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| Name | Class |
|---|---|
| Shanghai Jiao Tong University Affiliated Sixth People's Hospital | OTHER |
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A pilot study to evaluate the safety and feasibility of umbilical cord mesenchymal stem cells in the treatment of acute myocardial infarction by catheter transplantation
In this study, 40 patients with cardiac insufficiency after acute myocardial infarction were selected and randomly divided into umbilical cord MSCs transplantation treatment group and non-intervention control group to preliminarily observe the safety and effectiveness of MSCs cell transplantation treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UC-MSC | Experimental | UC-MSC transplantation |
|
| Control Group | Placebo Comparator | Routine treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UC-MSC | Biological | 0.25ml Shanghai Life UC-MSC injection is resuspended into 10ml of cell suspension and slowly infused into infarct-related blood vessels through an administration catheter in 2 minutes, and the number of cells transplanted each time is 5x10(6) cells. The UC-MSC products are manufactured by Shanghai Life with viability>80%, and endotoxin<0.1 EU, at the concentration of 2x10(7) cells/ml. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety measured as the number of Major Adverse Cardiac Events (MACE) | Possible adverse events, including adverse events that may occur during angiography and infusion of transplanted cells such as chest pain, arrhythmia, slow blood flow, myocardial injury, fever, allergic reaction, postoperative infection, etc. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in left ventricular ejection fraction measured by magnetic resonance imaging at baseline and 12 months follow-up | left ventricular ejection fraction measured by magnetic resonance imaging | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chengxing Shen, Dr. | Shanghai Jiao Tong University Affiliated Sixth People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Jiao Tong University Affiliated Sixth People's Hospital | Shanghai | Shanghai Municipality | 200233 | China |
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| ID | Term |
|---|---|
| D018487 | Ventricular Dysfunction, Left |
| ID | Term |
|---|---|
| D018754 | Ventricular Dysfunction |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Control Group | Biological | Routine treatment without catheter infusion |
|
| D008722 | Methods |