Mesenchymal Stem Cells to Treat Ischemic Cardiomyopathy

Autologous Grafting of Mesenchymal Stem Cells in Severe Refractory Ischemic Cardiomyopathy

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01913886

Enrollment

Registered

2013-08-01

Start date

2010-01-31

Completion date

2016-03-31

Last updated

2017-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Cardiomyopathy

Keywords

Cardiovascular Diseases, Myocardial Ischemia, Coronary Artery Disease, Heart Diseases, Coronary Disease, Ventricular Dysfunction, Arteriosclerosis

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.

Interventions

PROCEDUREMSCs injection

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiogram.	3 months

Secondary

Measure	Time frame	Description
Change in quality of life	3 months, 6 months, 12 months	Measures by specific questionnaire of quality of life: Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Changes in exercise capacity	1 year	—
Changes in plasma inflammatory markers	6 months	—

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026