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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cardiac stem cell transplantation | Experimental | The patients with heart failure that underwent cardiac stem cell transplantation. |
|
| Placebo | Placebo Comparator | The patients with heart failure that underwent placebo injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intracoronary injection | Biological | stem cell transplantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| death | evaluation the rate of patients mortality after cardiac stem cell transplantation. | 18months |
| arrhythmia | Evaluation rate of arrhythmia after cardiac stem cell transplantation | 18months |
| hospitalization | Evaluation the rate of hospitalization after cardiac stem cell transplantation | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Ejectin fraction changes | evaluation the elevation of ejection fraction in patients after cardiac stem cell transplantation. | 18months |
| Pro BNP changes | Evaluation the reduction of Pro BNP in patients after cardiac stem cell transplantation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nasser Aghdami, MD,PhD | Contact | +9821235622000 | 504 | nasser.aghdami@royaninstitute.org |
| Leila Arab, MD | Contact | +982123562000 | 414 | leila.arab@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Hamid Gourabi, PhD | Head of Royan Institute | Study Chair |
| Nasser Aghdami, MD,PhD | Head of Royan department of degenerative medicine | Study Director |
| Ahmad Amin, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royan Institute | Recruiting | Tehran | Iran |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Intracoronary injection of Placebo | Biological | Injection of Placebo via coronary arteries in patients with heart failure. |
|
| 18months |
| NYHA functional class | Evaluation the improvement of NYHA functional class in patients after cardiac stem cell transplantation. | 18months |
| 6MW test | Evaluation the improvement of 6MW test after cardiac stem cell transplantation. | 18months |
| Department of Heart failure,Shahid Rajaee Hospital |
| Study Director |
| Farveh Vakilian, MD | Department of Heart failure , Imam reza hospital, Mashhad, Iran | Principal Investigator |