Research for Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-MDS) in the Treatment of Myelodysplastic Syndrome (MDS)

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.

• Allogeneic umbilical cord mesenchymal stem cells (Biological): Experimental group receive Allogeneic umbilical cord mesenchymal stem cell，i.v (SCLnow 19#)
• Decitabine (Drug): Decitabine，20mg/m\^2/d

Primary outcomes

• Treatment related-adverse events counting [16 weeks]: patients will be monitored for any adverse events resulting from the treatment of Human Umbilical Cord Mesenchymal Stem Cells

Secondary outcomes

• Improvement in clinical function [16 weeks]: According to 'Diagnostic and Curative Criteria of Hematological Diseases' 3rd edition edited by Zhang Zhinan and Shen Di, evaluate the hUC-MSCs efficacy. The result as follow: * complete remission (CR); * partial remission (PR); * stable disease (SD); * progressive disease (PD)

Sex: All, ages: 60 Years to 85 Years

Inclusion Criteria:

* MDS patients with international prostate symptom score is moderate or severe symptoms

Exclusion Criteria:

* 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

• Shana Chen, Study director, Inner Mongolia International Mongolian Hospital
• Lei Guo, Study chair, China-Japan Union Hospital, Jilin University