Cell Therapy in HFpEF
Cell Therapy in HFpEF
The primary objective of the study is to investigate safety and efficacy of transendocardial
 CD34+ cell therapy in patients with HFpEF by evaluating changes in myocardial structure and
 function, patient exercise capacity and clinical outcome.

 The safety end-points include serious adverse events (SAEs), defined as any serious event
 that may result in persistent or significant disability or incapacity and included death,
 heart transplantation, sustained ventricular arrhythmia (ventricular tachycardia or
 ventricular fibrillation), and heart failure exacerbation requiring hospitalization.
In all patients, peripheral blood stem cells will be mobilized by daily subcutaneous
 injections of G-CSF (10 mcg/kg, divided b.i.d) for 5 days. Peripheral blood stem cells will
 then be collected with Miltenyi cell separator (Miltenyi Biotech, Germany) and the magnetic
 cell separator Isolex 300i (Nexell Therapeutics Inc., California, USA) will be used for the
 immunomagnetic positive selection of the CD34+ cells.
Inclusion Criteria:

 -  Preserved left ventricular systolic function on echocardiography (LVEF>50%)

 -  Evidence of diastolic dysfunction by echocardiography (E/e'>15)

 -  Symptoms of heart failure

 -  NT-proBNP levels >300 pg/ml

 -  absence of permanent atrial fibrillation

 Exclusion Criteria:

 -  acute multi-organ failure

 -  history of any malignant disease within 5 years

 -  diminished functional capacity due to non-cardiac co-morbidities (COPD, PAOD, morbid
 obesity)

 -  pregnancy