Functional Neural Regeneration Collagen Scaffold Transplantation in Acute Spinal Cord Injury Patients
NCT ID: NCT02510365
Last Updated: 2020-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
20 participants
INTERVENTIONAL
2015-04-30
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Functional collagen scaffold
Functional neural regeneration collagen scaffold transplantation.
Functional collagen scaffold
Patients will receive functional neural regeneration collagen scaffold and patients will undergo a comprehensive rehabilitation and psychological measures after surgery.
Interventions
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Functional collagen scaffold
Patients will receive functional neural regeneration collagen scaffold and patients will undergo a comprehensive rehabilitation and psychological measures after surgery.
Eligibility Criteria
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Inclusion Criteria
2. Completely spinal cord injury at the cervical and thoracic level (C4-T12).
3. Classification ASIA A, occurring within past 21 days.
4. Patients signed informed consent.
5. Ability and willingness to regular visit to hospital and follow up during the protocol Procedures.
Exclusion Criteria
2. Serious complications (e.g., hydronephrosis due to renal insufficiency, severe bedsores (Ⅲ° above), lower extremity venous thrombosis, severe myositis ossificans).
3. History of life threatening allergic or immune-mediated reaction.
4. Clinically significant abnormalities in routine laboratory examinations (hematology, electrolytes, biochemistry, liver and kidney function tests, urinanalysis).
5. History of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders.
6. Severe arrhythmias (e.g., ventricular tachycardia, frequent superventricular tachycardia, atrial fibrillation, and atrial flutter) or cardiac degree II or above conduction abnormalities displayed via 12-lead ECG.
7. Lactating and pregnant woman.
8. Alcohol drug abuse /dependence.
9. Participated in any other clinical trials within 3 months before the enrollment.
10. A drug or treatment known to cause effect on the central nervous system during the past four weeks.
11. A drug or treatment known to cause major organ system toxicity during the past four weeks.
12. Poor compliance, difficult to complete the study.
13. Any other conditions that might increase the risk of subjects or interfere with the clinical trial.
18 Years
65 Years
ALL
No
Sponsors
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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
General Hospital of Ningxia Medical University
OTHER
Army Medical University, China
OTHER
Chinese Academy of Sciences
OTHER_GOV
Responsible Party
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Jianwu Dai
Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS
Principal Investigators
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Jianwu Dai, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Sciences
Sai Zhang, M.D
Role: STUDY_CHAIR
Affiliated Hospital of Logistics Universtiy of CAPF
Huilin Yang, Ph.D
Role: STUDY_CHAIR
The First Affiliated Hospital of Soochow University
Shuxun Hou
Role: STUDY_CHAIR
First Hospitals affiliated to the China PLA General Hospital
Hechun Xia
Role: STUDY_CHAIR
General Hospital of Ningxia Medical University
Tongwei Chu
Role: STUDY_CHAIR
Army Medical University, China
Locations
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First Hospitals affiliated to the China PLA General Hospital
Beijing, , China
Xinqiao Hospital of Army Medical University
Chongqing, , China
The First Affiliated Hospital of Soochow University
Suzhou, , China
Affiliated Hospital of Logistics Universtiy of CAPF
Tianjin, , China
General Hospital of Ningxia Medical University
Yinchuan, , China
Countries
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Central Contacts
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Facility Contacts
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Shuxun Hou
Role: primary
Jiaguang Tang, Ph.D
Role: backup
Tongwei Chu
Role: primary
Huilin Yang, Ph.D
Role: primary
Qin Shi, Ph.D
Role: backup
Sai Zhang, M.D
Role: primary
Shixiang Cheng
Role: backup
Hechun Xia
Role: primary
Xueyun Liang
Role: backup
References
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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.
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.
Other Identifiers
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CAS-XDA-ACSCI/IGDB
Identifier Type: -
Identifier Source: org_study_id