Abstract 18309: The Effects of Repetitive Transendocardial CD34+ Cell Therapy in Dilated Cardiomyopathy Patients
Introduction: The clinical effects of repetitive cell therapy in heart failure have not been studied yet.
Hypothesis: We investigated whether repetitive administration of CD34+ cells is superior to single administration in patients with non-ischemic dilated cardiomyopathy (DCM).
Methods: In a prospective study, we enrolled 60 patients with DCM, NYHA 3 and LVEF<40% who were randomly allocated to repetitive cell therapy (Group A, N=30), or single cell therapy (Group B, N=30). At baseline, all patients received granulocyte-colony stimulating factor (G-CSF; 10 mcg/kg, 5 days); CD34+ cells were collected by apheresis and injected transendocardially. Each patient received a dose of 80 million CD34+ cells divided into 20 injections. In Group A, the whole protocol was repeated at 6 months. All patients were followed for 1 year.
Results: At baseline, the groups did not differ in age (56±9 years vs. 54±11 years, P=0.42), gender (male: 90% vs. 87%, P=0.69), LVEF (32.2±9.3% vs. 30.0±7.0%, P=0.39), NTproBNP (1525±1030 pg/ml vs. 1753±1008 pg/ml, P=0.47) or 6-minute walk test distance (6MWK: 320±92 m vs. 341±87 m, P=0.72). Within 1 year, there was 1 death in Group A and 2 in Group B. Between baseline and 6 months, we found a significant improvement in LVEF (+6.9±3.3% in Group A, P=0.001; +7.1±3.5% in Group B, P=0.001), decrease in NTproBNP (-578±211 pg/ml in Group A, P=0.02; -633±305 pg/ml in Group B, P=0.01), and increase in 6MWK (+87±21 m in Group A, P=0.03; +92±25 m in Group B, P=0.02). In contrast, we observed no significant changes in any of the groups between 6 months an 1 year (LVEF: +2.1±2.3% in Group A, P=0.19; +0.8±3.1% in Group B, P=0.56; NTproBNP: -215±125 pg/ml in Group A, P=0.26; -33±205 pg/ml in Group B, P=0.77; 6MWK: +27±11 m in Group A, P=0.2; +12±18 m in Group B, P=0.42). This resulted in similar characteristics of both groups at the end of the study (LVEF: 41.0±6.5% in Group A vs. 37.7±5.3% in Group B, P=0.34; NTproBNP: 735±860 pg/ml vs. 1080±978 pg/ml, P=0.20; 6MWK: 430±71 m vs. 435±96 m in Group B, P=0.62).
Conclusions: In patients with DCM, CD34+ cell therapy is associated with improved ventricular function, decrease in NTproBNP, and increased exercise capacity. However, repetitive cell administration does not appear to offer additional benefits in this patient cohort.
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.