NCT03726814Unknown早期 1 期
A Safety and Efficacy Study of Human Peripheral Blood Derived Induced EPCs 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: 2018年12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 EPC transplantation in the brain
详细描述
The purpose of this study is to evaluate the efficacy and safety of transplantation EPCs intervent subjests with cerebral hemorrhagic stroke.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects ≥ 18 and ≤ 80 years of age
- •Subjects was confirmed cerebral hemorrhagic stroke, included at least one of risk factors(Hypertension, diabetes, coronary heart disease, high blood lipid), and Satisfied with one of the following conditions:
- •A. Significant stenosis (> 50%) of the intracranial and extracranial arteries or their branches due to atherosclerosis, or clinical or imaging manifestations of vascular blockage B. Head imaging (CT or MRI) : cerebral hemispheric infarct lesion diameter of > 1.5cm; Or there were more than 2 discontinuous lesions in the blood supply area of the same intracranial external artery.
- •C. Auxiliary examination: color ultrasonography, CTA, MRA or DSA of the blood vessels in the neck confirmed that the intracranial or extracranial stenosis was greater than or equal to 50%；
- •Serum creatinine ≤ 1.5 mg/dl ； Serum ALT/AST）≤2.5×ULN；ALB≥25g/L；
- •Serum creatinine≤ 176.8umol/L（2.0 mg/dl）；
- •Prothrombin time（PT）≤15s，International standardization rates（INR）<1.7；
- •The glucose should be control between 2.8~22.2mmol/L（50~400mg/dl）；
- •Adult patients were willing to use reliable contraceptives (such as condoms) and not to donate sperm throughout the study period and within three months of discharge
- •Subjects and the guardians able to undergo post-physical therapy/rehabilitation
排除标准
- •Non-atherogenic cerebral infarction: cardiogenic embolization, small artery occlusion type IS, other exact etiology IS, and unknown etiology IS
- •Combined with cerebral hemorrhage or previous intracranial external blood history, arteriovenous malformation and aneurysm history, or prone to hemorrhage (platelet count below 100 x 109/L)
- •The vital signs of subjects are not stable
- •Subjects with Class III/IV cardiovascular disability according to the New York Heart Association Classification
- •At rest systolic pressure of 170mmHg or diastolic pressure of 105mmHg, or other indications of uncontrolled hypertension
- •Subjects have one kinds of tumors within 5 years
- •The subject was suffering from neurological or mental illness
- •Subjects had congenital or acquired immune deficiencies, active tuberculosis and other active infections (e.g., pulmonary infection, urinary tract infection, skin infection)
- •Receipt of any investigational drug or device within 3 month
- •Active hepatitis B (HBV DNA>1000copy/mL), hepatitis C or HIV infection
- •Subjects who have other conditions that were not appropriate for the group determined by the researchers.
研究组 & 干预措施
EPC treatment group
Experimental
干预措施: EPC treatment group (Biological)
结局指标
主要结局
Incidence of Treatment Emergent AE
时间窗: 1 year
Defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment
次要结局
未报告次要终点
研究者
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