Evaluation of Safety and Efficacy in Patients With Aplastic Anemia by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Hemoglobin levels in peripheral blood
研究概览
简要总结
This study is to evaluate the safety and efficacy of Umbilical Cord Derived Mesenchymal Stem Cells transplantation in aplastic anemia.
详细描述
Aplastic anemia (AA) is a disorder thought to be caused by an immune-mediated bone marrow failure. Not all people with AA are eligible for today's standard treatments. One new treatment approach uses umbilical cord derived mesenchymal stem cells-specialized cells capable of developing into other types of cells-to provide the basis for clinical application. The aim of the present study is to investigate the safety and efficacy of vein infusion of allogeneic mesenchymal stem cells in patients with AA .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of AA according to established criteria in 2010
- •Age from 14 to 60 years
- •Suffering from AA within six months
- •No serious infection or acute hemorrhage.
- •Left ventricular ejection fraction (LVEF) ≥ 50%
- •No acute infectious diseases.
- •Understanding and willingness to sign a written informed consent document.
- •Eastern Cooperative Oncology Group(ECOG) score of 0-2pionts.
排除标准
- •Patients with AA have to be disqualified from this study if any of the following is applicable.
- •Severe aplastic anemia(SAA) with severe infection.
- •Severe aplastic anemia(SAA) with active hemorrhage.
- •Severe heart attack, liver and kidney disease following serious complications
- •Patients with allergic constitution.
- •Pregnancy and lactation.
- •Accompanied by malignant tumors and other clonal disease.
- •Patients with active tuberculosis, acute sever hepatitis or infectious period of diseases.
研究组 & 干预措施
mesenchymal stem cells
According to the inclusion and exclusion criteria, selected patients were divided into a cell therapy group and a control group. Umbilical cord derived mesenchymal stem cells at a dose of 100-300 million by intravenous infusion.
干预措施: mesenchymal stem cells (Biological)
结局指标
主要结局
Hemoglobin levels in peripheral blood
时间窗: Post cell transplantation: 9months
The recovery of bone marrow erythrocyte is evaluated by hemoglobin levels (g/L) in peripheral blood.
次要结局
- The number of red blood cell in peripheral blood(Post cell transplantation: 1, 3, 6, 9months)
- adverse reaction(Post cell transplantation: 1, 3, 6, 9months)
- The number of granulocyte in peripheral blood(Post cell transplantation: 1, 3, 6, 9months)
- The number of white blood cell in peripheral blood(Post cell transplantation: 1, 3, 6, 9months)
- The evaluation of bone marrow megakaryocytic series(Post cell transplantation: 1, 3, 6, 9months)
研究者
Quanhai Li
Director of Cell Thearpy Center, the First Hospital of HeibeiMU
Hebei Medical University