Mesenchymal Stem Cells to Treat Ischemic Cardiomyopathy

Ischemic Cardiomyopathy Clinical Trial

Official title:

Autologous Grafting of Mesenchymal Stem Cells in Severe Refractory Ischemic Cardiomyopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01913886
• Other study ID #: MSC_Isquemica
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 30, 2013
• Last updated: December 11, 2017
• Start date: January 2010
• Est. completion date: March 2016

Study information

• Verified date: September 2016
• Source: Pontifícia Universidade Católica do Paraná
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2016
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Ischemia
• Ischemic Cardiomyopathy

Intervention

Procedure:
• MSCs injection
MSCs cells will be injected in two aliquots of 10 ml by catheterism

Locations

Country	Name	City	State
Brazil	Pontifícia Universidade Católica do Paraná	Curitiba	Paraná

Sponsors (3)

Lead Sponsor	Collaborator
Alexandra Cristina Senegaglia	Fundação Araucária, Santa Casa de Misericórdia de Curitiba, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiogram.		3 months
Secondary	Change in quality of life	Measures by specific questionnaire of quality of life: Minnesota Living with Heart Failure Questionnaire (MLHFQ)	3 months, 6 months, 12 months
Secondary	Changes in exercise capacity		1 year
Secondary	Changes in plasma inflammatory markers		6 months