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| Name | Class |
|---|---|
| Chinese PLA General Hospital | OTHER |
| Peking Union Medical College Hospital | OTHER |
| Beijing Tongren Hospital | OTHER |
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To investigate the effect and safety of intracoronary autologous bone morrow mesenchymal stem cells (BM-MSCs) transplantation in patients with ST-segment elevation myocardial infarction（ STEMI） .
To investigate the safety of intra-coronary injection of autologous bone marrow mesenchymal stem cells (BM-MSCs) in patients with ST-segment elevation myocardial infarction and its effect on cardiac function and viable myocardium. We plan to include approximately 40 patients with ST-segment elevation myocardial infarction as a research object, and conduct a randomized, single-blind, parallel-controlled multi-center clinical trial. The patients were randomly divided into a BM-MSCs group and a control group, and were given the best drug treatment and percutaneous coronary intervention (PCI). The primary study endpoint was the change in myocardial metabolic activity 6 months after autologous BM-MSCs transplantation and the change in left ventricular ejection fraction (LVEF) at 12 months; The incidence of adverse events. The above indexes were evaluated by cardiac color echocardiography and single photon emission computed tomography (SPECT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BM-MSCs group | Experimental | Receive the best medication, percutaneous coronary intervention, and bone marrow mesenchymal stem cells transfer(Intracoronary artery ) |
|
| Control group | Sham Comparator | Receive the best medication, percutaneous coronary intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone marrow mesenchymal stem cells transfer | Biological | Inject the BM-MSCs into the infarct-related arterial hypertension through the central cavity of the guide wire balloon catheter under the complete blockage of the target blood vessel. Each time the balloon continues to fill for 2 minutes to block blood flow, then resume perfusion for 2 minutes. The above process is repeated 6 ~ 8 times |
| Measure | Description | Time Frame |
|---|---|---|
| changes in myocardial metabolic activity | changes in myocardial metabolic activity 6 months after transplantation of autologous BM-MSCs (SPET assay) | Baseline + after 6 months |
| Changes in left ventricular ejection fraction (LVEF) | Changes in left ventricular ejection fraction (LVEF) at 12 months after transplantation of autologous BM-MSCs. | Baseline + after 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of cardiovascular events | incidence of cardiovascular events | in 12 months after transplantation of autologous BM-MSCs |
| overall mortality | overall mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Hospital of Mianyang | Mianyang | Sichuan | 0816 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33413636 | Derived | Zhang R, Yu J, Zhang N, Li W, Wang J, Cai G, Chen Y, Yang Y, Liu Z. Bone marrow mesenchymal stem cells transfer in patients with ST-segment elevation myocardial infarction: single-blind, multicenter, randomized controlled trial. Stem Cell Res Ther. 2021 Jan 7;12(1):33. doi: 10.1186/s13287-020-02096-6. |
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Unfortunately, the research data is not shared
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|
| Best medical treatment | Drug | Refer to the latest medication guidelines and give the best medication to the patients |
|
| Percutaneous coronary intervention | Procedure | Percutaneous coronary intervention |
|
| in 12 months after transplantation of autologous BM-MSCs |
| adverse events at 12 months after transplantation of autologous BM-MSCs | adverse events at 12 months after transplantation of autologous BM-MSCs | in 12 months after transplantation of autologous BM-MSCs |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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