JPRN-jRCT2053210009进行中(未招募)1 期
An Exploratory Study to Investigate the Safety and Efficacy of UC-MSCs in Pediatric Patients with Cerebral Palsy
Ookawa Sumito0 个研究点目标入组 6 人开始时间: 2021年4月21日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 6
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
- >= 1age old 至 < 2age old(—)
- 性别
- All
入选标准
- •1) Age >= 12 months and < 24 months corrected age at the time of informed consent
- •2) Diagnosed with cerebral palsy
- •3) Diagnosed with PVL
- •4) GMFCS level between II and IV
- •5) Able to obtain written infomed consent from parents (legal representative)
排除标准
- •1) Presence of progressive neurological disease
- •2) Presence of congenital anomaly
- •3) Diagnosed with Grade 3 or more severe IVH
- •4) Body weight < 5kg
- •5) Profound intellectual disorder
- •6) Complication of serious infection such as sepsis
- •7) Requirement of mechanical ventilation
- •8) Complication of serious organ failure such as kidney, liver or heart diseases or others and considered to be inappropriate
- •9) Diagnosed with or suspected of hypsarrhythmia
- •10) Positive for HBV, HCV, HIV or HTLV-1
- •11) Patients who have recived cell therapy
- •12) Patients who have undergone SDR or received botulinum toxin products within a certain period of time
研究者
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