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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
43
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
Refer to the latest medication guidelines and give the best medication to the patients
Percutaneous coronary intervention
The Third Hospital of Mianyang
Mianyang, Sichuan, China
changes in myocardial metabolic activity
changes in myocardial metabolic activity 6 months after transplantation of autologous BM-MSCs (SPET assay)
Time frame: 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.
Time frame: Baseline + after 12 months
incidence of cardiovascular events
incidence of cardiovascular events
Time frame: in 12 months after transplantation of autologous BM-MSCs
overall mortality
overall mortality
Time frame: 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
Time frame: in 12 months after transplantation of autologous BM-MSCs
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