jRCT2013210056招募中不适用
Clinical trial to verify safety and efficacy of Stemirac that does not meet in-process control specifications and shipping specifications for acute traumatic spinal cord injury patients.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 主要终点
- ISCSCI-92
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- No limit 至 No limit（—）
- 性别
- All
入选标准
- •(1) Patients with AIS A~D SCI 6-8 weeks after injury.
- •(2) The patients who do not meet some in-process control specifications and shipping specifications, but conform to the standards of the investigational product.
- •(3) Patients who can receive rehabilitation at least 4 units a day.
- •(4) The written informed consent from subjects or legal representative is provided. (The written informed consent obtained as much as possible from subjects. If the subject does not have ability to write etc, the written informed consent obtained from legal representative.)
排除标准
- •(1) The patient is not the origin of the product.
- •(2) The past-history of hypersensitivity to RPMI1640, Dimethyl sulfoxide, or Dextran
- •(3) JCS III-200 or III-300
- •(4) Severe respiratory distress
- •(5) Diagnosed as HBV, HCV, HIV, HTLV-1, Human parvovirus B19 or syphilis
- •(6) Patients with the following complications neoplasms (except CR), severe diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism, severe mental and behavioural disorders, severe diseases of the nervous system, severe congenital malformations, deformations and chromosomal abnormalities
- •(7) Past history of penicillin and streptomycin allergies or other severe allergies (shock, anaphylactoid symptoms, etc.)
- •(8) Poor general condition due to [endocrine, nutritional and metabolic diseases, mental disorders, diseases of nervous system, diseases of the circulatory system (Uncontrollable and refractory heart failure, moderate or severe valvular heart disorder, uncontrollable and refractory atrial fibrillation, refractory atrial and ventricular thrombus, history of ischemic heart disease and PCI within the past 12 months, serious arrhythmia), diseases of the respiratory system, diseases of the digestive system, diseases of the musculoskeletal system and connective tissue, diseases of the genitourinary system (dialysis etc), injury, poisoning and certain other consequences of external causes etc]
- •(9) Severe polytrauma or multiple organ dysfunction
- •(10) Has severe spinal cord / spinal disease (severe osteoporosis, spinal cord tumor, spinal vascular malformation, severe syringomyelia, etc.).
- •(11) Intracranial lesions (severe asymptomatic lesion, severe old infarction, severe white matter lesion, severe multiple lesions, severe microbleeding or multiple hemosiderosis, Cerebrovascular diseases such as Moyamoya disease or high risk AN etc, severe intracerebral hemorrhage etc) including past history of these issues.
- •(12) 70% or more stenosis or dissecting in the artery causing cerebral infarction even though after revascularization (except complete thrombotic occlusion)
- •(13) Severe arteriosclerotic changes and calcification in the blood vessels of head and neck.
- •(14) Preoperative possible uncontrollable HT under depressor therapy (systolic pressure more than 140mmHg, diastolic pressure more than 90mmHg)
- •(15) Participation in another clinical trials related to any organ or past history of cellular therapy
- •(16) Pregnant or possibly pregnant, nursing women or those who plan to be pregnant during the study period or male patients who wish the partner to get pregnant
- •(17) Other patients judged by investigators holding medical license as inappropriate for this study
结局指标
主要结局
ISCSCI-92
时间窗: from 6 to 8 weeks after injury to 6 months after injury
Changes in motor function
次要结局
未报告次要终点
研究者
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