Cell Therapy in Severe Chronic Ischemic Heart Disease

Study Overview
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Brief Summary
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Patients with advanced coronary artery disease usually undergo incomplete myocardial revascularization due to the extension and diffuseness of the disease, with very poor distal arterial beds unsuitable for direct revascularization. This study was designed to test the hypothesis that direct, intramyocardial injection of autologous bone marrow cells may further improve myocardial perfusion in patients undergoing incomplete bypass surgery.

Detailed Description
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All eligible patients will undergo coronary artery bypass grafting (CABG) and, in previously identified areas of viable, ischemic myocardium unsuitable for direct revascularization, be randomized to either placebo (saline) or intramyocardial injection of bone marrow-derived cells (BMC) during surgery. During follow-up, myocardial perfusion assessment will be performed to determine the improvement in treated areas compared to non-treated segments.

Official Title
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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

Conditions
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Chronic Ischemic Heart Disease, Coronary Artery Disease, Angina Pectoris

Intervention / Treatment
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* Procedure: Cell Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: symptoms of angina or angina equivalent documented coronary artery disease (invasive angiography) documented myocardial ischemia (stress echo, cardiac scintigraphy, or MRI) unsuitable for complete myocardial revascularization (PCI or CABG) OR even if a complete procedure in feasible, it is anticipated that myocardial perfusion may not be restored due to poor distal beds Exclusion Criteria: severe LV dysfunction (EF < 25% on echo) short life expectacy (below < 1 year) diagnosis of cancer in the past 5 years diagnosis of hematological diseases diagnosis of severe heart disease of other etiologies including valvular heart disease, Chagas' disease, etc) diagnosis of acute coronary syndrome in the past 3 months diagnosis of chronic kidney disease stage V requiring chronic dialysis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intramyocardial injection of bone marrow-derived cells OR placebo (saline) during CABG
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cell Therapy<br>Intramyocardial injection of autologous bone marrow-derived cells | Procedure: Cell Therapy<br>* Intramyocardial injection of autologous bone marrow-derived cells<br>|
| No Intervention: Placebo<br>Saline injection | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in myocardial perfusion | Patients will undergo myocardial perfusion assessment by MRI during pharmacological stress with adenosine or dipyridamole. Alternatively, cardiac scintigraphy can be used in patients with contra-indications to MRI. | 1, 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in LV function | LV function (global and regional) will be assessed by MRI. | 1, 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac surgery, Chronic ischemic heart disease, Coronary artery disease, Angina pectoris, Myocardial ischemia