Evaluation of Safety and Efficacy in Patients With Systemic Lupus Erythematosus by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The change of Complement levels(C3 and C4) in peripheral blood
研究概览
简要总结
This study is to evaluate the safety and efficacy of human umbilical cord derived mesenchymal stem cells transplantation in systemic lupus erythematosus.
详细描述
To ensure that all patients of systemic lupus erythematosus (SLE) completed 6-months follow-up, twenty SLE patients ranging from 14 to 60 years old were enrolled in this trial. Participants matched with the inclusion criteria were allocated randomly into two groups:Human Umbilical Cord Derived Mesenchymal Stem Cells (hUC-MSCs) treated group and control group. Clinical trials are being increasingly established to investigate the therapeutic potential of these cells for SLE. The aim of the present study is to investigate safety and efficacy of vein infusion of allogeneic hUC-MSCs in patients with SLE.
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 SLE(Systemic lupus erythematosus) from American College of Rheumatology(ACR) according to established criteria in 1997
- •Age from 14 to 60 years
- •No serious infection or acute hemorrhage
- •Left ventricular ejection fraction (LVEF)≥ 50%
- •Both transaminase and serum creatinine level are more than twice times the upper limit of normal
- •No acute infectious diseases.
- •Understanding and willingness to sign a written informed consent document.
排除标准
- •Patients with SLE have to be disqualified from this study if any of the following is applicable:
- •SLE(Systemic lupus erythematosus) with severe infection.
- •Severe heart attack, liver and kidney disease following serious complications
- •Patients with allergic constitution.
- •Pregnancy and breastfeeding women.
- •Accompanied by malignant tumors or other malignant disease
- •Patients as participant in the other clinical text
- •Patients with active tuberculosis, acute sever hepatitis or infectious period of diseases.
研究组 & 干预措施
mesenchymal stem cells
Selected SLE patients were randomly divided into treated group and control group. In the treated group, 100-300 million allogeneic human umbilical cord derived mesenchymal stem cells were infused intravenously for one SLE patient. The possible adverse events, including immediately after mesenchymal stem cells infusions, as well as the long-term safety profiles were observed.
干预措施: mesenchymal stem cells (Biological)
结局指标
主要结局
The change of Complement levels(C3 and C4) in peripheral blood
时间窗: Post cell transplantation: 1, 3, 6 months
The recovery of immunologic function is evaluated by complement levels (g/L) in peripheral blood.
次要结局
- C-reactive protein(Post cell transplantation: 1, 3, 6 months)
- adverse reaction(Post cell transplantation: 1, 3, 6 months)
- Erythrocyte sedimentation rate(Post cell transplantation: 1, 3, 6 months)
研究者
Quanhai Li
Director of Cell Thearpy Center, the First Hospital of HeibeiMU
Hebei Medical University