Safety and Efficacy of Combined Conditioned Medium With Umbilical Cord Mesenchymal Stem Cells as A Novel Strategy for Acute Stroke Infarct
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change from baseline Brain-Derived Neutrophic Factor at one month, 3 months and 6 months after transplantation
研究概览
简要总结
The purpose of this study was to determine the effectiveness of a combination of intranasal conditioned medium (CM) with intraparenchymal umbilical cord mesenchymal stem cells (UC-MSCs) transplantation in acute stroke patients to induce neurogenesis.
详细描述
This study has 3 arms namely CM and UC-MSCs treatment, UC-MSCs treatment only, and control. The investigator hypothesized that group of CM and UC-MSCs combination is the optimal treatment to induce neurogenesis in stroke patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 25-60 years diagnosed with ischemic stroke acute phase
- •The patient has had a CT scan/MRI of the brain to assess ischemic territory
- •The patient must have an NIH Stroke score of 8-20
- •The patient or legal assistant has obtained detailed informed consent regarding the study protocol and agreeing to participate in the study
- •Patients with The Glasgow Coma Scale (GCS) score > 8
- •Patients with Pt-APTT values within normal limits
排除标准
- •Patients with recurrent stroke in the 6 months preceding the episode current stroke
- •CT or MRI images show midline shift and bleeding transformation
- •Participate in similar studies using CM and/or UC-MSC
- •Patients who are immunocompromised and/or who are receiving therapy immunosuppressive
- •Patients who cannot have a CT or MRI examination due to their condition
- •Patients with impaired renal and hepatic function after the onset of ischemic stroke: Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT) > 5x the upper limit of normal values and a significant increase in urea-creatinine values
- •Patients with a history of malignant tumors or other severe neurologic conditions.
研究组 & 干预措施
Conditioned medium combined with Umbilical cord mesenchymal stem cells treatment
Intranasal of 3 cc of conditioned medium each, for 3 days in a row and Intra-parenchymal transplantation of 20x10^6 UC-MSCs
干预措施: Conditioned Medium (Biological)
Conditioned medium combined with Umbilical cord mesenchymal stem cells treatment
Intranasal of 3 cc of conditioned medium each, for 3 days in a row and Intra-parenchymal transplantation of 20x10^6 UC-MSCs
干预措施: Umbilical Cord Mesenchymal Stem Cells (Biological)
Umbilical cord mesenchymal stem cells treatment
Intra-parenchymal transplantation of 20x10^6 UC-MSCs
干预措施: Umbilical Cord Mesenchymal Stem Cells (Biological)
Standard treatment (control)
Neurologic and Neutrophic Drugs
干预措施: Neurologic and Neutrophic Drugs (Procedure)
结局指标
主要结局
Change from baseline Brain-Derived Neutrophic Factor at one month, 3 months and 6 months after transplantation
时间窗: Before treatment, one month after treatment, 3 months after treatment, and 6 month after treatment
Venous blood collection
Change from baseline Vascular endothelial growth factor at one month, 3 months and 6 months after transplantation
时间窗: Before treatment, one month after treatment, 3 months after treatment, and 6 month after treatment
Venous blood collection
Change baseline Magnetic Resonance Imaging at 6 month after transplantation
时间窗: Before treatment, 6 month after transplantation
To observe the brain development (neurogenesis)
次要结局
- The National Institute of Health Stroke Scale (NIHSS) Scoring(Before treatment, one month after treatment, 3 months after treatment, and 6 month after treatment)
- modified Rankin Scale (mRS)(Before treatment, one month after treatment, 3 months after treatment, and 6 month after treatment)