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Mesenchymal Stem Cells to Treat Ischemic Cardiomyopathy

NCT ID: NCT01913886

Last Updated: 2017-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2016-03-31

Brief Summary

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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

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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.

Conditions

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Ischemic Cardiomyopathy

Keywords

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Cardiovascular Diseases Myocardial Ischemia Coronary Artery Disease Heart Diseases Coronary Disease Ventricular Dysfunction Arteriosclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MSCs injection

Injection of autologous bone marrow-derived mesenchymal cells

Group Type EXPERIMENTAL

MSCs injection

Intervention Type PROCEDURE

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

Interventions

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MSCs injection

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Santa Casa de Misericórdia de Curitiba, Brazil

UNKNOWN

Sponsor Role collaborator

Fundação Araucária

OTHER

Sponsor Role collaborator

Alexandra Cristina Senegaglia

OTHER

Sponsor Role lead

Responsible Party

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Alexandra Cristina Senegaglia

PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Paulo Brofman, PhD

Role: PRINCIPAL_INVESTIGATOR

Pontifícia Universidade Católica do Paraná

Locations

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Pontifícia Universidade Católica do Paraná

Curitiba, Paraná, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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MSC_Isquemica

Identifier Type: -

Identifier Source: org_study_id