The Effects of Mesenchymal Stem Cell Secretome in Lupus Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Lupus Disease activity
研究概览
简要总结
This research is a clinical trial of administering mesenchymal stem cell secretome to lupus patients.
详细描述
This research is experimental. The study was conducted on 30 SLE patient subjects. the treatment group who got the mesenchymal stem cell secretome on the 1st, 2nd day, 3rd, 4th, 5th, 6th, 7th, 14th, 21st, and 28th days. ESR, hs-CRP, C3, C4, interlukin 6, anti-ds-DNA antibody, MEX SLEDAI score, and assessment of drug side effects before and after therapy were collected. Statistical test with paired difference test with p < 0.05
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Mesenchymal stem cell placebo and secretome using injections that are similar in shape and color
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lupus paatients
排除标准
- •Pregnancy
研究组 & 干预措施
Messenchymal stem cell secretome
The hypoxic mesenchymal stem cell secretome has been developed up to chapter 7, stored at -196 C to -135 C in cryopreservation, and has passed quality tests.
干预措施: Secretome (Drug)
Placebo
Nacl 0,9% infusion
干预措施: Placebo (Drug)
结局指标
主要结局
Lupus Disease activity
时间窗: Change of Lupus Disease Activity at 1 months
The data collected were MEX SLEDAI score (range 0-32) before and after therapy.
次要结局
未报告次要终点
研究者
Arief Nurudhin
MD. Ph.D
Universitas Sebelas Maret