Retrograde Application of Bone Marrow Aspirate Concentrate

Our assumption is that non-selected BMAC administrations will lead to improvements in the left ventricular ejection fraction (LV EF), the left ventricular end-systolic and end-diastolic diameters and volumes (measured with magnetic resonance imaging) compared to standard heart failure therapy.

Furthermore, it will be associated with improved exercise tolerance in the six-minute corridor walk test and an improvement in the life quality of patients without increasing the incidence of severe ventricular arrythmias.

Inclusion criteria

• Patients with chronic heart failure and left ventricular ejection fraction ≤ 40% with coronary artery disease and with symptoms of heart failure in the NYHA class ≥ 3 on standard heart failure therapy for 3 months and in a stabilised state for at least 1 month
• Age ≥18 years
• Informed, written consent by the patient
• Ability to comply fully with the study protocol
• Negative pregnancy test (and effective contraception) in women with childbearing potential

Exclusion criteria

• Previous bone marrow disease (especially myelodysplastic syndrome or non-Hodgkin's lymphoma)
• Acute myocardial infarction ˂ 1 week
• Active infection or antibiotics treatment ˂ 1 week
• Previous malingant ventricular arrhythmias without cardioverter-defibrilator (ICD) implantation
• Anemia (HTC≤28%), leukocythosis (≥ 14.000/mm3) or thrombocytopenia (≤50.000/mm3)
• Previous bleeding diathesis
• Need for hematopoietic growth factor treatment (e.g. erythropoetin, G-CSF)
• Impossibility of aspiration 240ml of bone marrow
• Hepathopathy or cirrhosis (bilirubin, ALT or AST ≥ 2,5x upper limit of normal)
• Terminal renal insufficiency or haemodyalysis
• Uncontrolled hypertension
• Need for high dose (> 7.5mg/day) corticotherapy within the next 6 months
• Inability to stop anticoagulation therapy (>72 hours) before bone marrow aspiration
• Known malignancies requiring actino or chemotherapy, or previous actinotherapy
• Patients with a BMI >40
• Known allergy to contrast agents
• Other comorbidities with a life expectancy of 6 months