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| Name | Class |
|---|---|
| Ministry of Health & Welfare, Korea | OTHER_GOV |
| LG Life Sciences | INDUSTRY |
| Chong Kun Dang Pharmaceutical | INDUSTRY |
| CHA University |
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This randomized controlled study aims to evaluate the efficacy and safety of allogeneic umbilical cord blood therapy combined with erythropoietin for children with cerebral palsy.
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) and erythropoetin (EPO) 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. EPO is also known to have neuroprotective effects.
Based on animal studies and some clinical trials, UCB is suggested as a potential therapy for children with CP. EPO is combined to add synergistic effects to UCB therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UCB and EPO | Experimental | UCB + EPO + Rehabilitation |
|
| UCB and placebo EPO | Active Comparator | UCB + placebo EPO + Rehabilitation |
|
| placebo UCB and EPO | Active Comparator | placebo UCB + EPO + Rehabilitation |
|
| placebo UCB and placebo EPO | Placebo Comparator | placebo UCB + placebo EPO + Rehabilitation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbilical Cord Blood therapy | Procedure | HLA (Human Leukocyte Antigen) typing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Standardized Gross Motor Function | 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 - 1 month - 3 months - 6 months - 12months |
| Changes in Motor Performance | 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 - 1 month - 3 months - 6 months - 12 months |
| Changes in Cognitive Neurodevelopmental Outcome | Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Mental Scale (range: 0~178; worst: 0, best: 178) | Baseline - 1 month - 3 months - 6 months - 12 months |
| Changes in Motor Neurodevelopmental Outcome | Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Motor Scale (range: 0~112; worst: 0, best: 112) | Baseline - 1 month - 3 months - 6 months - 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Gross Motor Function Classification System | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MinYoung Kim, M.D., Ph.D. | CHA University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA Bundang Medical Center, CHA University | Seongnam-si | Gyeonggi-do | 463-712 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33246489 | Derived | Min K, Suh MR, Cho KH, Park W, Kang MS, Jang SJ, Kim SH, Rhie S, Choi JI, Kim HJ, Cha KY, Kim M. Potentiation of cord blood cell therapy with erythropoietin for children with CP: a 2 x 2 factorial randomized placebo-controlled trial. Stem Cell Res Ther. 2020 Nov 27;11(1):509. doi: 10.1186/s13287-020-02020-y. |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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| OTHER |
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| Erythropoietin alfa | Biological |
|
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| Rehabilitation | Other | Active rehabilitation |
|
| Placebo UCB | Procedure |
|
| Placebo EPO | Biological |
|
| Baseline - 1 month - 3 months - 6 months - 12 months |
| 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 score means more independent performance in daily activities. | Baseline - 1 month - 3 months - 6 months - 12 months |
| Changes in Functional Performance in Daily Activities | 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 - 1 month - 3 months - 6 months - 12 months |
| Changes in Upper Extremity Function | 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 - 1 month - 3 months - 6 months - 12 months |
| Changes in Visual Perception Test | 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 - 1 month - 3 months - 6 months - 12 months |
| Changes in Selective Movement of Lower Extremity | 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 - 1 month - 3 months - 6 months - 12 months |
| Changes in Spasticity | Muscle spasticity of biceps, hip adductors, hamstrings and heel cords is graded according to modified Ashworth scale (MAS). | Baseline - 1 month - 3 months - 6 months - 12 months |
| Changes in Dynamic Component of Spasticity | Dynamic component of spasticity in bilateral hamstrings is graded using modified Tardieu scale (MTS). | Baseline - 1 month - 3 months - 6 months - 12 months |
| Changes in Muscle Strength | 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 - 1 month - 3 months - 6 months - 12 months |
| Changes in Brain MRI | 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 | 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 | Electroencephalography (EEG) will be performed twice prior to and 12 months after UCB therapy. | Baseline - 12 months |
| Changes in EP | 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 | 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 |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |