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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Experimental group receive Allogeneic umbilical cord mesenchymal stem cell，i.v (SCLnow 19#)
Decitabine，20mg/m\^2/d
Inner Mongolia International Mongolian Hospital
Hohhot, Inner Mongolia, China
Treatment related-adverse events counting
patients will be monitored for any adverse events resulting from the treatment of Human Umbilical Cord Mesenchymal Stem Cells
Time frame: 16 weeks
Improvement in clinical function
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)
Time frame: 16 weeks
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