Research for Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Myelodysplastic Syndrome (MDS)
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Treatment related-adverse events counting
研究概览
简要总结
The purposes of the study is to determine the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSC) in treating Myelodysplastic Syndrome patients.
详细描述
This is a randomized, double-blind, paralleled study. 40 patients will be separated into two groups, and receive basic treatment (Decitabine). Patients in experimental group will receive hUC-MSC, while control group receive placebo (normal saline), four weeks as a course of treatment. All of the patients accept examination before treatment, including
- diagnostic projects: bone marrow test, peripheral blood classification, chromosome, and MDS fusion gene test, etc.;
- routine examination: blood, urine, and stool routine test, X-ray film in chest, electrocardiogram, etc.;
- stem cell-based medicinal products usage, dosage, time, and course of treatment.
Then, patients will accept routine examination everyday, and after treatment, investigator will follow-up for 6 months, to evaluate the security and efficacy of hUC-MSC.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MDS patients with international prostate symptom score is moderate or severe symptoms
排除标准
- •with serious renal function impaired
- •with other organ function abnormal: acute hepatitis B, ejection fraction < 40%, serum bilirubin > 3mg/dl, liver function tests abnormal, central nervous system disease, mental disease
- •bad physical condition (Karmofsky < 60%)
- •without signing informed consent form
- •under other therapy that possibly influence MSC security or efficacy
- •HIV or other serious disease infection
- •Donor: HIV, active hepatitis B/C infection, Syphilitic antibody positive
- •Donor/ participants: alcoholism, drug addicted, mental disease
研究组 & 干预措施
Experimental group
Basic medication: Decitabine; Allogeneic umbilical cord mesenchymal stem cells.
干预措施: Decitabine (Drug)
Experimental group
Basic medication: Decitabine; Allogeneic umbilical cord mesenchymal stem cells.
干预措施: Allogeneic umbilical cord mesenchymal stem cells (Biological)
Control group
Basic medication: Decitabine; placebo: saline.
干预措施: Decitabine (Drug)
结局指标
主要结局
Treatment related-adverse events counting
时间窗: 16 weeks
patients will be monitored for any adverse events resulting from the treatment of Human Umbilical Cord Mesenchymal Stem Cells
次要结局
- Improvement in clinical function(16 weeks)