Autologous Grafting of Mesenchymal Stem Cells in Severe Refractory Ischemic Cardiomyopathy
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Ischemic Cardiomyopathy
- Sponsor
- Alexandra Cristina Senegaglia
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiogram.
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This study will evaluate the safety and efficacy of intracoronary injection of mesenchymal stem cells (MSCs) to repair heart function in patients with myocardial ischemia.
Detailed Description
Ischemic heart disease is a major public health problem in the industrialized and developing world. Current research is focusing on the development of cell-based therapies using stem cells to treat heart failure. Mesenchymal stem cells (MSCs) can differentiate into endothelial cells and participate in the development of new blood vessels in the heart damaged. Therefore, MSCs has shown promise for heart repair. The investigators study will evaluate the safety and efficacy of intracoronary injection of mesenchymal stem cells (MSCs) to repair heart function in patients with myocardial ischemia.
Investigators
Alexandra Cristina Senegaglia
PhD
Pontifícia Universidade Católica do Paraná
Eligibility Criteria
Inclusion Criteria
- •Chronic coronary artery disease
- •NYHA (Heart failure) Class II-IV or Angina pectoris CCS Class III or IV or symptoms consistent with.
- •Ejection fraction between 35% and 55%.
- •Stable medical therapy for at least one month
- •Patients clinically treated with coronary angioplasty with or without intraluminal stent.
- •Patients with surgical revascularization and without the possibility of new invasive intervention.
Exclusion Criteria
- •Human immunodeficiency virus (HIV1-2), HTLV-1 and
- •An active uncontrolled infection.
- •Pregnancy.
- •Mental disability.
- •Terminal illnesses.
- •Valvular heart disease, congenital heart disease or other causes of cardiomyopathy than ischemic.
- •Life perspective by other diseases under 1 year.
- •History of severe arrhythmias
- •Renal dysfunction or against medication
- •Inability to perform cardiac catheterization.
Outcomes
Primary Outcomes
Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiogram.
Time Frame: 3 months
Secondary Outcomes
- Change in quality of life(3 months, 6 months, 12 months)
- Changes in exercise capacity(1 year)
- Changes in plasma inflammatory markers(6 months)