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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
78
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.
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.
Indonesian National Brain Center
Jakarta, Indonesia
Gross Motor Function
Gross Motor Function Classification System (GMFCS)
Time frame: 3 month after stem cells
Gross Motor Function
Gross Motor Function Classification System (GMFCS)
Time frame: 6 month after stem cells
Gross Motor Function
Gross Motor Function Measure (GMFM)
Time frame: 3 month after stem cells
Gross Motor Function
Gross Motor Function Measure (GMFM)
Time frame: 6 month after stem cells
Cognitive Function
Bayley Scales of Infant Development (BSID) version III
Time frame: 3 month after stem cells
Cognitive Function
Bayley Scales of Infant Development (BSID) version III
Time frame: 6 month after stem cells
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)
Time frame: 3 month after stem cells
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)
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Standard therapy for cerebral palsy such as physiotherapy
Time frame: 6 month after stem cells