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| Name | Class |
|---|---|
| First Hospitals affiliated to the China PLA General Hospital | OTHER_GOV |
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The purpose of this study is to investigate the efficacy and safety of NeuroRegen Scaffold with bone marrow mononuclear cells (BMMCs) on neurological recovery following chronic and complete spinal cord injury, compared to the treatment of surgical intradural decompression and adhesiolysis only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NeuroRegen Scaffold with BMMCs transplantation | Experimental |
| |
| Surgical intradural decompression and adhesiolysis | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeuroRegen Scaffold with BMMCs transplantation | Biological | Patients with chronic SCI (ASIA grade A) will receive NeuroRegen Scaffold with bone marrow mononuclear cells (BMMCs) 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 |
| Magnetic Resonance Imaging (MRI) | The change of treated spinal cord injury will be assessed by Magnetic Resonance Imaging (MRI) before and 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 |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of PLA General Hospital | Beijing | 100101 | China |
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| Surgical intradural decompression and adhesiolysis | Procedure | Patients with chronic SCI (ASIA grade A) will receive intradural decompression and adhesiolysis surgery and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures. |
|
| 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 |
| 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 |
| D014947 | Wounds and Injuries |
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