Abstract 18349: A Pilot Study to Evaluate the Feasibility and Safety of Transendocardial CD34+ Cell Therapy in Heart Failure With Preserved Ejection Fraction
Introduction: To date, no clinical trials of cell therapy in heart failure with preserved ejection fraction (HFpEF) have been performed.
Hypothesis: We sought to investigate the safety and feasibility of transendocardial CD34+ cell therapy in patients with HFpEF.
Methods: In a pilot study, we enrolled 8 patients with HFpEF (LVEF>50%, E/e’>15, NYHA III, NTproBNP levels >300 pg/ml). At baseline, all patients received granulocyte-colony stimulating factor (G-CSF; 10 mcg/kg, 5 days); CD34+ cells were collected by apheresis. We performed electroanatomical mapping of the left ventricle and assessed local diastolic function by measuring local ventricular relaxation times at each of the sampling points. CD34+ cells were then injected transendocardially in the areas of diastolic dysfunction. Each patient received a dose of 80 million CD34+ cells divided into 20 injections; patients were followed for 1 month.
Results: We enrolled 4 male and 4 female patients with a mean age of 61±9 years, creatinine of 0.95±0.25 mg/dl, and total bilirubin of 0.95±0.25 mg/dl. In all patients, electroanatomical mapping consisting of at least 150 sampling points was performed without any adverse events, and we were able to measure local diastolic function and identify target areas for cell delivery in every patient. During cell injections, we encountered 1 episode of sustained ventricular tachycardia that required cardioversion. At 1 month, we found a significant improvement in diastolic function measured by E/e’ (from 20.7±7.4 to 17.1±6.5, P=0.01), a trend towards a decrease in NTproBNP (from 1299±906 pg/ml to 921±763 pg/ml, P=0.24), and a trend of increase in 6-minute walk test distance (from 367±87 m to 412±92 m, P=0.31).
Conclusions: In patients with HFpEF, transendocardial CD34+ cell therapy is feasible and safe, and appears to be associated with improved diastolic function. Further studies are warranted to verify these findings and to define the efficacy of this treatment approach in a broader population of HFpEF patients.
Author Disclosures: B. Vrtovec: None. G. Poglajen: None. G. Zemljic: None. M. Sever: None. M. Cukjati: None. S. Frljak: None. A. Cerar: None. R. Okrajsek: None. P. Cernelc: None. F. Haddad: None. J.C. Wu: None.
- © 2016 by American Heart Association, Inc.