Safety of IV Autologous Mononuclear Cells and Marrow Stromal Cells After Stroke
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- death
研究概览
简要总结
This study will examine the safety of two different cellular therapies in the treatment of stroke.
详细描述
Stroke remains a leading cause of death and disability. A limited number of therapies, such as intravenous tissue plasminogen activator, have been approved to interrupt stroke in the early hours after symptom onset. Many patients are not able to benefit from these therapies, however, and so a need exists for development of new interventions to reduce disability after stroke. This study will be an early step towards this, and will examine the safety of two cell types, mononuclear cells and marrow stromal cells. In each case, the cells will be autologous, specifically being derived from the subject's own bone marrow.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic stroke that is supratentorial in location and < 72 hours old between stroke onset and bone marrow aspiration
- •No major pre-stroke disability
- •NIH stroke scale score of 7-24
- •Able to undergo bedside bone marrow aspiration
- •Age 18-85 years, inclusive
- •Reasonable likelihood of receiving standard physical, occupational and speech rehabilitation therapy
排除标准
- •No major active hematological, immunological, or oncological diagnoses
- •Pregnancy
- •Lactating mothers
- •At least 24 hours time of any thrombolytic therapy and time of bone marrow aspiration
- •Allergy to penicillin or to fetal bovine serum
- •Active, major co-existent neurological or psychiatric disease
- •Infection with HIV, hepatitis B or C, or syphilis
- •Any diagnosis that makes survival to 90 days post-stroke unlikely
- •Participation in an experimental therapeutic clinical trial in the prior three months
研究组 & 干预措施
Placebo
Placebo
干预措施: placebo (Drug)
autologous mononuclear cells
a single intravenous autologous bone marrow mononuclear cell transfusion
干预措施: autologous bone marrow mononuclear cell transfusion (Biological)
autologous marrow stromal cells
a single intravenous autologous marrow stromal cell transfusion
干预措施: marrow stromal cells (Biological)
结局指标
主要结局
death
时间窗: 90 days after stroke onset
次要结局
- other arterial or venous thrombosis(90 days after stroke onset)
- pulmonary embolism(90 days after stroke onset)
- deep venous thrombosis(90 days after stroke onset)
- myocardial infarction(90 days after stroke onset)
- Infection requiring IV antibiotics(90 days after stroke onset)
- ischemic stroke(90 days after stroke onset)
研究者
Steven C. Cramer, MD
Professor
University of California, Irvine