A Phase 2 interventional study of Intracoronary injection and Intracoronary injection of Placebo in Heart Failure, sponsored by Royan Institute. Status unknown at 1 site in Iran, Islamic Republic of. Open to participants aged 14 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-12-04.
Sponsored by Royan Institute · Phase 2, Interventional, and Treatment
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 50 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Royan Institute is the lead sponsor of 92 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The patients with heart failure that underwent cardiac stem cell transplantation.
Biological: Intracoronary injection
The patients with heart failure that underwent placebo injection.
Biological: Intracoronary injection of Placebo
stem cell transplantation
Also known as: autologous cardiac stem cell intracoronary injection
Injection of Placebo via coronary arteries in patients with heart failure.
death
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
This study is status unknown, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Royan Institute