This study is a prospective, randomized, double blind , controlled trial to assess the efficacy of intracoronary transplantation of autologous cardiac stem cells in 50 patients with ischemic heart failure.
Heart failure is a common, costly, disabling, and potentially deadly condition. Heart transplantation is the ultimate approach to treating heart failure, but this is costly and excludes patients who are poor candidates for transplantation given their co morbidities, or for whom a donor organ is unavailable. Currently, there is no effective intervention to regenerate dead heart muscle after a heart attack. Our hypothesis is that CSCs regenerates myocardium. In this study all eligible patients are randomly allocated into two study groups by a permuted block randomization method: group A (case group) received 5-10 millions autologous cardiac stem cells, group B (control group) just received placebo. They follow up for 18 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
stem cell transplantation
Injection of Placebo via coronary arteries in patients with heart failure.
Royan Institute
Tehran, Iran
RECRUITINGdeath
evaluation the rate of patients mortality after cardiac stem cell transplantation.
Time frame: 18months
arrhythmia
Evaluation rate of arrhythmia after cardiac stem cell transplantation
Time frame: 18months
hospitalization
Evaluation the rate of hospitalization after cardiac stem cell transplantation
Time frame: 18 months
Ejectin fraction changes
evaluation the elevation of ejection fraction in patients after cardiac stem cell transplantation.
Time frame: 18months
Pro BNP changes
Evaluation the reduction of Pro BNP in patients after cardiac stem cell transplantation.
Time frame: 18months
NYHA functional class
Evaluation the improvement of NYHA functional class in patients after cardiac stem cell transplantation.
Time frame: 18months
6MW test
Evaluation the improvement of 6MW test after cardiac stem cell transplantation.
Time frame: 18months
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