Trial Information

Summary: This study is for patients with chronic heart damage and no other reasonable treatment options for improving the blood flow to their heart muscle.

Study description / Qualifying patients will have baseline studies of their general health, heart and ability to exercise. The patients will then be randomized to treatment or control arms, where the cardiologist and the patient do not know whether the patient received cells or not. Control patients will have the opportunity to cross over and receive treatment after 6 months.. Then they will be brought into the hospital to have bone marrow collected from their hip bone while they are sedated. The bone marrow cells will be specially processed to purify the patient’s own stem cells identified by a natural enzyme, aldehyde dehydrogenase. The day after the cells are collected they will be injected into areas of the patient’s heart muscle that need to be strengthened using a special injection cardiac catheter. The catheter will also provide a map of how the heart is functioning so the cardiologist can see the strong and weak spots. The patient will then be followed with periodic non-invasive tests like walking on a treadmill and answering questionnaires several times over the following 6 months. At the end of the study the patient will have another heart mapping procedure using a catheter like the one at the beginning of the study. If the patient was a control, this will be their opportunity for treatment. The mapping procedure will be looking for improvement in heart function.

To be considered eligible to participate in this study, the patient must have the following conditions:

• Canadian Cardiovascular Society Angina functional class II to IV angina and/or symptoms of heart failure.
• An ejection fraction of =45%.
• A reversible perfusion defect on single-photon-emission computed tomography (SPECT).
• Coronary artery disease not amenable to any type of revascularization procedure (percutaneous or surgical) in the target area as determined by one interventional cardiologist and one cardiovascular surgeon.
• Hemodynamic stability.
• Ability to walk on a treadmill.
• A signed consent form that has been approved by the institutional review board.

Patients will be excluded from the study if they have any of the following conditions:

• Age <18 or >70 years.
• Atrial fibrillation.
• Left ventricular thrombus, as documented by echocardiography or left ventricular angiography.
• A vascular anatomy that precludes cardiac catheterization.
• Severe valvular disease.
• Pregnant or lactating status.
• A bleeding diathesis (defined as an INR greater than 2.0 in the absence of warfarin therapy).
• An infectious-disease test result positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
• A history of malignancy in the past 5 years.
• Any condition that, in the judgment of the investigator, would place the patient at undue risk.
• A high-risk acute coronary syndrome (ACS) or a myocardial infarction in the past month. (ACS is defined as the presence of chest pain characteristic for angina, dynamic electrocardiography changes such as ST segment depression and/or serum elevation of troponin I < 3X above ULN according to local laboratory..
• A left ventricular wall thickness of <8 mm at the target site for cell injection.

For more information,

If you would like to learn more about participating in this study, please send an e-mail message using the form below.