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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 efficacy and safety of mesenchymal stem cells or neural stem cells combined with NeuroRegen scaffold transplantation in patients with spinal cord injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NeuroRegen scaffold/mesenchymal stem cells transplantation | Experimental | Patients receive NeuroRegen scaffold with mesenchymal stem cells transplantation after spinal cord injury. |
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| NeuroRegen scaffold/neural stem cells transplantation | Experimental | Patients receive NeuroRegen scaffold with neural stem cells transplantation after spinal cord injury. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeuroRegen scaffold/mesenchymal stem cells transplantation | Biological | Patients with chronic SCI (ASIA grade A) will receive NeuroRegen Scaffold with 10 million mesenchymal stem cells transplantation after localized scars cleared and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvements in ASIA (American Spinal Injury Association) Impairment Scale | 24 months | |
| Improvements in Somatosensory Evoked Potentials (SSEP) | 24 months | |
| Improvements in Motor Evoked Potentials (MEP) | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvements in Independence Measures | Functional Independence Measure (FIM) will be assessed before and after surgery. | 1, 3, 6, 12, 18 and 24 months |
| Changes at the transplantation site in spinal cord by Magnetic Resonance Imaging (MRI) |
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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 |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| NeuroRegen scaffold/neural stem cells transplantation | Biological | Patients with chronic SCI (ASIA grade A) will receive NeuroRegen Scaffold with 10 million neural stem cells transplantation after localized scars cleared and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures. |
|
The MRI at the transplantation site will be assessed before and after transplantation.
| 1, 3, 6, 12, 18 and 24 months |
| Improvements in Urinary and Bowel Function | The ability to feel and control urination and bowel will be assessed based on bladder pressure monitory before and after surgery. | 1, 3, 6, 12, 18 and 24 months |
| Safety and Tolerability assessed by Adverse Events | Proportion of patients with postoperative infections and serious adverse events (SAEs) will be assessed by long term follow-up. | Up to 6 months |
| D014947 | Wounds and Injuries |