Stem Cell and Conditioned Medium for Cerebral Palsy

Study Overview
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Brief Summary
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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.

Official Title
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Allogeneic Umbilical Cord Mesenchymal Stem Cells and Conditioned Medium for Cerebral Palsy in Children

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Biological: Umbilical Cord Mesenchymal Stem Cells
* Biological: Conditioned Medium
* Other: Standard Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UCMSCs + CM<br>UCMSCs + CM is administered via intrathecal injection | Biological: Umbilical Cord Mesenchymal Stem Cells<br>* 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.<br>* Other names: Allogeneic Mesenchymal Stem Cells;Biological: Conditioned Medium<br>* 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.<br>* Other names: Umbilical Cord Mesenchymal Stem Cells derived Conditioned Medium;|
| Experimental: UCMSCs<br>UCMSCs is administered via intrathecal injection | Biological: Umbilical Cord Mesenchymal Stem Cells<br>* 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.<br>* Other names: Allogeneic Mesenchymal Stem Cells;|
| Active Comparator: Standard Therapy<br>Physiotherapy | Other: Standard Therapy<br>* Standard therapy for cerebral palsy such as physiotherapy<br>* Other names: Physiotheraphy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allogeneic Mesenchymal Stem Cells, Umbilical Cord Mesenchymal Stem Cells, Intrathecal Injection, Cerebral Palsy, Conditioned Medium