Myocardial Infarction (MI) or Acute Myocardial Infarction (AMI)
Conditions
Brief summary
The purpose of this study, is to determine the differences of clinical outcomes between hypoxic pre-treatment group and control group in bone marrow stem cell transplantation (BM-SCT) to treat acute myocardial infarction (AMI); and to evaluate the safety of both treatments. Heart failure patients underwent PCI treatment after AMI and with informed consent, are randomized allocation into hypoxic pre-treated BM-SCT group, normoxic pre-treated BM-SCT group, and control group. Cell resuspension is intracoronary injected into patients receiving coronary angiography, IL-6, CRP, TNF and BNP are detected; echocardiography, cardiac MRI and ECT are analyzed to evaluate heart function and alive myocardial cells. Holter's ECG monitor is employed to observe arrhythmia and embolism. We hypothesize that, by receiving hypoxic pre-treated BM-SCT, impaired heart function will be reversed in heart failure patients.
Interventions
PROCEDUREHypoxia-stressed BMSCs transplantation to cure MI
Experimental group: intracoronary injection of 10\^7 BMSCs Sham Comparator: inject the same volume saline
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of acute Myocardial Infarction(within one month); * Age under 65; * Infarction related wall motion abnormality on echocardiography; * Infarction related TIMI flow grades 3 on coronary angiography during cell injection; * Informed consent;
Exclusion criteria
* Active infection, or hematopoietic malignancy; * Patients have tumor or other lethal diseases; * Informed refusal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Heart function | one year |
Outcome results
None listed