JPRN-UMIN000035074已完成未知
Regenerative medicine for spinal cord injury at subacute stage using human induced pluripotent stem cell-derived neural stem/progenitor cells - Transplantation of iPSC-NS/PCs for subacute-stage spinal cord injury
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1)Condition of spinal cord injury Multiple or transection injury of spinal cord, or combined damage of dural membrane by preoperative MRI imaging. 2)Past history, comorbidity History of spinal cord injury, or history or coexistence of abnormalities in the spinal cord or intrathecal space (tumors, inflammation, hemorrhage, etc.). Difficult or unable to capture MRI image (such as patients with the pacemaker in the heart). History or coexistence of intoxication of alcohol or other drugs. 3)Comorbidity Major respiratory complications which require tracheal intubation, tracheostomy, or ventilation. Trauma, or organ injuries that interfere with safety / efficacy evaluation. Other severe or uncontrolled medical complications including heart failure, diabetes mellitus, hypertension, interstitial pneumonia, renal failure, autoimmune disease, cancer, and mental illness. Active infection that becomes a contraindication for surgery. Dementia or high risk of dementia. 4)Laboratory data WBC<3.5x10^3/mm3, Neutrophil (%)>90, Platelets<1.5x10^5/mm3, Hb<10.0g/dL, PT-INR>1.2 (without the patients with anticoagulant), APTT>41sec(without the patients with anticoagulant), creatinine>male1.1mg/dL, female 0.8mg/dL, Hepatic transferase (AST or ALT)>70 IU/L, total bililbin>1.0mg/dL. *The border data can be included (insufficient display of inequality sign due to the system problem) 5)History of Allergy Allergy to FK506. Allergy to ARTCEREB irrigation and perfusion solution for cerebrospinal surgery. 6)Combination therapy Cyclosporine, Bosentan, Pottasium-sparing diuretics at the time of consent. Use of other investigational new drug within 1 months from the time of consent. Use of steroid after spinal cord injury. 7)Pregnancy Women who are pregnant, lactating, or may be pregnant or are planning pregnancy during clinical study participation period. Men who want partner's pregnancy during clinical study participation period. 8)Other patients who are deemed inappropriate by researcher.
研究者
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