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

Research for Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Myelodysplastic Syndrome (MDS)

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.

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