Cell Therapy in Chronic Ischemic Heart Disease

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00362388
• Other study ID #: EMRTCC-ISQ
• Status: Terminated
• Phase: Phase 3
• First received: August 8, 2006
• Last updated: January 26, 2010
• Start date: January 2006
• Est. completion date: November 2008

Study information

• Verified date: November 2008
• Source: Ministry of Health, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in ResearchBrazil: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 300
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Ischemia
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Procedure:
• Intramyocardial injection of autologous bone marrow cells

Locations

Country	Name	City	State
Brazil	Clínica Cardiologyca C. Constantini	Curitiba	PR
Brazil	Irmandade da Santa Casa de Misericórdia	Curitiba	PR
Brazil	Instituto do Coração de Pernambuco do Real Hospital Português de Beneficência	Recife	PE
Brazil	Hospital Pró-Cardíaco	Rio de Janeiro	RJ
Brazil	Instituto Nacional de Cardiologia Laranjeiras (INCL)	Rio de Janeiro	RJ
Brazil	Heart Institute (InCor), Hospital das Clínicas, University of São Paulo Medical School	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Ministry of Health, Brazil	Ministry of Science and Technology

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in the ischemic score (global/regional) at 12 months; increase in left ventricle ejection fraction (LVEF) at 12 months.
Secondary	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.

External Links

•   Link to the Heart Institute (InCor), in São Paulo, Brazil (in Portuguese).
•   Link to the Instituto Nacional de Cardiologia Laranjeiras (INCL), in Rio de Janeiro, Brazil (In Portuguese).