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| Name | Class |
|---|---|
| Affiliated Hospital of Logistics University of CAPF | OTHER |
| The First Affiliated Hospital of Soochow University | OTHER |
| First Hospitals affiliated to the China PLA General Hospital | OTHER_GOV |
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The purpose of this study is to assess the safety and efficacy of NeuroRegen scaffold with bone marrow mononuclear cells (BMMCs) or mesenchymal stem cells (MSCs) in patients with chronic spinal cord injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NeuroRegen Scaffold with BMMCs or MSCs transplantation | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeuroRegen scaffold with BMMCs or MSCs transplantation | Biological | Patients with chronic SCI (ASIA grade A) will receive NeuroRegen Scaffold with bone marrow mononuclear cells (BMMCs) or mesenchymal stem cells (MSCs) transplantation after localized scars cleared and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Evaluation Number of patients with adverse events | Number of patients with adverse events is as a measure of safety and tolerability after collagen scaffold with MSCs transplantation. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvements in Neurophysiological Measures omatosensory Evoked Potentials (SSEP) and Motor Evoked Potentials (MEP) monitoring will be assessed | Somatosensory Evoked Potentials (SSEP) and Motor Evoked Potentials (MEP) monitoring will be assessed before and after transplantation. | 12 months |
| Improvements in ASIA Impairment Scale |
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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 |
| Sai Zhang, M.D | Affiliated Hospital of Logistics Universtiy of CAPF | Study Chair |
| Huilin Yang, Ph.D | The First Affiliated Hospital of Soochow University | Study Chair |
| Shuxun Hou | First Hospitals affiliated to the China PLA General Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Hospitals affiliated to the China PLA General Hospital | Beijing | 100037 | China | |||
| The First Affiliated Hospital of Soochow University |
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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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American Spinal Injury Assessment Scale of A, B, C, D or E will be assessed before and after transplantation. |
| 12 months |
| Improvements in Independence Measures and Quality of Life | Functional Independence Measure (FIM) and the Quality of Life Questionnaire (EQ 5D) will be assessed before and after transplantation. | 12 months |
| Improvements in Pain assessed based on Visual analog scale (VAS) | Pain intensity will be assessed based on Visual analog scale (VAS) before and after transplantation. | 12 months |
| Improvements in Urinary and Bowel Function assessed based on bladder pressure monitory before and after transplantation | The ability to feel and control urination and bowel will be assessed based on bladder pressure monitory before and after transplantation. | 12 months |
| Changes at the Transplantation Site in Spinal Cord by Magnetic Resonance Imaging (MRI) | The MRI at the transplantation site will be assessed before and after transplantation. | 12 months |
| Suzhou |
| 215006 |
| China |
| Affiliated Hospital of Logistics Universtiy of CAPF | Tianjin | 300162 | China |
| D014947 | Wounds and Injuries |