Mesenchymal Stem Cells to Treat Ischemic Cardiomyopathy

Phase 1

Completed

• Conditions: Ischemic Cardiomyopathy
• Interventions: Procedure: MSCs injection

• Registration Number: NCT01913886
• Lead Sponsor: Alexandra Cristina Senegaglia

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2013-07-30
• Study First Submitted QC: 2013-07-31
• Study First Posted: 2013-08-01
• Primary Completion: 2013-09
• Study Completion: 2016-03
• Status Verified: 2016-09
• Last Update Submitted: 2017-12-11
• Last Update Posted: 2017-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MSCs injection	MSCs injection	Injection of autologous bone marrow-derived mesenchymal cells

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pontifícia Universidade Católica do Paraná; 🇧🇷 Curitiba, Paraná, Brazil