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Completed

NCT Number: NCT01913886

Mesenchymal Stem Cells to Treat Ischemic Cardiomyopathy

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.

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Key information

Conditions

Ischemic Cardiomyopathy Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases Ventricular Dysfunction

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Pontifícia Universidade Católica do Paraná

Curitiba, Paraná, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MSCs injection

Procedure

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

Primary outcomes

  1. Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiogram.

    Time frame: 3 months

Secondary outcomes

  1. Change in quality of life

    Time frame: 3 months, 6 months, 12 months

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

  2. Changes in exercise capacity

    Time frame: 1 year

  3. Changes in plasma inflammatory markers

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Alexandra Cristina Senegaglia

Other

Collaborators

  • Fundação Araucária
  • Santa Casa de Misericórdia de Curitiba, Brazil

Registry information

Official study title

Autologous Grafting of Mesenchymal Stem Cells in Severe Refractory Ischemic Cardiomyopathy

Important dates

Study start
2010
Primary completion
2013
Study completion
2016
First posted
Aug 1, 2013
Registry last updated
Dec 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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