Transplantation of Autologous Cardiac Stem Cells in Ischemic Heart Failure

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Therapeutic Outcome of Intracoronary Transplantation of Autologous Cardiac Stem Cells in Patients With Ischemic Heart Failure: Randomized Double Blind Clinical Trial

Conditions
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Heart Failure

Intervention / Treatment
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* Biological: Intracoronary injection
* Biological: Intracoronary injection of Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1- EF≤40 (by Echocardiography) 2- Not responding to standard therapies for heart failure >1m 3- NYHA class ≥ III 4- Myocardial infarction due to coronary artery atherosclerotic disease 5-An area of regional dysfunction, i.e., hypokinetic, akinetic, or dyskinetic (echocardiography or MRI) 6-No HIV/Viral hepatitis 7-Normal liver function (SGPT < 3 times the upper reference range) 8-No or controlled diabetes (hemoglobin A1C < 8.5%) 9- Ability to provide informed consent and follow-up with protocol procedures Exclusion Criteria: 1 prior ICD placement(<2w)/Sustained ventricular arrhythmias 2-Cardiogenic shock 3- pregnancy and Child-bearing 4- Congenital / valvular heart disease

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cardiac stem cell transplantation<br>The patients with heart failure that underwent cardiac stem cell transplantation. | Biological: Intracoronary injection<br>* stem cell transplantation<br>* Other names: autologous cardiac stem cell intracoronary injection;|
| Placebo Comparator: Placebo<br>The patients with heart failure that underwent placebo injection. | Biological: Intracoronary injection of Placebo<br>* Injection of Placebo via coronary arteries in patients with heart failure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac stem ce heart failure cardiac function intracoronary transplantation