Cell Therapy in Chronic Ischemic Heart Disease

January 26, 2010 updated by: Ministry of Health, Brazil

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Intramyocardial Injection of Autologous Bone-Marrow Cells in Patients With Severe, Chronic Ischemic Heart Disease Undergoing Coronary Bypass Surgery

This study was designed to test the hypothesis that direct injection of bone-marrow cells in the heart may increase the number of blood vessels, ameliorating the heart's performance, and relieving patients from symptoms like angina and/or shortness of breath.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Severe ischemic heart disease (IHD) remains a clinical challenge; many patients with IHD have undergone myocardial revascularization procedures (either percutaneous or surgical) but still remain symptomatic despite maximally tolerated medical therapy. Others are considered non-optimal candidates for a complete myocardial revascularization procedure due to the extension and diffuseness of the disease.

Cell therapy with autologous bone marrow-derived cells (BMC) is a novel therapeutic strategy being tested for many cardiovascular diseases, including heart failure, acute myocardial infarction, chronic ischemic heart disease.

The primary objective of this study is to assess the efficacy of intramyocardial injection of autologous BMC on the myocardial perfusion and left ventricular function as an adjunctive therapy (compared to placebo) in patients undergoing coronary artery bypass surgery (CABG).

The secondary objective of this study is to assess the effect of intramyocardial injection of autologous BMC on functional class (angina/heart failure), functional capacity, global and cardiovascular mortality, and quality of life in patients undergoing coronary artery bypass surgery (CABG).

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 3

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
    • PE
      • Recife, PE, Brazil, 52010-040
        • Instituto do Coração de Pernambuco do Real Hospital Português de Beneficência
    • PR
      • Curitiba, PR, Brazil, 80010-030
        • Irmandade da Santa Casa de Misericórdia
      • Curitiba, PR, Brazil, 80320-320
        • Clínica Cardiologyca C. Constantini
    • RJ
      • Rio de Janeiro, RJ, Brazil, 22240-002
        • Instituto Nacional de Cardiologia Laranjeiras (INCL)
      • Rio de Janeiro, RJ, Brazil, 22280-000
        • Hospital Pro-Cardiaco
    • SP
      • São Paulo, SP, Brazil, 05403-900
        • Heart Institute (InCor), Hospital das Clínicas, University of São Paulo Medical School

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

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of chronic, severe, diffuse, multivessel atherosclerotic coronary artery disease (CAD) referred for CABG.
  • Echocardiogram-assessed LVEF between 25 and 55% (Simpson's rule).
  • Angina (or equivalent) functional class II to IV (Canadian Cardiovascular Society) despite maximally tolerated medical therapy.

  • Abnormal myocardial perfusion tests:

    i. Cardiac scintigraphy ii. Magnetic resonance imaging iii. Dobutamine-atropine stress-echocardiogram

  • Non-candidates for a percutaneous coronary intervention (PCI) due to ANY of the following:

    i. High risk lesion ii. Extensive lesion iii. Diffuse, small vessel disease

  • Non-candidates for a complete CABG, or candidates for a complete CABG in whom, according to an expert panel, there is a high probability of failure of the grafts due to the extension and severity of the disease, with diffuse, small vessel involvement.
  • To provide a signed, written informed consent, according to the National Guidelines for Clinical Trials.

Exclusion Criteria:

  • Severe valve heart disease requiring surgical repair.
  • Serologic diagnostic of Chagas' disease.
  • Symptoms of heart failure, even from an ischemic etiology, in the absence of objectively documented myocardial ischemia.
  • Malignant ventricular arrhythmias (like VT), unless an ICD have been placed.
  • Any acute coronary syndrome in the past 3 months.
  • End-stage renal disease requiring maintenance dialysis.
  • History of neoplasia.
  • Drug or alcohol abuse.
  • Life expectancy below 2 years.
  • Enrollment in any cell therapy trial in the past 2 years.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Reduction in the ischemic score (global/regional) at 12 months; increase in left ventricle ejection fraction (LVEF) at 12 months.

Secondary Outcome Measures

Outcome Measure
All-cause and cardiovascular mortality during the first year; increase in VO2max, increase in quality of life, reduction in angina/heart failure functional class at 12 months; percentage of patients with a 5% increase in LVEF at 6 and 12 months.

Collaborators and Investigators

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

Sponsor

Ministry of Health, Brazil

Collaborators

Ministry of Science and Technology

Investigators

  • Principal Investigator: Sergio A. de Oliveira, MD, PhD, Heart Institute (InCor), Hospital das Clínicas, University of São Paulo Medical School
  • Study Director: Jose Eduardo Krieger, MD, PhD, Heart Institute (InCor), Hospital das Clínicas, University of São Paulo Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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, 2006

Primary Completion (Anticipated)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

August 8, 2006

First Submitted That Met QC Criteria

August 8, 2006

First Posted (Estimate)

August 10, 2006

Study Record Updates

Last Update Posted (Estimate)

January 27, 2010

Last Update Submitted That Met QC Criteria

January 26, 2010

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMRTCC-ISQ

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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