Therapeutic Outcome of Intracoronary Transplantation of Autologous Cardiac Stem Cells in Patients With Ischemic Heart Failure: Randomized Double Blind Clinical Trial
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Royan Institute
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- arrhythmia
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 14 Years to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
cardiac stem cell transplantation
The patients with heart failure that underwent cardiac stem cell transplantation.
Intervention: Intracoronary injection (Biological)
Placebo
The patients with heart failure that underwent placebo injection.
Intervention: Intracoronary injection of Placebo (Biological)
Outcomes
Primary Outcomes
arrhythmia
Time Frame: 18months
Evaluation rate of arrhythmia after cardiac stem cell transplantation
death
Time Frame: 18months
evaluation the rate of patients mortality after cardiac stem cell transplantation.
hospitalization
Time Frame: 18 months
Evaluation the rate of hospitalization after cardiac stem cell transplantation
Secondary Outcomes
- 6MW test(18months)
- Pro BNP changes(18months)
- NYHA functional class(18months)
- Ejectin fraction changes(18months)