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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Basic medication: Decitabine; Allogeneic umbilical cord mesenchymal stem cells. |
|
| Control group | Placebo Comparator | Basic medication: Decitabine; placebo: saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic umbilical cord mesenchymal stem cells | Biological | Experimental group receive Allogeneic umbilical cord mesenchymal stem cellļ¼i.v (SCLnow 19#) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment related-adverse events counting | patients will be monitored for any adverse events resulting from the treatment of Human Umbilical Cord Mesenchymal Stem Cells | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shana Chen | Inner Mongolia International Mongolian Hospital | Study Director |
| Lei Guo | China-Japan Union Hospital, Jilin University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inner Mongolia International Mongolian Hospital | Hohhot | Inner Mongolia | 010065 | China |
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| Decitabine | Drug | Decitabineļ¼20mg/m^2/d |
|
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000077209 | Decitabine |
| ID | Term |
|---|---|
| D001374 | Azacitidine |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
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