NCT02378974已完成1 期
A Randomized, Double-blind, Placebo-controlled, Phase I/IIa Clinical Trial for Evaluation of Safety and Potential Therapeutic Effects After Intravenous Transplantation of Human Umbilical Cord-derived Mesenchymal Stem Cells in Patients With Cerebral Infarction Disease
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Number of TEAEs
研究概览
简要总结
The objective of the study is to evaluate the safety and the potential therapeutic effects per dose of Cordstem-ST Intravenous Transplantation in Cerebral Infarction subjects
详细描述
Cohort 1 : Cordstem-ST cells or Placebo on day 0 Cohort 2: Cordstem-ST cells or Placebo on day 0 and day 7
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects between 19 to 80 years of age (inclusive) at the time of screening visit
- •Subjects who are able to receive intravenous Cordstem-ST Transplantation within 7 days (168 hours) of stroke onset
- •Subjects with diagnosis of Cerebral Infarction confirmed by the following criteria assessed at the screening visit
- •NIHSS score between 5 and 20 (inclusive)
- •Acute ischemic lesion involving anterior circulation territory identified in the diffusion weighted MRI
- •Signed informed consent
排除标准
- •History of intracranial hemorrhage
- •Subjects who are suspected to undergo endarterectomy during the study period. Subjects who received the former procedures not due to cerebral infarction more than 3 months ago, are eligible.
- •Subjects with hemorrhagic transformation on brain images, except for petechial hemorrhage ('H1' according to the ECASS classification)
- •Subjects at the high risk of developing brain herniation
- •History of dementia
- •History of epilepsy
- •Subjects who have been treated or diagnosed with schizophrenia, depression, or bipolar disorder within the past 6 months
- •Subjects with recent (≤3 months) myocardial infarction or stroke other than the index stroke.
- •Subjects must not have the following conditions in laboratory tests
- •ALT or AST: More than 2.5 times the upper limit of normal
- •Serum creatinine: More than 1.5 times the upper limit of normal
- •Total bilirubin: More than 2.5 times the upper limit of normal
- •Platelet count: less than lower limit of narmal
- •Subjects who are HBV, HCV, HIV, VDRL positive
- •Subjects in poor general condition due to medical conditions or subjects with severe cardiovascular, gastrointestinal, pulmonary, endocrinologic diseases
- •Subjects with active lung diseases, based on chest X-ray
- •Subjects with abnormal coagulopathic conditions (thrombocytopenia, congenital coagulopathy, etc.). Medical use of oral anticoagulants is permitted.
- •Subjects with known allergies to protein products (Bovine serum) used in the cell production process.
- •Subjects with history of pulmonary embolism or deep vein thrombosis
- •Subjects with history of malignancy
- •Pregnant or lactating women
- •Women of childbearing age who reject to practice contraception with one of the following methods
- •Use a condom
- •Use of contraceptive (oral, dermal, or injectable)
- •Use an intra-uterine contraceptive device
- •Subjects with a history of alcohol abuse (>30g/day) or drug abuse
- •Subjects who cannot undergo MRI scanning
- •Subjects who cannot conduct the scheduled monitoring visits
- •Subjects who is determined to be inappropriate by the investigators
研究组 & 干预措施
Cohort 2
Other
Cordstem-ST cells or Placebo on day 0 and day 7
干预措施: Placebo (Biological)
Cohort 1
Other
Cordstem-ST cells or Placebo on day 0
干预措施: Placebo (Biological)
Cohort 2
Other
Cordstem-ST cells or Placebo on day 0 and day 7
干预措施: Cordstem-ST (Biological)
Cohort 1
Other
Cordstem-ST cells or Placebo on day 0
干预措施: Cordstem-ST (Biological)
结局指标
主要结局
Number of TEAEs
时间窗: 6 month
Number of treatment related-adverse events during the study period
次要结局
- Improvement in clinical function as assessed by BI(6 month)
- Improvement in clinical function as assessed by mRS(6 month)
- Improvement in clinical function as assessed by Brain MRI tratogram(6 month)
- Improvement in clinical function as assessed by NIHSS(6 month)
研究者
研究点 (1)
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