Cell Therapy by Intravenous Injection of Umbilical Cord Derived Mesenchymal Stem Cells After Stroke
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Number of treatment related-adverse events during the study period.
研究概览
简要总结
The study aims at estimating the safety and efficacy of the intravenous injection of human umbilical cord mesenchymal stem cell(hUC-MSC) for patients suffering from ischemic stroke in recent 3 months.
详细描述
Given the attention paid in recent times, in China and elsewhere, to stroke, which is the leading cause of acquired adult disability and has negative effects on patients' quality of life.Therefore,It's little wonder there's much focus there days on treatment of stroke. For the patients who have suffered from ischemic stroke in 3 months, indeed, they have the opportunity to get symptomatic improvement through receiving conventional stroke treatments that including rehabilitation. At the same time, these treatments are ineffective in some cases. Alternatively, the phenomenon of increasing brain plasticity after stroke provoke an essential therapy. Human umbilical cord mesenchymal stem cells treatment enhances a functional improvement after cerebral ischemia, likewise, treament in rodent models are proved effective. Human umbilical cord mesenchymal stem cells therapy performs a role as take the place destroyed cerebral tissue with a stem cells graft. The totality of evidence from trials running umbilical cord mesenchymal stem cells transplanted into patients suffering from ischemic stroke support the safety of this approach. In terms of efficacy, positive results are reported in the majority of the trials.
Our research project involves a development of cell therapy in a phase IIa clinical trial of safety and efficacy in patients (randomised, controlled, open, with 2 parallel 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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Confirmed diagnosis of intracerebral ischemic stroke in three months by Magnetic Resonance Imaging(MRI)
- •Patients have received proper treatment within two weeks from the onset of stroke symptoms.
- •Age between 18 to 70 years old for men or women
- •Patients with persistent neurological deficit .
- •Obtaining informed consent signed (after being informed of the purpose, procedure, and venture of this study, the patient or guardian or legal representative must signing the informed consent document for engagement of participation.
- •Patients basic situation are allowable to be involved in the program.
排除标准
- •Patients with serious extensive stroke, who are unwilling to the risk.
- •Patients with serious persistent neurological deficit (NIHSS > 24).
- •Medical history of neurological pathology with a deficit as consequence (Rankin < 3 before stroke).
- •Patients with serious psychological disease.
- •Patients with myocardial infarction in recent 3 months.
- •Patients with recurring thromboembolic disease in recentin recent 3 months.
- •Patients with organ transplantation.
- •Patients with infection history including Human Immunodeficiency Virus(HIV),Human T-cell Leukemia Virus(HTLV), Hepatitis B Virus(HBV), Hepatitis C Virus(HCV),ect.
- •Patients receive current immunosuppressive/immunomodulating treatment.
- •Patients basic situation are unallowable to be involved in the program.
- •Patients who refuse to participate.
- •Patients who are inability or unwillingness of individual or legal guardian/representative to give written informed consent.
- •Patients who are pregnant or feeding women.
- •Patients who are Participating in another therapeutic clinical trial or in period of exclusion of a therapeutic clinical study.
结局指标
主要结局
Number of treatment related-adverse events during the study period.
时间窗: 180 days after transfusion
次要结局
- Comparison of infarct size measured by brain MRI.(180 days after the cell treatment.)
- Comparison of modified Rankin scale (mRS).(180 days after the cell treatment.)
- Distinguish of EuroQol 5d (EQ-5D) between pre- and post-treatment 180 days.(180 days after the cell treatment.)
- Comparison of National Institutes of Health stroke scale (NIHSS).(180 days after the cell treatment.)