Bone Marrow Mesenchymal Stem Cells Transfer in Patients With ST-segment Elevation Myocardial Infarction
Bone Marrow Mesenchymal Stem Cells Transfer in Patients With ST-segment Elevation Myocardial Infarction: Single-blind, Randomized Controlled Muticentre Trial
PhasePhase 2/Phase 3
Lead SponsorNorth Sichuan Medical University
StatusCompleted No Results Posted
Intervention/TreatmentBone marrow mesenchymal stem cells transfer ...
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).
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
Receive the best medication, percutaneous coronary intervention, and bone marrow mesenchymal stem cells transfer(Intracoronary artery )
Receive the best medication, percutaneous coronary intervention
Inclusion Criteria: Age> 18 years old; Diagnosed acute ST-elevation myocardial infarction (STEMI) STEMI onset <1 month Successful vascular remodeling, blood flow of infarct-related blood vessels recovered to TIMI level 3 All patients included in the study signed an informed consent form and promised to complete all follow-up plans Exclusion Criteria: Refractory persistent ventricular tachycardia High cardiac block and no pacemaker control Liver or renal dysfunction (ALT>80U/ L, Cr> 440mmol / L) Bleeding disorders, malignant tumors Autoimmune disease or any serious fatal disease Contraindications for coronary intervention Combined with other heart disease: congenital heart Disease (ventricular deficiency, atrial deficient, patent ductus arteriosus and other congenital alformations),primary valvular disease, active myocarditis, pulmonary heart disease,hyperthyroidism, mucous edema heart disease and so on Mental illness, no self-awareness, and no precise expression and cooperation