NCT04811651招募中2 期
Umbilical Cord-derived Mesenchymal Stem Cells for Ischemic Stroke (UMSIS): a Prospective, Double-blinded, Randomized Controlled, Pilot Study
General Hospital of Shenyang Military Region1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年3月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Proportion of modified Rankin Scale (mRS) 0-2
研究概览
简要总结
This is a doble blind, placebo controlled clinical trial to assess safety and efficacy of intravenous administration of Umbilical cord-derived Mesenchymal Stem cells in patients with ischemic stroke within 6 months of onset.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Treatment and placebo solutions have identical appearance. Protocols will be designed to ensure that the physician evaluating patient safety and efficacy outcome as well as laboratory analysis, will not have access to the randomisation codes.
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
- •Age: 18-80 years old;
- •Patients with anterior circulation cerebral infarction;
- •NIHSS: 6-25, and the limb movement score is at least 2 points;
- •Hemoglobin > 115g / L, platelet > 100 × 109 / L, leukocyte > 3 × 109 / L;
- •the time from onset to treatment: group A（6-24 hours）、group B（1-3 days）、gourp C（4-7 days）、group D（1-4 weeks）、group E（1-6 months）;
- •The patient or the legal representative of the patient can and is willing to sign the informed consent.
排除标准
- •Patients who need or expect decompressive craniectomy;
- •Patients who need or are expected to receive endovascular treatment ;
- •Patients receiving intravenous thrombolysis;
- •Disturbance of consciousness；
- •Pregnant women or women of childbearing age who have not taken effective contraceptive measures;
- •Intracranial hemorrhagic diseases: cerebral hemorrhage, subarachnoid hemorrhage, etc;
- •Posterior circulation cerebral infarction;
- •Tumor patients;
- •Epilepsy patients;
- •Severe neurological deficit caused by stroke (MRS = 5);
- •Previous diseases with obvious functional impairment, such as Parkinson's disease, motor neuron disease, moderate Alzheimer's disease, osteoarthritis, etc;
- •Patients with history of coagulation disorders, systemic bleeding tendency and thrombocytopenia (< 100000 / mm3);
- •Chronic liver disease, liver and kidney dysfunction, elevated ALT or ast (2 times higher than the upper limit of normal value), elevated serum creatinine (1.5 times higher than the upper limit of normal value) or dependent on renal dialysis;
- •Patients with moderate to severe mental illness obviously interfere with treatment compliance;
- •Patients with high blood pressure (systolic blood pressure > 180mmhg) or low blood pressure (systolic blood pressure < 90mmHg);
- •The expected survival time is less than one year;
- •Those who have conducted other trials within 3 months;
- •Other circumstances considered unsuitable by the researcher.
研究组 & 干预措施
Treatment group
Experimental
intravenous umbilical cord derived mesenchymal stem cells
干预措施: Umbilical Cord-derived Mesenchymal Stem Cells (Biological)
Placebo Comparator
Placebo Comparator
intravenous placebo solution with the same appearance as the treatment group.
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of modified Rankin Scale (mRS) 0-2
时间窗: 90 Days
the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS mean a worse outcome
次要结局
- Proportion of modified Rankin Scale (mRS) 0-2(180，360 Days)
- changes in box and block test(90days；180days；360days)
- Proportion of modified Rankin Scale (mRS) 0-1(90days；180days；360days)
- changes in Montreal Cognitive Assessment (MoCA) score(90days；180days；360days)
- The changes of head images(90days；180days；360days)
- changes in Fugl-Meyer scale(90days；180days；360days)
- changes in Purdue hand function test(90days；180days；360days)
- changes in Mini-mental State Examination (MMSE) score(90days；180days；360days)
- changes in the national institutes of health stroke scale (NIHSS)(90days；180days；360days)
- changes in some serum biomarkers(90days；180days；360days)
研究者
Hui-Sheng Chen
Director of neurology department
General Hospital of Shenyang Military Region
研究点 (1)
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