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The study is to investigate the efficacy and safety of autologous transplantation of adipose-derived mesenchymal stem cells in patients with the sequelae caused by severe brain injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesenchymal stem cells treatment | Experimental | All subjects will receive autologous adipose-derived mesenchymal stem cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous adipose-derived mesenchymal stem cells | Biological | Patients will receive five infusions, one month apart, each comprising 5-7x10^7 cells of autologous adipose-derived mesenchymal stem cells. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety evaluation | Safety evaluate through vital signs, the results of clinical lab tests and adverse events (AEs). | 16 months |
| Measure | Description | Time Frame |
|---|---|---|
| Positron emission tomography | 18F-FDG used for the assessment of glucose metabolism in the brain | 13 months |
| Magnetic Resonance Imaging | changes in the volume of brain lesions |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital | Taipei | Taiwan |
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| 16 months |
| Electroencephalogram | improvement of continuous slow-waves and irritative features | 16 months |
| Neuropsychological assessment | 16 months |
| Electrodiagnostic Testing | improvement of subjects' sensory neurologic pathways | 16 months |
| Assessment of language and swallowing functions | changes in levels of severity: normal/slight/mild/moderate/severe | 16 months |
| Measure of the severity of disability | 16 months |
| Assessment of spasticity and strength | 16 months |
| Assessment of brain motor control | measurement of the electrical activities in the muscles during specific testing procedures | 16 months |