Bone Marrow Derived Mononuclear Cells for Ischemic Cardiomyopathy (Alster-Star)

This is an evaluative, monocentric study in patients with chronic ischemic heart disease and left bundle branch block who received an ICD-CRT. It is an early investigation on the safety and effects of a single administration of bone marrow derived mononuclear cells after implantation of an ICD-CRT device as an adjunct to CRT and usual drug treatment.

Inclusion Criteria:

• chronic left ventricular dysfunction (ejection fraction <35 %) in chronic ischemic heart disease and asynchronic contraction with indication for a biventricular stimulation (CRT, chronic resynchronization therapy), who do not have an improvement of >15% of LVEF 3 months after CRT-device implantation
• wall motion dysfunction of any territory
• left bundle branch block
• Patients were on individual optimal treatment for chronic ischemic heart disease with one or a combination of the following drug types: diuretics, ß-blockers, ACE-inhibitors, AT1 blockers and/or lipid lowering agents for at least 30 days before CRT Implantation

Exclusion Criteria:

• patients with left ventricular dysfunction due to other reasons than ischemic cardiomyopathy, e.g. hypertension, dilatative cardiomyopathy
• with relevant valvular disease;
• Aneurysma of the anterior myocardial wall or myocardial wall thickness of < 5 mm,
• with overt heart failure, other than ischemic cardiomyopathy,
• with history of stroke and/or transient ischemic attack (TIA),
• with history of thromboembolic event (e.g. phlebothrombosis, pulmonary embolism), bleeding disorders and known disease of the coagulation system;
• with extensive deviations of baseline laboratory values and significant findings at physical examination which in the opinion of the investigator may worsen under treatment;
• with severe systemic disease - (e.g. known or suspected anaphylaxia, intolerance against X-ray or contrast agent and, pre-malignant and malignant disease)
• atrial fibrillation with average heart rate >70 bpm
• pregnant women and women of childbearing potential who have not had a negative pregnancy test within 48 hours before treatment;
• with any disease or condition that seriously compromises the function of other body systems than the heart and/or might interfere with conduct of the study and interpretation of the results;
• patients with a chronic or acute HIV-, HBV-, HCV-infection;
• improvement of more than 15% of LVEF 3 months after CRT-device implantation
• patients who have a ICD Implantation for secondary prophylactic indication. These patients show a history of resuscitation, VT or syncope.
• patients who are currently participating in another investigational drug or device study