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| ID | Type | Description | Link |
|---|---|---|---|
| SFDA2010 | Registry Identifier | State Food and Drug Administration |
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The purpose of this study, is to determine the differences of clinical outcomes between hypoxic pre-treatment group and control group in bone marrow stem cell transplantation (BM-SCT) to treat acute myocardial infarction (AMI); and to evaluate the safety of both treatments. Heart failure patients underwent PCI treatment after AMI and with informed consent, are randomized allocation into hypoxic pre-treated BM-SCT group, normoxic pre-treated BM-SCT group, and control group. Cell resuspension is intracoronary injected into patients receiving coronary angiography, IL-6, CRP, TNF and BNP are detected; echocardiography, cardiac MRI and ECT are analyzed to evaluate heart function and alive myocardial cells. Holter's ECG monitor is employed to observe arrhythmia and embolism. We hypothesize that, by receiving hypoxic pre-treated BM-SCT, impaired heart function will be reversed in heart failure patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMSCs transplantation | Experimental |
| |
| No BMSCs transplantation | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypoxia-stressed BMSCs transplantation to cure MI | Procedure | Experimental group: intracoronary injection of 10^7 BMSCs Sham Comparator: inject the same volume saline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Heart function | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jian'an Wang, M.D, Ph.D | 2nd Affiliated Hospital, School of Medicine at Zhejiang University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18374759 | Background | Hu X, Yu SP, Fraser JL, Lu Z, Ogle ME, Wang JA, Wei L. Transplantation of hypoxia-preconditioned mesenchymal stem cells improves infarcted heart function via enhanced survival of implanted cells and angiogenesis. J Thorac Cardiovasc Surg. 2008 Apr;135(4):799-808. doi: 10.1016/j.jtcvs.2007.07.071. | |
| 25755063 | Derived |
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| Hu X, Huang X, Yang Q, Wang L, Sun J, Zhan H, Lin J, Pu Z, Jiang J, Sun Y, Xiang M, Liu X, Xie X, Yu X, Chen Z, Tse HF, Zhang J, Wang J. Safety and efficacy of intracoronary hypoxia-preconditioned bone marrow mononuclear cell administration for acute myocardial infarction patients: The CHINA-AMI randomized controlled trial. Int J Cardiol. 2015 Apr 1;184:446-451. doi: 10.1016/j.ijcard.2015.02.084. Epub 2015 Feb 25. |
| 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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