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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 study is designed to assess the safety and efficacy of functional neural regeneration collagen scaffold transplanted into acute spinal cord injury patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Functional collagen scaffold | Experimental | Functional neural regeneration collagen scaffold transplantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional collagen scaffold | Biological | Patients will receive functional neural regeneration collagen scaffold and patients will undergo a comprehensive rehabilitation and psychological measures after surgery. |
| 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 transplantation. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvements in ASIA Impairment Scale | American Spinal Injury Assessment Scale of A, B, C, D or E will be assessed before and after transplantation. | 12 months |
| Improvements in Electrophysiological monitoring |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhifeng Xiao, Ph.D | Contact | 86-10-82614420 | zfxiao@genetics.ac.cn | |
| Sufang Han, Ph.D | Contact | 86-10-82614420 | sufanghan22@genetics.ac.cn |
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Hospitals affiliated to the China PLA General Hospital | Recruiting | Beijing | 100037 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32862715 | Derived | Chen W, Zhang Y, Yang S, Sun J, Qiu H, Hu X, Niu X, Xiao Z, Zhao Y, Zhou Y, Dai J, Chu T. NeuroRegen Scaffolds Combined with Autologous Bone Marrow Mononuclear Cells for the Repair of Acute Complete Spinal Cord Injury: A 3-Year Clinical Study. Cell Transplant. 2020 Jan-Dec;29:963689720950637. doi: 10.1177/0963689720950637. | |
| 29871514 |
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| General Hospital of Ningxia Medical University | OTHER |
| Army Medical University, China | OTHER |
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Somatosensory Evoked Potentials (SSEP) monitoring will be assessed before and after transplantation.
| 12 months |
| Improvements in Electrophysiological monitoring | Motor Evoked Potentials (MEP) monitoring will be assessed before and after transplantation. | 12 months |
| 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 |
| Hechun Xia | General Hospital of Ningxia Medical University | Study Chair |
| Tongwei Chu | Army Medical University, China | Study Chair |
| Xinqiao Hospital of Army Medical University | Recruiting | Chongqing | 400037 | China |
|
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | 215006 | China |
|
| Affiliated Hospital of Logistics Universtiy of CAPF | Recruiting | Tianjin | 300162 | China |
|
| General Hospital of Ningxia Medical University | Recruiting | Yinchuan | 750004 | China |
|
| Xiao Z, Tang F, Zhao Y, Han G, Yin N, Li X, Chen B, Han S, Jiang X, Yun C, Zhao C, Cheng S, Zhang S, Dai J. Significant Improvement of Acute Complete Spinal Cord Injury Patients Diagnosed by a Combined Criteria Implanted with NeuroRegen Scaffolds and Mesenchymal Stem Cells. Cell Transplant. 2018 Jun;27(6):907-915. doi: 10.1177/0963689718766279. Epub 2018 Jun 5. |