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| Name | Class |
|---|---|
| Kyung Hee University Hospital at Gangdong | OTHER |
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Safety and Effectiveness of Autologous Adipose Tissue Derived mesenchymal Stem Cell Implantation in Patients with CP
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Astrostem | Experimental | Autologous Adipose Tissue Derived Mesenchymal Stem Cells |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASTROSTEM | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Kaufman Assessment Battery for Children (K-ABC) | Change from Baseline K-ABC at 12 months | Baseline and 12 month |
| 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) |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KyungHee University Gandong Hospital | Seoul | South Korea |
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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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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) |
| Baseline, 3, 6 and 12 month |
| SF-36 |
| 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 |