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临床试验/NCT02241395
NCT02241395撤回1 期

Autologous Bone Marrow Mononuclear Cell Therapy in Cerebral Palsy

Neurogen Brain and Spine Institute2 个研究点 分布在 1 个国家开始时间: 2013年8月最近更新:
适应症

试验速览

阶段
1 期
状态
撤回
试验地点
2
主要终点
change in clinical symptoms over a period of 2 years

研究概览

简要总结

The purpose of this study was to study the effect of autologous bone marrow mononuclear cells on common symptoms of cerebral palsy patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Months 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosed cases of any type of Cerebral Palsy
  • age above 6 months.

排除标准

  • presence of acute infections such as Human immunodeficiency virus/Hepatitis B Virus/ Hepatitis C Virus
  • malignancies
  • bleeding tendencies
  • pneumonia
  • renal failure
  • severe liver dysfunction
  • severe anemia [Hemoglobin < 8]
  • any bone marrow disorder
  • space occupying lesion in brain
  • other acute medical conditions such as respiratory infection and pyrexia.

结局指标

主要结局

change in clinical symptoms over a period of 2 years

时间窗: 2 years

Clinical symptoms such as oromotor skills, sitting and standing balance, speech, ambulation, muscle tone, cognition, hand and leg movement, walking, etc

次要结局

  • Change in GMFM score(1 year)
  • Change in Gross Motor Function Measure(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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Cell Therapy as Treatment for Cerebral Palsy | 临床试验