The study compares two different delivery routes of stem cells in patients with chronic ischemic cardiomyopathy. Ischemic means not enough blood and oxygen. Cardio means heart and myopathy muscle-related disease. Patients in the study suffer from loss of contractile force. CD133pos autologous stem cells are a particularly prepared subpopulation of stem cells implemented in order to support cardiac restoration.

Conditions: Patients with chronic ischemic cardiomyopathy with an LVEF =45% and symptomatic heart failure NYHA = II under optimal therapy and drug treatment according to the current ESC heart failure guidelines.
MedDRA version: 14.1Level: LLTClassification code 10019279Term: Heart failureSystem Organ Class: 100000004849
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2009-013103-63-DE

Lead Sponsor: Asklepios Kliniken Hamburg GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 64

Inclusion Criteria

• Patients 18 to 80 years old
• of female and male gender
• Patient has reduced ejection fraction as evaluated by routine clinical angiogramm,
echocardiography or MRI (=45%) due to ischemic heart disease
• symptomatic heart failure NYHA = II on optimal therapy
• coronary artery in the target region that can be used for cell infusion
• Patient has been informed of the nature of the clinical trial and agrees to its provision and
has provided written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• planned or performed CABG surgery or PCI within 4 weeks of study entry
• recent myocardial infarction (< 6 months)
• TIMI flow < II in the coronary artery selected for infusion
• cardiogenic shock requiring mechanical ventilation or intra-aortic balloon pump
• progressive tumor disease
• primary disease of bone marrow including mal-function of components of the coagulation
system
• women of child-bearing age premenopausal
• LV wall thickness < 5mm at planned site of injection
• ventricular wall thrombus
• severe aortic valvular heart disease
• severe atrial or ventricular tachycardia unresponsive to intravenous or oral drug therapy
• aneurysm of the anterior wall
• history of stroke
• know diseases of the liver resulting in reduced plasmatic coagulation with spontaneous INR
>2
• patients with chronic infectious diseases (HBV, HCV, HIV)
• patients taking part or have taken part in other clinical trials within the past 3 months
• patients unable to provide informed consent
• any other medical condition that the enrolling physician deems significant in representing a
potential hazard for the patient when participating in this study