniversityCompletedCerebral Palsy | Cerebral Palsy, Spastic | Cerebral Palsy Spastic Diplegia | Cerebral Palsy Quadriplegic | Cerebral Palsy, MonoplegicTurkey
-
Northwestern UniversityActive, not recruitingCerebral Palsy | Diplegic Cerebral Palsy | Bilateral Cerebral PalsyUnited States
-
Centre Médico-Chirurgical de Réadaptation des Massues...RecruitingCerebral Palsy, Dyskinetic | Cerebral Palsy, Spastic | Infantile Hemiplegic Cerebral PalsyFrance
-
St Mary's University CollegeUniversity of GloucestershireUnknownCerebral Palsy | Cerebral Palsy Ataxic | Cerebral Palsy, MixedUnited Kingdom
-
Hilde FeysHasselt University; ETH Zurich; Curtin UniversityRecruitingHemiplegic Cerebral Palsy | Cerebral Palsy, SpasticBelgium
-
University of California, San FranciscoNational Institutes of Health (NIH)RecruitingDystonic Cerebral Palsy | Dyskinetic Cerebral PalsyUnited States
-
East Carolina UniversityRecruitingHemiplegic Cerebral Palsy | Unilateral Cerebral Palsy | Remote Ischemic ConditioningUnited States
-
MTI UniversityEnrolling by invitationSpastic Diplegic Cerebral PalsyEgypt
-
October 6 UniversityCompletedSpastic Cerebral Palsy | Spastic Hemiplegic Cerebral PalsyEgypt
-
Marmara UniversityUnknownCerebral Palsy, Spastic | Cerebral Palsy, Spastic, DiplegicTurkey
Clinical Trials on Allogeneic umbilical cord blood therapy
-
MinYoung Kim, M.D.Completed
-
Bundang CHA HospitalWithdrawn
-
MinYoung Kim, M.D.CHA UniversityCompletedGlobal Developmental DelayKorea, Republic of
-
BHI Therapeutic SciencesUnknownAcute Ischemic StrokeUnited States
-
MinYoung Kim, M.D.Completed
-
Joanne Kurtzberg, MDThe Marcus FoundationCompleted
-
Guangdong Women and Children HospitalUnknownSafety Issues | Effect of DrugsChina
-
Guangdong Women and Children HospitalRecruitingSafety Issues;Effect of DrugsChina
-
Pomeranian Medical University SzczecinUnknownNecrotizing Enterocolitis | Intracranial Hemorrhages | Retinopathy of Prematurity | Respiratory Distress Syndrome, Newborn | Anemia, Neonatal | Bronchopulmonary DysplasiaPoland