Myocardial Infarction
Conditions
Keywords
Myocardial infarction, Mesenchymal stem cells, Bone marrow, Stem cells transplantation
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).
Interventions
BIOLOGICALBone marrow mesenchymal stem cells transfer
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
DRUGBest medical treatment
Refer to the latest medication guidelines and give the best medication to the patients
PROCEDUREPercutaneous coronary intervention
Percutaneous coronary intervention
Sponsors
Chinese PLA General Hospital
Peking Union Medical College Hospital
Beijing Tongren Hospital
Affiliated Hospital of North Sichuan Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes in myocardial metabolic activity | 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) | Baseline + after 12 months | Changes in left ventricular ejection fraction (LVEF) at 12 months after transplantation of autologous BM-MSCs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence of cardiovascular events | in 12 months after transplantation of autologous BM-MSCs | incidence of cardiovascular events |
| overall mortality | in 12 months after transplantation of autologous BM-MSCs | overall mortality |
| adverse events at 12 months after transplantation of autologous BM-MSCs | in 12 months after transplantation of autologous BM-MSCs | adverse events at 12 months after transplantation of autologous BM-MSCs |
Countries
China
Outcome results
None listed