NCT02688049Unknown1 期
The Efficacy and Safety of NeuroRegen Scaffold™ Combined With Mesenchymal Stem Cells or Neural Stem Cells for Chronic Spinal Cord Injury Repair
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvements in ASIA (American Spinal Injury Association) Impairment Scale
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of mesenchymal stem cells or neural stem cells combined with NeuroRegen scaffold transplantation in patients with spinal cord injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18-65 years old.
- •Completely spinal cord injury at the cervical and thoracic level (C5-T12).
- •Classification ASIA A with no significant further improvement.
- •Patients signed informed consent.
- •Ability and willingness to regular visit to hospital and follow up during the protocol Procedures.
排除标准
- •A current diagnosis of any primary diseases affecting limb functions (e.g., trauma, infection, tumors, congenital malformations, peripheral muscular dystrophy, Huntington's disease, Parkinson's disease).
- •Serious complications (e.g., hydronephrosis due to renal insufficiency, severe bedsores (Ⅲ° above), lower extremity venous thrombosis, severe myositis ossificans).
- •History of life threatening allergic or immune-mediated reaction.
- •Clinically significant abnormalities in routine laboratory examinations (hematology, electrolytes, biochemistry, liver and kidney function tests, urinanalysis).
- •History of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders.
- •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.
- •Lactating and pregnant woman.
- •Alcohol drug abuse /dependence.
- •Participated in any other clinical trials within 3 months before the enrollment.
- •A drug or treatment known to cause effect on the central nervous system during the past four weeks.
- •A drug or treatment known to cause major organ system toxicity during the past four weeks.
- •Poor compliance, difficult to complete the study.
- •Any other conditions that might increase the risk of subjects or interfere with the clinical trial.
结局指标
主要结局
Improvements in ASIA (American Spinal Injury Association) Impairment Scale
时间窗: 24 months
Improvements in Somatosensory Evoked Potentials (SSEP)
时间窗: 24 months
Improvements in Motor Evoked Potentials (MEP)
时间窗: 24 months
次要结局
- Improvements in Urinary and Bowel Function(1, 3, 6, 12, 18 and 24 months)
- Improvements in Independence Measures(1, 3, 6, 12, 18 and 24 months)
- Changes at the transplantation site in spinal cord by Magnetic Resonance Imaging (MRI)(1, 3, 6, 12, 18 and 24 months)
- Safety and Tolerability assessed by Adverse Events(Up to 6 months)
研究者
Jianwu Dai
Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS
Chinese Academy of Sciences
研究点 (1)
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