JPRN-UMIN000040503已完成1 期
The study of intravenous administration of autologous cranial bone derived mesenchymal stem cells for moderate or severe cerebral infarction patients needed decompressive surgery - The study of intravenous administration of autologous cranial bone derived mesenchymal stem cells for moderate or severe cerebral infarction patients needed decompressive surgery
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 3
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
- 20years-old 至 85years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •Exclusion criteria at the time of first registrations 1. Out of standard treatment course in initial treatment of cerebral infarction until surgical decompression (severe hemorrhagic transformation of ischemic lesion, etc.) 2. Other serious illness with contraindication for surgical decompression 3. Positivity for hepatitis B virus, hepatitis C virus, HIV, or human T-cell lymphotropic virus type 1 at the initial screening 4. Significant risk for recurrence of cerebral infarction 5. Active or unstable intracranial lesions such as moyamoya disease, cerebral aneurysms at high risk of causing rupture or embolism, and severe intracranial hemorrhage . 6. Other serious comorbidity that could affec t outcome ( presence of a malignant tumor , uncontrolled proliferative diabetic retinopathy, etc.) 7. Serious allergy to any possible residues in the test product ( e .g . any biomaterials used in manufacturing process , and gentamicin sulfate ) or any agents used for the administration of the test product or any inspections during the trial 8. Significant abnormal laboratory tests ( severe medical complications such as kidney dysfunction, liver dysfunction, etc.) 9. Participate in other clinical trial 10. Pregnant or possibly pregnant, lactating women, fertile women who are unable to practice contraception 11. Improper on the basis of the judgement by primary investigator or other investigators Secondary registration selection exclusion criteria 1. Deep coma or coma evaluated by Japan Coma Scale (JCS; 300 or 200) 2.Out of the standard course of treatment for preceding cerebral infarction 3. There is a prospect that Autologous cranial bone derived mesenchymal stem cells that do not meet shipping criteria in post-production quality inspection not available 4. Improper on the basis of the judgement by primary investigator or other investigators
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