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The purposes of the study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSC) in treating heart failure patients
This is a randomized, paralleled study. Patients will be divided into two groups of treatment and control. all of them will receive conventional treatment based on specific condition, including digitalis, milrinone, furosemide, beta-blocker blues, Angiotensin-Converting Enzyme Inhibitors (ACEI), angiotension receptor blocker (ARB), and antiplatelet aggregation etc. Treatment group patients will receive hUC-MSC. Follow-up visit will occur on 3 months, 6 months, and 12 months after the cell transfusion. Vital signs, blood routine test, urine routine test, liver function examination, etc, will be placed to evaluate the safety of hUC-MSC treatment. And the change of symptoms to evaluate the efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | conventional treatment; Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) by i.v. |
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| Control group | Placebo Comparator | Conventional treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) | Biological | Allogeneic umbilical cord mesenchymal stem cells will transfusion by intravenous transplantation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Heart color ultrasound evaluation | Criteria:
| 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Single therapy effectiveness evaluation | Evaluate criteria:
| 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nashundalai | Inner Mongolia International Mongolian Hospital | Study Director |
| Lei Guo, Dr. | 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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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| conventional treatment | Drug | The drug and usage will be determined based on patient's condition, including milrinone, furosemide, beta-blocker blues, Angiotensin-Converting Enzyme Inhibitors (ACEI), angiotension receptor blocker (ARB), or antiplatelet aggregation etc. |
|