Cell Therapy and Myocardial Recovery in Heart Failure Patients Undergoing Left Ventricular Assist Device Support

A regiszterben nem jelölt feltételek

• Patient inclusion criteria will consist of all of the following:
• non-ischemic dilated cardiomyopathy
• patient accepted for LVAD support
• optimal (or maximal tolerable therapy) heart failure ≥ 2 months
• age 18-65 years
• ability to provide informed consent
  • Patient exclusion criteria will consist of any of the following:
• ischemic cardiomyopathy
• Cardiomyopathy with a reversible cause that has not been treated e.g. thyroid disease, alcohol abuse, hypophosphataemia, hypocalcaemia, cocaine abuse, selenium toxicity \& chronic uncontrolled tachycardia.
• Cardiomyopathy in association with a neuromuscular disorder e.g. Duchenne's progressive muscular dystrophy.
• ongoing or recent (less than 1 month) infection
• acute multi-organ failure
• clinically significant anemia (Hb < 10 g/dL)
• clinically significant leukopenia (L < 2 x 109/L) or leukocytosis (L > 14 x 109/L)
• clinically significant thrombocytopenia (TRC < 50 x 109/L)
• known disorders of hemostasis that can not be corrected
• history of any thromboembolic complications
• chronic kidney disease (higher than stage III)
• chronic liver disease (Child B or C)
• diminished functional capacity for other reasons such as COPD, moderate or severe claudications, severe musculosceletal system pain or morbid obesity (BMI > 35 kg/m2)
• aortic stenosis (AVA < 1.3 cm2) or ocluded aortic valve
• artificial (mechanical or biological) aortic valve
• patients with reduced immune response
• history of limphoprolipherative disorders or malignancy within 5 years
• left ventricular thrombus
• participation in another interventional clinical trial
• life expectancy less than 12 months
• known hypersensitivity to DMSO, penicillin or streptomycin