Safety and Effectiveness of Autologous Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With CP

Study Overview
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Brief Summary
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Safety and Effectiveness of Autologous Adipose Tissue Derived mesenchymal Stem Cell Implantation in Patients with CP

Detailed Description
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The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with Cerebral Palsy(CP)

Official Title
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Safety and Effectiveness of Autologous Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With Cerebral Palsy (CP)

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Biological: ASTROSTEM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children with spastic cerebral palsy of spastic paraplegia or quadriplegia involving the two side occurred at birth or before birth Age : 36 months - 12 year, males and females Subjects who understand and sign the consent form for this study Kaufman Assessment Battery for Children 50<K-ABC<100 Exclusion Criteria: The last three months had seizures or epilepsy patients taking the durg Genetic Diseases Recent cancer patients within 1 year patients witn a psychiatric disorder that may interfere in the clinical trial participating another clinical trials within 3 months Recently there is a change of the abrupt symptoms within three months of the patient Subjects with a infectious disease include HIV and VDRL Patients who penicillin hypersensitivity reactions Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria

Ages Eligible for Study
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Minimum Age: 36 Months
Maximum Age: 12 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Astrostem<br>Autologous Adipose Tissue Derived Mesenchymal Stem Cells | Biological: ASTROSTEM<br>* Intravenous injection of Autologous Adipose derived mesenchymal stem cells. Dose : 15kg below : 0.5x10^7cells/5mL 15kg   25kg : 1x10^8cells/10mL 25kg over : 1.5x10^8cells/15mL<br>* Other names: Autologous Adipose Tissue Derived Mesenchymal Stem Cells;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kaufman Assessment Battery for Children (K-ABC) | Change from Baseline K-ABC at 12 months | Baseline and 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood concentration test | Change from baseline concentration of dopamine, acetylcholine, serotonin at 1, 3, 6 and 12 month | Baseline, 1, 3, 6 and 12 month | 
| Gross Motor Function Measurement (GMFM) | Change from Baseline GMFM at 12 months | Baseline, 3, 6 and 12 month | 
| Box and Block Test | Change from Baseline Box and block test at 12 months | Baseline, 3, 6 and 12 month | 
| Modified Ashworth Scale (MAS) | Measurement of resistance during soft-tissue stretching Scale range is 0(no increase in muscle ton) to 4(affected part rigid in flexion or extension) Change from Baseline MAS at 12 months | Baseline, 3, 6 and 12 month | 
| SF-36 | SF-36 is a survey to measure Mental & Physical Health Score range is 0 to 100(the lower the score, the more disability) Change from Baseline SF-36 at 12 months | Baseline, 3, 6 and 12 month | 
| Verification of ASTROSTEM's effect on the brain through fMRI & MRS (Magnetic Resonance Spectroscopy) scan | Changes in fMRI & MRS scan from baseline to 6, 12 month | Baseline, 6 and 12 month | 
| Kaufman Assessment Battery for Children (K-ABC) | Change from Baseline K-ABC at 6 months | Baseline and 6 month |