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临床试验/EUCTR2014-001912-20-NL
EUCTR2014-001912-20-NL进行中(未招募)1 期

Adult mesenchymal stem cells to regenerate the neonatal brain: the PASSIoN trial (Perinatal Arterial Stroke treated with Stem cells IntraNasally) - PASSIo

niversity Medical Center Utrecht, The Netherlands0 个研究点目标入组 20 人开始时间: 2015年9月9日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
20

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • - (Near-)Term infants, =36+0 weeks of gestation, admitted to one of the Dutch NICUs, diagnosed with PAIS, confirmed by MRI within 3 days after presentation with clinical symptoms.
  • - PAIS as characterized by a predominantly unilateral ischemic lesion within the territory of the middle cerebral artery
  • - Written informed consent from custodial parent(s)
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 20
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • - Any proven or suspected congenital anomaly, chromosomal disorder, metabolic disorder.
  • - Presence of an infection of the central nervous system.
  • - No realistic prospect of survival, (e.g. severe brain injury), at the discretion of the attending physician.

研究者

发起方
niversity Medical Center Utrecht, The Netherlands

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