Bone Marrow Mesenchymal Stem Cells Transfer in Patients With ST-segment Elevation Myocardial Infarction

Study Overview
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Brief Summary
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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
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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).

Official Title
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Bone Marrow Mesenchymal Stem Cells Transfer in Patients With ST-segment Elevation Myocardial Infarction: Single-blind, Randomized Controlled Muticentre Trial

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Biological: Bone marrow mesenchymal stem cells transfer
* Drug: Best medical treatment
* Procedure: Percutaneous coronary intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BM-MSCs group<br>Receive the best medication, percutaneous coronary intervention, and bone marrow mesenchymal stem cells transfer(Intracoronary artery ) | Biological: Bone marrow mesenchymal stem cells transfer<br>* 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<br>Drug: Best medical treatment<br>* Refer to the latest medication guidelines and give the best medication to the patients<br>Procedure: Percutaneous coronary intervention<br>* Percutaneous coronary intervention<br>|
| Sham Comparator: Control group<br>Receive the best medication, percutaneous coronary intervention | Drug: Best medical treatment<br>* Refer to the latest medication guidelines and give the best medication to the patients<br>Procedure: Percutaneous coronary intervention<br>* Percutaneous coronary intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in myocardial metabolic activity | changes in myocardial metabolic activity 6 months after transplantation of autologous BM-MSCs (SPET assay) | 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. | Baseline + after 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of cardiovascular events | incidence of cardiovascular events | in 12 months after transplantation of autologous BM-MSCs | 
| overall mortality | overall mortality | 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 | in 12 months after transplantation of autologous BM-MSCs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial infarction, Mesenchymal stem cells, Bone marrow, Stem cells transplantation