Cell Therapy in Severe Chronic Ischemic Heart Disease

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

PHASE3

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2018-07-31

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.

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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.

Conditions

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Chronic Ischemic Heart Disease Coronary Artery Disease Angina Pectoris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intramyocardial injection of bone marrow-derived cells OR placebo (saline) during CABG

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cell Therapy

Intramyocardial injection of autologous bone marrow-derived cells

Group Type EXPERIMENTAL

Cell Therapy

Intervention Type PROCEDURE

Intramyocardial injection of autologous bone marrow-derived cells

Placebo

Saline injection

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cell Therapy

Intramyocardial injection of autologous bone marrow-derived cells

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No