Acute Myocardial Infarction
Conditions
Keywords
Mesenchymal stem cells, Myocardial infarction, Left ventricular dysfunction
Brief summary
Early reperfusion strategies in tandem with remarkable advances in drugs and devices for treating myocardial infarction (MI) have contributed to a reduction in early mortality, but cardiovascular disease remains the leading cause of death worldwide. Current management strategies cannot solve the problem of cardiomyocyte loss and consequent progression of heart failure. In this respect, stem-cell therapy has shown potential benefits for repairing the damaged myocardium. Mesenchymal stem cells (MSCs) have been considered to be attractive therapeutic candidates because of their high capacity for replication: paracrine effect: ability to preserve potency: and because they do not cause adverse reactions to allogeneic versus autologous transplants. Intracoronary injection of stem cells seems to be safe, but only one clinical trial using MSCs via the intracoronary route in the setting of acute myocardial infarction (AMI) has been carried out. The investigators therefore assessed the safety and efficacy of intracoronary autologous bone marrow (BM)-derived human MSCs in patients with AMI.
Interventions
DRUGMesenchymal stem cell
Route : intracoronary injection Frequency : single dose of autologous bone-marrow derived mesenchymal stem cells Dosage : 1x1000000 cells/kg Duration : mean injection duration approximately 4 weeks after primary percutaneous coronary intervention
DRUGControl group
No additional treatment of mesenchymal stem cells
Sponsors
FCB-Pharmicell Co Ltd.
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* aged 18-70 years * ischemic chest pain for \>30 min * admitted to hospital \<24 h after the onset of chest pain * electrocardiography showed ST segment elevation \>1 mm in two consecutive leads in the limb leads or \>2 mm in the precordial leads * they could be enrolled in the study \<72 h after successful revascularization
Exclusion criteria
* cardiogenic shock (defined as systolic blood pressure \<90 mmHg requiring intravenous pressors or intra-aortic balloon counterpulsation) * life-threatening arrhythmia * impossible conditions for cardiac catheterization * advanced renal or hepatic dysfunction * history of previous coronary artery bypass graft * history of hematologic disease * history of malignancy * major bleeding requiring blood transfusion * stroke or transient ischemic attack in the previous 6 months * structural abnormalities of the central nervous system (brain tumor, aneurysm, history of surgery) * traumatic injury after myocardial infarction * use of corticosteroids or antibiotics during the previous month * major surgical procedure in the previous 3 months * cardiopulmonary resuscitation for \>10 min within the previous 2 weeks * positive skin test for penicillin * positive result for viral markers (human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) and Venereal Disease Research Laboratory (VDRL) test) * pregnancy, possible candidate for pregnancy or breastfeeding females * drug abusers * inappropriate patients to participate in the study according to the chief investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute changes in global LVEF by SPECT | baseline and 6 months | Absolute changes in global left ventricular ejection fraction (LVEF) as measured by SPECT 6 months after cell infusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in left ventricular end-diastolic volume (LVEDV) | baseline and 6 months | — |
| Changes in left ventricular end-systolic volume (LVESV) | baseline and 6 months | — |
| Changes in regional wall motion score index (WMSI) by Echocardiography | baseline and 6 months | — |
| Major adverse cardiac event (MACE) | 6 months | MACE was defined as the composites of any cause of death, myocardial infarction, revascularization of the target vessel, re-hospitalization for heart failure, and life-threatening arrhythmia. |
Countries
South Korea
Outcome results
None listed