The Effects of Mesenchymal Stem Cell Secretome in Rheumatoid Arthritis 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
- Rheumatoid Arthritis Disease Activity
研究概览
简要总结
This research is a clinical trial of administering mesenchymal stem cell secretome to rheumatoid arthritis patients.
详细描述
This research is experimental. The research subjects were 30 rheumatoid arthritis patients. The control group received a placebo, and the treatment group received mesenchymal stem cell secretome on the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 14th, 21st, and 28th. The data collected were erythroblastic acidity, hsCRP, interlukin 6, DAS-28, and assessment of drug side effects before and after therapy. 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
- •Rheumatoid Arthritis Patients
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: Messenchymal stem cell secretome (Drug)
Placebo
Nacl 0,9% infusion
干预措施: Placebo (Drug)
结局指标
主要结局
Rheumatoid Arthritis Disease Activity
时间窗: The change of Disease activity score patients at 1 months
Disease Activity Score 28-joint count (DAS28) before and after therapy.
次要结局
未报告次要终点
研究者
Nurhasan Agung Prabowo, MD
Head of Hospital Research Unit
Universitas Sebelas Maret