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The aim of this study was to compare the effectiveness of umbilical cord mesenchymal stem cells (UCMSCs) and conditioned medium (CM) administration, UCMSCs only and control with standard therapy.
Hypothesis: UCMSCs + CM therapy resulting in higher improvement in cognitive function, gross motor function and chemical factors than UCMSCs and standard therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UCMSCs + CM | Experimental | UCMSCs + CM is administered via intrathecal injection |
|
| UCMSCs | Experimental | UCMSCs is administered via intrathecal injection |
|
| Standard Therapy | Active Comparator | Physiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbilical Cord Mesenchymal Stem Cells | Biological | The umbilical cord was removed from the donor and brought to cell culture facility immediately. Upon arrival, pre-sterility sample testing was performed to ensure the sample was free from contaminant. Culture processes were conducted in a laboratory room where high sterility and safety were guaranteed. Every batch of the cells was monitored by a series of quality control testing to assure the quality of the product. |
| Measure | Description | Time Frame |
|---|---|---|
| Gross Motor Function | Gross Motor Function Classification System (GMFCS) | 3 month after stem cells |
| Gross Motor Function | Gross Motor Function Classification System (GMFCS) | 6 month after stem cells |
| Gross Motor Function | Gross Motor Function Measure (GMFM) | 3 month after stem cells |
| Gross Motor Function | Gross Motor Function Measure (GMFM) | 6 month after stem cells |
| Cognitive Function | Bayley Scales of Infant Development (BSID) version III | 3 month after stem cells |
| Cognitive Function | Bayley Scales of Infant Development (BSID) version III | 6 month after stem cells |
| Measure | Description | Time Frame |
|---|---|---|
| Chemical Marker | Insulin-like growth factor 1 (IGF-1); stromal derived factor-1α (SDF-1α); brain derived neurotrophic factors (BDNF), Vascular endothelial growth factor (VEGF),glial cell line-derived neutrophic factor (GDNF), fibroblast growth factor (FGF), Doublecortin (DCX) | 3 month after stem cells |
| Chemical Marker |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indonesian National Brain Center | Jakarta | Indonesia |
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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 |
|---|---|
| D017077 | Culture Media, Conditioned |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D003470 | Culture Media |
| D019995 | Laboratory Chemicals |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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| Conditioned Medium | Biological | Conditioned medium collected from umbilical cord mesenchymal stem cell (UC-MSC) cultured. Every batch of the conditioned medium was monitored by a series of quality control testing to assure the quality of the product. |
|
|
| Standard Therapy | Other | Standard therapy for cerebral palsy such as physiotherapy |
|
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Insulin-like growth factor 1 (IGF-1); stromal derived factor-1α (SDF-1α); brain derived neurotrophic factors (BDNF), Vascular endothelial growth factor (VEGF),glial cell line-derived neutrophic factor (GDNF), fibroblast growth factor (FGF), Doublecortin (DCX) |
| 6 month after stem cells |
| D004864 | Equipment and Supplies |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |