NCT03725865Unknown早期 1 期
A Clinical Study of Intracerebral Transplantation of Human Peripheral Blood Derived Induced Neural Stem Cells for Cerebral Hemorrhagic Stroke
Allife Medical Science and Technology Co., Ltd.0 个研究点目标入组 12 人开始时间: 2019年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 12
- 主要终点
- Incidence of Treatment Emergent AE
研究概览
简要总结
This is a single centre、single arm、open-label，to investigate the safety and efficacy of induction of neural stem cells transplantation in the brain
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have the ability to understand the requirements of the study, provide written informed consent, and comply with the study procedures.
- •Men and women 30-65 years old.
- •Women must have a negative serum pregnancy test, gestation age women practice an acceptable method of contraception.
- •At least 12 months but no more than 60 months from time of hemorrhagic stroke, with a motor neurological deficit.
- •Documented history of single hemorrhagic stroke in subcortical region of MCA or lenticulostriate artery with or without cortical involvement, with correlated findings by MRI.
- •Modified Rankin Score of 2, 3 or
- •FMMS score of 55 or less, two evaluations at approximately 3 weeks apart prior to surgery with less than +/- 5 point change in the FMMS.
- •Two evaluations at approximately 3 weeks apart prior to surgery with less than +/- 4 point change in the NIHSS.
- •Able and willing to undergo post-physical therapy/rehabilitation.
排除标准
- •Any disabling psychological or psychiatric disorders which may confound the study.
- •History of more than one hemorrhagic stroke.
- •History of another major neurological disease or injury.
- •Cerebral soften lesion size >5cm in any one measurement.
- •Myocardial infarction within the prior 3 months.
- •History of seizures or current use of antiepileptic medication.
- •History of peripheral nerve surgery, including Selective Dorsal Rhizotomy and Contralateral Seventh Cervical Nerve Transfer.
- •Receipt of any investigational drug or device within 30 days.
- •Receipt of any cell infusion other than blood transfusion.
- •Any concomitant medical disease or condition noted below:
- •Coagulopathy.
- •Active or history of malignancy.
- •Primary or secondary immune deficiency.
- •Persistent MRI artifact or unable to undergo MRI.
- •Any condition that the Investigator or primary physician feels may interfere with participation in the study or may endanger the subject.
- •Any condition that the surgeon feels may pose complications for the surgery.
研究组 & 干预措施
iNSC treatment group
Experimental
干预措施: Induction of neural stem cells (Biological)
结局指标
主要结局
Incidence of Treatment Emergent AE
时间窗: 1 year
次要结局
未报告次要终点
研究者
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