Clinical Study of Hypoxia-Stressed Bone Marrow Mononuclear Cell Transplantation to Treat Heart Diseases (CSHSBMMCTTHD)
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Details and patient eligibility
About
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.
Enrollment
Sex
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
100 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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