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| Name | Class |
|---|---|
| Affiliated Hospital of Logistics University of CAPF | OTHER |
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The study is designed to assess the role of functional neural regeneration collagen scaffold transplantation combined with epidural electrical stimulation in spinal cord injury patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidural Electrical Stimulation | Experimental |
| |
| Functional scaffold & Epidural Electrical Stimulation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidural Electrical Stimulation | Device | Participants had finished the previous clinical trial with functional neural regeneration collagen scaffold transplantation, and will receive epidural electrical stimulation of the spinal cord in this group. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in ASIA Impairment Scale | American Spinal Injury Association Impairment Scale of A, B, C, D or E will be assessed before and after transplantation. | Baseline, 1, 3 , 6, 12 and 24 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ASIA motor score | Baseline, 1, 3 , 6, 12 and 24 months post-treatment | |
| Change in Functional Independence Measure (FIM) | Baseline, 1, 3 , 6, 12 and 24 months post-treatment | |
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Inclusion Criteria:
The enrolled participants are divided into three categories:
Inclusion Criteria For All The Participants
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guang Han | Contact | 86-22-60577133 | hanguang2006@126.com |
| 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 | Recruiting | Tianjin | 300162 | China |
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| Functional scaffold & Epidural Electrical Stimulation | Combination Product | Participants with acute complete SCI or chronic complete SCI will receive functional neural regeneration scaffold transplantation and epidural electrical stimulation of the spinal cord. |
|
| Change in Somatosensory Evoked Potentials (SSEP) monitoring |
| Baseline, 1, 3 , 6, 12 and 24 months post-treatment |
| Change in Motor Evoked Potentials (MEP) monitoring | Baseline, 1, 3 , 6, 12 and 24 months post-treatment |
| Changes at the Transplantation Site in Spinal Cord by Magnetic Resonance Imaging (MRI) | Baseline, 1, 3 , 6, 12 and 24 months post-treatment |
| Change in Walking Speed | Baseline, 1, 3 , 6, 12 and 24 months post-treatment |
| Change in Stride length | Baseline, 1, 3 , 6, 12 and 24 months post-treatment |
| 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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