Allogeneic Stem Cell Therapy in Heart Failure

The primary objective is to investigate the regenerative capacity of direct intra-myocardial injection of 100 mio. allogeneic CSCC_ASCs in patients with reduced left ventricular Ejection Fraction (EF) (≤45%) and heart failure in a double-blind placebo-controlled design.

A total of 81 patients with will be enrolled in the study and treated in a 2:1 randomization with either CSCC_ASC or placebo (saline).

The primary endpoint is change in left ventricle end-systolic volume (LVESV) at 6 months follow-up.

Inclusion criteria

• 30 to 80 years of age
• Signed informed consent
• Chronic stable ischemic heart disease
• Symptomatic heart failure - New York Heart Association (NYHA) class II-III
• EF ≤45%
• Plasma NT-pro-BNP > 300 pg/ml (> 35 pmol/L) in sinus rhythm and plasma NT-pro-BNP > 422 pg/ml (> 450 pmol/L) in patients with atrial fibrillation
• Maximal tolerable heart failure medication
• Medication unchanged two months prior to inclusion
• No option for percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
• Patients who have had PCI or CABG within six months of inclusion must have a new angiography less than one month before inclusion or at least four months after the intervention to rule out early restenosis
• Patients cannot be included until three months after implantation of a cardiac resynchronisation therapy device

Exclusion criteria

• Heart Failure (NYHA I or IV)
• Acute coronary syndrome with elevation of creatine kinase (CK) isoenzyme MB (CKMB) or troponins, stroke or transitory cerebral ischemia within six weeks of inclusion
• Other revascularisation treatment within four months of treatment
• If clinically indicated the patient should have a coronary angiography before inclusion
• Moderate to severe aortic stenosis (valve area < 1.3 mm2) or valvular disease with option for surgery.
• Diminished functional capacity for other reasons such as: obstructive pulmonary disease (COPD) with forced expiratory volume (FEV) <1 L/min, moderate to severe claudication or morbid obesity
• Clinical significant anaemia (haemoglobin < 6 mmol/L), leukopenia (leucocytes < 2 109/L), leucocytosis (leucocytes >14 109/L) or thrombocytopenia (thrombocytes < 50 109/L)
• Anticoagulation treatment that cannot be paused during cell injections
• Patients with reduced immune response
• History with malignant disease within five years of inclusion or suspected malignity - except treated skin cancer other than melanoma
• Pregnant women
• Other experimental treatment within four weeks of baseline tests
• Participation in another intervention trial