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| Name | Class |
|---|---|
| Fifth Affiliated Hospital of Guangzhou Medical University | OTHER |
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The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for cerebral hemorrhage sequela.
Human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into neural cells, which have been confirmed in in vivo and in vitro experiments. There have been few clinical reports describing umbilical cord mesenchymal stem cells for treatment of cerebral hemorrhage.
To investigate the effects of hUC-MSC treatment for cerebral hemorrhage sequela, 20 patients with cerebral hemorrhage will be enrolled and receive 4 times of hUC-MSC transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hUC-MSC treatment | Experimental | Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human umbilical cord mesenchymal stem cells | Biological | A single dose of 2×107 hUC-MSC will treated to patients, IV, Repeat every weeks for four times. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety evaluation through vital signs, the results of clinical lab tests and adverse events (AEs) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of infarct size measured by brain MRI | before the transplant and 1, 6, 12 months after transplantation | |
| Modified Barthel index | before and 1, 3, 6 and 12 months after transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ping J Chen, Professor | Fifth Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fifth Affiliated Hospital Immunotherapy center | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| National Institutes of Health stroke scale(NIHSS) score | before the transplant and after the transplant 1, 2 and 3 months |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |