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Inclusion criteria |
(1) 30 to 85 years of age |
(2) Signed informed consent |
(3) Chronic stable ischemic heart disease |
(4) Symptomatic heart failure (NYHA II-III) |
(5) Left ventricle ejection fraction (LVEF) ≤ 45% documented by echocardiography at randomisation obtained after up-titration in heart failure medication (if cardiac resynchronisation therapy device (CRT) 3 months after implantation) |
(6) Plasma NT-pro-BNP > 300 pg/mL (>35 pmol/L) in sinus rhythm and plasma NT-pro-BNP > 422 pg/mL (>49 pmol/L) in patients with atrial fibrillation |
(7) Maximal tolerable heart failure medication |
(8) Heart failure medication unchanged two months prior to inclusion/signature of informed consent. Changes in diuretics accepted |
(9) No option for percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) |
(10) Patients who have had PCI or CABG within six months of inclusion must have a new angiography less than one month before inclusion and at least four months after the intervention to rule out early restenosis |
(11) Patients cannot be included until three months after implantation of a CRT or 1 month after an implantable cardioverter device (ICD) |
Exclusion criteria |
(1) Heart failure (NYHA I or IV) |
(2) Acute coronary syndrome with elevation of CKMB or troponins, stroke, or transitory cerebral ischemia within six weeks of inclusion |
(3) Other revascularization treatment within four months of treatment |
(4) If clinically indicated that the patient should have a coronary angiography before inclusion |
(5) Moderate to severe aortic stenosis (valve area < 1.3 cm2) or valvular disease with option for surgery |
(6) Diminished functional capacity for other reasons such as obstructive pulmonary disease with forced expiratory volume in 1 second (FEV1) < 1 L/min, moderate to severe claudication, severe arthrosis or severe pain from the musculoskeletal system, or morbid obesity |
(7) Clinical significant anaemia (haemoglobin < 6 mmol/L), leukopenia (leucocytes < 2 × 109/L), leucocytosis (leucocytes > 14 × 109/L), or thrombocytopenia (thrombocytes < 50 × 109/L) |
(8) Anticoagulation treatment that cannot be paused during cell injections |
(9) Patients with reduced immune response |
(10) History with malignant disease within five years of inclusion or suspected malignancy, except treated skin cancer other than melanoma |
(11) Pregnancy or lactation |
(12) Other experimental treatment within four weeks of baseline tests |
(13) Participation in another intervention trial |
(14) Known hypersensitivity to dimethyl sulfoxide (DMSO) |
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