Bone Marrow Mesenchymal Stem Cells Transfer in Patients With ST-segment Elevation Myocardial Infarction: Single-blind, Randomized Controlled Muticentre Trial
Overview
- Phase
- Phase 2
- Intervention
- Bone marrow mesenchymal stem cells transfer
- Conditions
- Myocardial Infarction
- Sponsor
- Affiliated Hospital of North Sichuan Medical College
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- changes in myocardial metabolic activity
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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） .
Detailed Description
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).
Investigators
Eligibility Criteria
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
Arms & Interventions
BM-MSCs group
Receive the best medication, percutaneous coronary intervention, and bone marrow mesenchymal stem cells transfer(Intracoronary artery )
Intervention: Bone marrow mesenchymal stem cells transfer
BM-MSCs group
Receive the best medication, percutaneous coronary intervention, and bone marrow mesenchymal stem cells transfer(Intracoronary artery )
Intervention: Best medical treatment
BM-MSCs group
Receive the best medication, percutaneous coronary intervention, and bone marrow mesenchymal stem cells transfer(Intracoronary artery )
Intervention: Percutaneous coronary intervention
Control group
Receive the best medication, percutaneous coronary intervention
Intervention: Best medical treatment
Control group
Receive the best medication, percutaneous coronary intervention
Intervention: Percutaneous coronary intervention
Outcomes
Primary Outcomes
changes in myocardial metabolic activity
Time Frame: Baseline + after 6 months
changes in myocardial metabolic activity 6 months after transplantation of autologous BM-MSCs (SPET assay)
Changes in left ventricular ejection fraction (LVEF)
Time Frame: Baseline + after 12 months
Changes in left ventricular ejection fraction (LVEF) at 12 months after transplantation of autologous BM-MSCs.
Secondary Outcomes
- incidence of cardiovascular events(in 12 months after transplantation of autologous BM-MSCs)
- overall mortality(in 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)