Status:
COMPLETED
Mesenchymal Stem Cells to Treat Ischemic Cardiomyopathy
Lead Sponsor:
Alexandra Cristina Senegaglia
Collaborating Sponsors:
Santa Casa de Misericórdia de Curitiba, Brazil
Fundação Araucária
Conditions:
Ischemic Cardiomyopathy
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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 he...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01913886
Start Date
January 1 2010
End Date
March 1 2016
Last Update
December 13 2017
Active Locations (1)
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1
Pontifícia Universidade Católica do Paraná
Curitiba, Paraná, Brazil