Mesenchymal Stem Cells to Treat Ischemic Cardiomyopathy

December 11, 2017 updated by: Alexandra Cristina Senegaglia

Autologous Grafting of Mesenchymal Stem Cells in Severe Refractory Ischemic Cardiomyopathy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Paraná
      • Curitiba, Paraná, Brazil
        • Pontificia Universidade Catolica do Parana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiogram.
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 months, 6 months, 12 months
Changes in exercise capacity
Time Frame: 1 year
1 year
Changes in plasma inflammatory markers
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandra Cristina Senegaglia

Collaborators

Fundação Araucária
Santa Casa de Misericórdia de Curitiba, Brazil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

July 30, 2013

First Submitted That Met QC Criteria

July 31, 2013

First Posted (Estimate)

August 1, 2013

Study Record Updates

Last Update Posted (Actual)

December 13, 2017

Last Update Submitted That Met QC Criteria

December 11, 2017

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSC_Isquemica

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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