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| Name | Class |
|---|---|
| Affiliated Hospital of Logistics University of CAPF | OTHER |
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The purpose of this study is to assess the safety and efficacy of injectable collagen scaffold combined with Mesenchymal stem cells (MSCs) transplantation in patients with brain injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Hematoma Evacuation | Sham Comparator |
| |
| MSCs Transplantation | Experimental |
| |
| Injectable Collagen Scaffold with MSCs Transplantation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Hematoma Evacuation | Procedure | Stereotactic intracranial hematoma and insert the drainage tube to inhale haematoma. The drainage tube stayed in the position for 1-2 days until adequate drainage of hematomas, and then the drainage tube was pulled out. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events and participants with those adverse events | Proportion of patients with postoperative infections and serious adverse events (SAEs) will be assessed by long term follow-up. | 24 month |
| Measure | Description | Time Frame |
|---|---|---|
| Change in functional outcomes as measured by National Institutes of Health stroke scale (NIHSS) score | baseline, day 1-7, and 1, 3, 6, 12, 18 and 24 month after surgery | |
| Change in motor recovery evaluated by Brunnstrom stage | 1, 3, 6, 12, 18 and 24 month after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianwu Dai, Ph.D | Chinese Academy of Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Logistics Universtiy of CAPF | Tianjin | 300162 | China |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| MSCs Transplantation | Biological | Stereotactic intracranial hematoma and insert the drainage tube to inhale haematoma. The drainage tube stayed in the position for 1-2 days until adequate drainage of hematomas,and 10 million MSCs were transplanted into the hematoma cavity before the drainage tube was pulled out. |
|
| Injectable Collagen Scaffold with MSCs Transplantation | Biological | Stereotactic intracranial hematoma and insert the drainage tube to inhale haematoma. The drainage tube stayed in the position for 1-2 days until adequate drainage of hematomas, and injectable collagen scaffold combined with 10 million MSCs were transplanted into the hematoma cavity before the drainage tube was pulled out. |
|
| Change in self-care ability as measured by Barthel Index (BI) | 1, 3, 6, 12, 18 and 24 month after surgery |
| Change in pain intensity as measured by Visual Analogue Scale (VAS) | 1, 3, 6, 12, 18 and 24 month after surgery |
| Change in electrical brain activity as measured by Electroencephalography (EEG) | baseline, day 1, 4, 7, and 1, 3, 6, 12, 18, 24 month after surgery |
| Changes in brain electrophysiology as measured by Somatosensory evoked potential (SSEP) | baseline, day 1,4,7, and 1, 3, 6, 12, 18, 24 month after surgery |
| Change in brain pathology diagnosed by Head CT scan | baseline, day 1,4,7, and 1, 3, 6, 12, 18, 24 month after surgery |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |