| Eligibility |
Inclusion Criteria:
1. Ischemic heart failure not amenable to any type of revascularization procedure
(percutaneous or surgical) as determined by one interventional cardiologist and one
cardiovascular surgeon,
2. Canadian Cardiovascular Society Angina functional class III to IV angina and/or
symptoms of heart failure (NYHA score IIb to IV) under state-of-the-art maximal
medical therapy,
3. Left Ventricular Ejection Fraction between 20% and 45%,
4. Peak V02 = 21 mL/Kg/min,
5. Presence of a reversible perfusion defect = 10% of the left ventricular myocardium (at
least 2 segments over 20) as determined by gated-SPECT, 6.18 years = Age = 75 years,
7.Hemodynamic stability, 8.Ability to accomplish a cardiopulmonary exercise testing, 9.Are
not pregnant and do not plan to become pregnant during the study. Females with childbearing
potential must provide a negative pregnancy test within 1-7 days before intervention and
must be using oral or injectable contraception (non-childbearing potential is defined as
post-menopausal for at least 1 year or surgical sterilization or hysterectomy at least 3
months before study start), 10.A signed consent form that has been approved by the
institutional review board.
Exclusion Criteria:
1. A high-risk acute coronary syndrome (ACS) or a myocardial infarction in the past 3
months,
2. Presence of a documented unstable angina,
3. Left ventricular thrombus, as documented by echocardiography,
4. Evidence of a life-threatening arrhythmia,
5. Presence of any severe mitral valve disease requiring valve replacement or
reconstruction,
6. Presence of a mechanical aortic valve,
7. Presence of stenosis of the aortic valve, graded as =+2 equivalent to an orifice area
of 1,5 cm2 or less,
8. Presence of moderate to severe insufficiency of the aortic valve,
9. A left ventricular wall thickness of <8 mm at the target site for cell injection, as
assessed by 2-D echocardiography and/or cardiac MRI,
10. Have a known, serious radiographic contrast allergy,
11. Contraindications to bone-marrow aspiration,
12. Be an organ transplant recipient,
13. Have liver dysfunction, as evidenced by enzymes (AST,ALT) >3x the upper limits of
normals,
14. Severe renal failure (creatinine plasma levels > 2.5 mg/dl),
15. A bleeding diathesis (defined as an INR greater than 1,5 not because of a reversible
cause, i.e. warfarin),
16. Have an hematologic abnormality without other explanation,
17. Apparent infection (c-reactive protein (CPR)>30 mg/L, fever > 37 °C),
18. An infectious-disease test result positive for human immunodeficiency virus (HIV),
hepatitis B, or hepatitis C, treponema pallidum (VDRL), HTLV 1 and 2,
19. Previous or current documented history of leukemia, myeloproliferative or myeloplastic
disorders,
20. Have a cardiac condition that limits lifespan to <1 y,
21. A history of malignancy in the past 5 years,
22. Have a history of drug or alcoholic abuse within the past 24 months,
23. Be on chronic therapy with immunosuppressants,
24. Pregnant or lactating status,
25. Any condition that, in the judgment of the investigator, would place the patient at
undue risk.
|
