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临床试验/IRCT20110628006907N18
IRCT20110628006907N18尚未招募2 期

A Triple blinded, Parallel Randomized clinical trial Phase II&III of 3 Times Intrathecal Injections of an Umbilical Cord-Derived Mesenchymal Stromal Cell Product WhartoCell” in Children with Cerebral Palsy

ROYAN stem cell technology Co0 个研究点目标入组 150 人开始时间: 待定最近更新:
适应症

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
150

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
2 years 至 14 years(—)
性别
All

入选标准

  • Spastic cerebral palsy (Dip, Quadri, Hemiparetic ) Ages between 2 - 14 years Gross motor function classification (GMFC) 2 -4 No seizure disorder or with controlled seizure Acquired brain MRI finding compatible with CP Informed consent of parents

排除标准

  • Normal brain MRI Progressive neurological diseases Congenital brain cortical malformations TORCH infections( Toxoplasmosis, Others, Rubella Cytomegalovirus Hepatitis C ) Other types of cerebral palsy (athetoid , atonic , ataxic , mixed ) Acute infections (Human Immunodeficiency Virus , Hepatitis C Virus ) Hemorrhagic diathesis Severe anemia ( Hemoglobin less than 8 ) Ventilator dependent pulmonary diseases Severe renal dysfunction Severe liver dysfunction

研究者

发起方
ROYAN stem cell technology Co

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