NeuroRegen Scaffold™ With Stem Cells for Chronic Spinal Cord Injury Repair
NCT ID: NCT02352077
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
30 participants
INTERVENTIONAL
2015-01-31
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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NeuroRegen Scaffold with BMMCs or MSCs transplantation
NeuroRegen scaffold with BMMCs or MSCs transplantation
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.
Interventions
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NeuroRegen scaffold with BMMCs or MSCs transplantation
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.
Eligibility Criteria
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Inclusion Criteria
2. Completely spinal cord injury at the cervical and thoracic level (C5-T12).
3. Classification ASIA A with no significant further improvement.
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
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
Locations
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First Hospitals affiliated to the China PLA General Hospital
Beijing, , China
The First Affiliated Hospital of Soochow University
Suzhou, , China
Affiliated Hospital of Logistics Universtiy of CAPF
Tianjin, , China
Countries
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Other Identifiers
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CAS-XDA-SCI/IGDB
Identifier Type: -
Identifier Source: org_study_id