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Mesenchymal Stem Cells to Treat Ischemic Cardiomyopathy

Primary Purpose

Ischemic Cardiomyopathy

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
MSCs injection
Sponsored by
Alexandra Cristina Senegaglia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Cardiomyopathy focused on measuring Cardiovascular Diseases, Myocardial Ischemia, Coronary Artery Disease, Heart Diseases, Coronary Disease, Ventricular Dysfunction, Arteriosclerosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pontifícia Universidade Católica do Paraná

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MSCs injection

Arm Description

Injection of autologous bone marrow-derived mesenchymal cells

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in quality of life
Measures by specific questionnaire of quality of life: Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Changes in exercise capacity
Changes in plasma inflammatory markers

Full Information

First Posted
July 30, 2013
Last Updated
December 11, 2017
Sponsor
Alexandra Cristina Senegaglia
Collaborators
Santa Casa de Misericórdia de Curitiba, Brazil, Fundação Araucária
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1. Study Identification

Unique Protocol Identification Number
NCT01913886
Brief Title
Mesenchymal Stem Cells to Treat Ischemic Cardiomyopathy
Official Title
Autologous Grafting of Mesenchymal Stem Cells in Severe Refractory Ischemic Cardiomyopathy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alexandra Cristina Senegaglia
Collaborators
Santa Casa de Misericórdia de Curitiba, Brazil, Fundação Araucária

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Cardiomyopathy
Keywords
Cardiovascular Diseases, Myocardial Ischemia, Coronary Artery Disease, Heart Diseases, Coronary Disease, Ventricular Dysfunction, Arteriosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MSCs injection
Arm Type
Experimental
Arm Description
Injection of autologous bone marrow-derived mesenchymal cells
Intervention Type
Procedure
Intervention Name(s)
MSCs injection
Intervention Description
MSCs cells will be injected in two aliquots of 10 ml by catheterism
Primary Outcome Measure Information:
Title
Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiogram.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in quality of life
Description
Measures by specific questionnaire of quality of life: Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Time Frame
3 months, 6 months, 12 months
Title
Changes in exercise capacity
Time Frame
1 year
Title
Changes in plasma inflammatory markers
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulo Brofman, PhD
Organizational Affiliation
Pontifícia Universidade Católica do Paraná
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pontifícia Universidade Católica do Paraná
City
Curitiba
State/Province
Paraná
Country
Brazil

12. IPD Sharing Statement

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Mesenchymal Stem Cells to Treat Ischemic Cardiomyopathy

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