Cerebral Palsy
Conditions
Keywords
Allogeneic Mesenchymal Stem Cells, Umbilical Cord Mesenchymal Stem Cells, Intrathecal Injection, Cerebral Palsy, Conditioned Medium
Brief summary
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.
Interventions
BIOLOGICALUmbilical Cord Mesenchymal Stem Cells
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.
BIOLOGICALConditioned Medium
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.
OTHERStandard Therapy
Standard therapy for cerebral palsy such as physiotherapy
Sponsors
PT. Prodia Stem Cell Indonesia
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to 3 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed as Cerebral palsy with total body involvement type * Age between 6 month - 3 years old * Parents requesting for cell therapy * The parents give sign in informed consent form do to examination, therapy, blood sampling collection and observation for their child
Exclusion criteria
* Head circumference less than -3 SD (more than 3 cm) Nellhaus standard * Have diagnosed meningitis and encephalitis * Have diagnosed congenital infection i.e. toxoplasmosis, rubella congenital, cytomegalovirus * Have diagnosed metabolic disorder, chromosome disorder, congenital malformation or neuroregeneratif disease * Progressive disorder * Regressive development disorder * Severe anatomical abnormalities in Brain MRI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gross Motor Function | 3 month after stem cells | Gross Motor Function Classification System (GMFCS) |
| Cognitive Function | 3 month after stem cells | Bayley Scales of Infant Development (BSID) version III |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chemical Marker | 3 month after stem cells | 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) |
Countries
Indonesia
Outcome results
None listed