Mesenchymal Stem Cells to Treat Ischemic Cardiomyopathy

Phase 2CompletedNCT01913886

Alexandra Cristina Senegaglia10 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ischemic Cardiomyopathy

Interventions

MSCs injectionPROCEDURE

MSCs cells will be injected in two aliquots of 10 ml by catheterism

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 2. * 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.

Locations (1)

Pontifícia Universidade Católica do Paraná

Curitiba, Paraná, Brazil

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

Measures by specific questionnaire of quality of life: Minnesota Living with Heart Failure Questionnaire (MLHFQ)

Time frame: 3 months, 6 months, 12 months

Changes in exercise capacity

Time frame: 1 year

Changes in plasma inflammatory markers

Time frame: 6 months

Data from ClinicalTrials.gov

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