Autologous Bone Marrow Stromal Cell and Endothelial Progenitor Cell Transplantation in Patients With Ischemic Stroke: a Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of adverse events after infusion of BMSCs or EPCs.
研究概览
简要总结
The purpose of this study is to evaluate the feasibility, efficacy, and safety of autologous transplantation of ex vivo expanded bone marrow stromal cells (BMSCs)and endothelial progenitor cells (EPCs) for treatment of patients with ischemic stroke.
详细描述
This study is a multi-center, single-blind, randomized, parallel controlled trail. Patients with acute cerebral infarcts within the middle cerebral arterial territory and with severe neurological deficits will be enrolled and randomly allocated into 3 groups: autologous BMSCs transplantation group, autologous EPCs transplantation group and Placebo control group. Randomization codes were established by the study statistician and were revealed only to the stem cell laboratory technician responsible for separating the cells into aliquots or preparing the placebo material. All patients will undergo a Bone Marrow aspiration procedure at 7 days after symptom onset. BMSCs and EPCs will be expanded ex vivo and then intravenously infused into own body, respectively. The control group will not receive cell therapy. Observe will followed for up to 1 year after the onset. Neurological score, neuroimaging, mortality of any cause, side effects, and new-onset comorbidities will be monitored and compared between each groups.
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
- Single (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
- •Patients aged 18 to 80 years, within 7 days of the onset of symptoms
- •Ischemic lesion within the MCA territory as assessed using diffusion-weighted imaging (DWI)
- •The National Institutes of Health Stroke Scale (NIHSS) ≥ 7 at day 7 after the onset
- •Signed informed consent
排除标准
- •Lacunar syndrome
- •Diagnosis other than ischemic stroke(eg. Intracranial hemorrhage or Intracranial tumor)
- •Hematological causes of stroke
- •Severe respiratory, hepatic, or renal disorders
- •Presence of severe febrile illness or viral diseases
- •Malignant diseases
- •Presence of autoimmune diseases
- •Positive response of penicillin skin test, or multiple drug allergies
- •Breast-feeding or pregnant women
结局指标
主要结局
Number of adverse events after infusion of BMSCs or EPCs.
时间窗: 1 year
次要结局
- Changes in functional outcomes measured by the modified Rankin Scale (mRS) and the Barthel index (BI).(1 year)
研究者
Zhen-Zhou Chen
Department of Neurosurgery, Zhujiang Hospital
Southern Medical University, China
