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This open label trial is conducted to investigate the efficacy and safety of the combination therapy of allogeneic umbilical cord blood (UCB) and granulocyte-colony stimulating factor (G-CSF) for patients with brain injury or neurodegenerative disorders.
Current treatments for brain injury or neurodegenerative disorders are palliative rather than curative. Preclinical and some clinical studies suggest that UCB and G-CSF can be used as restorative approach for such disorders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UCB + G-CSF | Experimental | UCB + G-CSF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbilical cord blood therapy | Procedure |
| ||
| Filgrastim |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Berg Balance Scale | Berg Balance Scale for brain injury and parkinson's disease (range: 0 to 56, Higher scores indicates better balance function.) | Baseline - 1 month - 3 months - 6 months |
| Changes in the Level of Disability | FIM (Functional Independence Measure) for brain injury and cerebral palsy (range: 18 to 126, Higher scores indicate more independence in activities of daily living.) | Baseline - 1 month - 3 months - 6 months |
| Changes in Standardized Gross Motor Function | GMFM (Gross Motor Function Measure) for cerebral palsy (range: 0 to 100, Higher scores indicate better gross motor function.) | Baseline - 1 month - 3 months - 6 months |
| Changes in Motor Performance | GMPM (Gross Motor Performance Measure) for cerebral palsy (range: 0 to 100, Higher scores indicate better motor quality.) | Baseline - 1 month - 3 months - 6 months |
| Changes in ALSFRS-R | ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-revised) for ALS (range: 0 to 48, Higher scores indicate better physical function.) | Baseline - 1 month - 3 months - 6 months |
| Changes in UPDRS | UPDRS (Unified Parkinson's Disease Rating Scale) for parkinson's disease (Part 1: mentation, behavior and mood; Part 2: activities of daily living; Part 3: motor examination; Part 4: complications of therapy; Part 5: Schwab and England activities of daily living scale) | Baseline - 1 month - 3 months - 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Brain MRI | Analysis of Diffusion Tensor Image (DTI) for brain injury, cerebral palsy, ALS | Baseline - 6 months |
| Changes in Brain PET | for parkinson's disease |
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Inclusion Criteria: should be included one of the 4 disorders
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA Bundang Medical Center, CHA University | Seongnam-si | Gyeonggi-do | 463-712 | South Korea |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D002547 | Cerebral Palsy |
| D000690 | Amyotrophic Lateral Sclerosis |
| D010300 | Parkinson Disease |
| D019636 | Neurodegenerative Diseases |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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|
| Baseline - 6 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. | 6 months |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D001925 | Brain Damage, Chronic |
| D013118 | Spinal Cord Diseases |
| D016472 | Motor Neuron Disease |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |