SAfety of Mesenchymal Stromal Cells for Ischemic Stroke
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 主要终点
- maximum tolerated dose (MTD) of IV MSCs
研究概览
简要总结
The purpose of this study is to determine if mesenchymal stem cells given by IV is feasible and safe in patients with recent ischemic stroke and to decide the maximum tolerated dose when given between 3-10 days after an ischemic stroke.
详细描述
This is a randomized, double-blind, placebo controlled study. . Approximately 48 subjects will be enrolled in the trial, undergo a real or SHAM MSC IV infusion and will be follow out to 1 year. There will potentially be 4 Cohorts with the dose escalation at a 3:1 randomization schedule
Objectives:
- The primary hypothesis' are that intravenous administration of allogeneic bone marrow derived mesenchymal stem cells is feasible and safe in patients with recent ischemic stroke and to determine the maximum tolerated dose (MTD) of IV MSCs when administered sub-acutely between 3-10 days following ischemic stroke.
- The secondary hypothesis is that allogeneic MSC transplantation will improve functional outcome after recent ischemic stroke.
Safety and clinical efficacy points to be evaluated at Day 7 clinic visit, Day 30, Day 60, Day 90, and Day 180. Primary outcome or Primary endpoint of the study is to define the safety or harm of the MSCs
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
- 18 Years 至 83 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute ischemic stroke
- •age 18 to 83 years
- •post stroke mRS > 3
- •NIHSS of 7-25
- •Deficits on the total NIHSS can be lower than 7 provided the patients have moderate aphasia or visual loss (2 on the Best Language or Visual loss NIHSS subcomponent) *Criteria for mRS not used for this category of subjects
- •Last seen normal st within 3-9 days prior to stroke. Time of onset for wake-up stroke will be defined as the time the patient woke up with symptoms.
- •stem cell transplantation procedure must be performed between 3-10 days after stroke symptom onset
排除标准
- •Ischemic stroke, primary hemorrhagic or traumatic lesion of the brain or myocardial infarction within past 30 days prior to current stroke.
- •Mechanical heart valve
- •Uncontrolled seizure disorder, defined as a seizure within the last 6 months
- •Developmental delay
- •Chronic kidney disease
- •Hepatic disease or altered liver function
- •Pulmonary disease
- •Cancer within 5 years prior to study
- •Prior immunosuppression, including chemotherapy within last 3 years
- •Uncorrected coagulopathy or severe anemia
- •Unable to undergo MRI or CT scan
- •Imaging shows clinically significant hemorrhage
结局指标
主要结局
maximum tolerated dose (MTD) of IV MSCs
时间窗: 24 hours
次要结局
- Improved functional outcome(1 year)
研究者
Sean Savitz
Professor, Department of Neurology, Director, Stroke Program
The University of Texas Health Science Center, Houston