NCT02352077Unknown1 期
Safety and Efficacy of NeuroRegen Scaffold™ With Bone Marrow Mononuclear Cells or Mesenchymal 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
- 4
- 主要终点
- Safety Evaluation Number of patients with adverse events
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of NeuroRegen scaffold with bone marrow mononuclear cells (BMMCs) or mesenchymal stem cells (MSCs) in patients with chronic spinal cord injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
Safety Evaluation Number of patients with adverse events
时间窗: 6 months
Number of patients with adverse events is as a measure of safety and tolerability after collagen scaffold with MSCs transplantation.
次要结局
- Changes at the Transplantation Site in Spinal Cord by Magnetic Resonance Imaging (MRI)(12 months)
- Improvements in Independence Measures and Quality of Life(12 months)
- Improvements in Urinary and Bowel Function assessed based on bladder pressure monitory before and after transplantation(12 months)
- Improvements in Neurophysiological Measures omatosensory Evoked Potentials (SSEP) and Motor Evoked Potentials (MEP) monitoring will be assessed(12 months)
- Improvements in ASIA Impairment Scale(12 months)
- Improvements in Pain assessed based on Visual analog scale (VAS)(12 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 (4)
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