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Mesenchymal Stem Cells to Treat Ischemic Cardiomyopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01913886
Recruitment Status : Completed
First Posted : August 1, 2013
Last Update Posted : December 13, 2017
Sponsor:
Collaborators:
Santa Casa de Misericórdia de Curitiba, Brazil
Fundação Araucária
Information provided by (Responsible Party):
Alexandra Cristina Senegaglia, Pontifícia Universidade Católica do Paraná

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ischemic Cardiomyopathy Procedure: MSCs injection Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Grafting of Mesenchymal Stem Cells in Severe Refractory Ischemic Cardiomyopathy
Study Start Date : January 2010
Actual Primary Completion Date : September 2013
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Arms and Interventions
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Arm Intervention/treatment
Experimental: MSCs injection
Injection of autologous bone marrow-derived mesenchymal cells
 Procedure: MSCs injection
MSCs cells will be injected in two aliquots of 10 ml by catheterism


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiogram. [ Time Frame: 3 months ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01913886


Locations
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Brazil
Pontifícia Universidade Católica do Paraná
Curitiba, Paraná, Brazil
Sponsors and Collaborators
Alexandra Cristina Senegaglia
Santa Casa de Misericórdia de Curitiba, Brazil
Fundação Araucária
Investigators
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Principal Investigator: Paulo Brofman, PhD Pontifícia Universidade Católica do Paraná
More Information
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Responsible Party: Alexandra Cristina Senegaglia, PhD, Pontifícia Universidade Católica do Paraná
ClinicalTrials.gov Identifier: NCT01913886    
Other Study ID Numbers: MSC_Isquemica
First Posted: August 1, 2013    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: September 2016
Keywords provided by Alexandra Cristina Senegaglia, Pontifícia Universidade Católica do Paraná:
Cardiovascular Diseases
Myocardial Ischemia
Coronary Artery Disease
Heart Diseases
 Coronary Disease
Ventricular Dysfunction
Arteriosclerosis
Additional relevant MeSH terms:
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Cardiomyopathies
Ischemia
Pathologic Processes
Heart Diseases
Cardiovascular Diseases