Safety of Escalating Doses of Intravenous Bone Marrow-Derived Mesenchymal Stem Cells in Patients With a New Ischemic Stroke
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of Adverse Events
研究概览
简要总结
Stroke is a major cause of adult disability. Currently approved reperfusion therapies are provided to only a small percentage of patients in the U.S. New therapies are needed that improve outcome and that can be accessed by a majority of patients. Animal studies suggest that bone marrow-derived mesenchymal stem cells, administered intravenously days after a stroke, safely improve long-term behavioral outcome. A large human experience suggests the safety of allogeneic bone marrow-derived mesenchymal stem cells. The current study aims to assess the safety of this therapy in patients with recent ischemic stroke.
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)
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
- •Ischemic stroke in the middle cerebral artery territory, with onset 24-72 hours prior to the time that the therapy transfusion is initiated, radiologically confirmed, and with either diameter >15 mm or volume > 4cc.
- •The index stroke has clinical deficits that are moderate-severe (NIHSS score 7-20), did not require hemicraniectomy or invasive intracranial pressure monitoring, and was not associated with a concomitant STelevation myocardial infarction.
- •Age 18-80 years, inclusive
- •Reasonable likelihood of receiving standard post-stroke medical care, as well as standard physical, occupational, and speech therapy.
排除标准
- •No substantial pre-stroke disability (pre-stroke modified Rankin Scale score 0-2).
- •Females of child-bearing potential will be excluded unless (1) a negative urine pregnancy test is obtained and (2) the patient has been effectively using contraceptive method with known failure rate <1 % for at least 90 days.
- •Lactating mothers
- •If thrombolytic therapy has been administered, at least 24 hours have passed between completing thrombolytic dosing and initiating the current study's transfusion.
- •Known allergy to penicillin or to fetal bovine serum
- •Active co-existent major neurological or psychiatric disease that could significantly interfere with patient compliance or study assessments, including drug or alcohol abuse.
- •Any diagnosis that makes survival to 1-year post-stroke unlikely.
- •Participation in any other experimental therapeutic clinical trial concurrently or in the prior three months.
- •Contraindication to undergoing MRI scanning.
研究组 & 干预措施
mesenchymal stem cells
bone marrow-derived mesenchymal stem cells
干预措施: bone marrow-derived mesenchymal stem cells (Biological)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Adverse Events
时间窗: 1 month after transfusion
次要结局
未报告次要终点
研究者
Steven C. Cramer, MD
Professor
University of California, Irvine