A PILOT CLINICAL TRIAL OF CELL THERAPY IN HEART FAILURE WITH PRESERVED EJECTION FRACTION. European journal of heart failure Vrtovec, B., Frljak, S., Poglajen, G., Zemljic, G., Cerar, A., Sever, M., Haddad, F., Wu, J. C. 2022

Abstract

AIMS: We investigated the effects of CD34+ cell therapy in patients with heart failure with preserved ejection fraction (HFpEF).METHODS AND RESULTS: In a prospective pilot study, we enrolled 30 patients with HFpEF. In Phase 1, patients were treated with medical therapy for 6 months. Thereafter, all patients underwent CD34+ cell transplantation. Using electroanatomical mapping, we measured local mechanical diastolic delay and myocardial viability to guide the targeting of cell injections. Patients were followed for 6 months after cell transplantation (Phase 2), and the primary end-point was the difference in change in E/e' between Phase 1 and Phase 2. In Phase 1, the decrease in E/e' was significantly less pronounced than in Phase 2. (-0.33±1.72 vs. -3.77±2.66, P=0.001). During Phase 1, there was no significant change in global systolic strain (GLS; from -12.5±2.4% to -12.8±2.6%, P=0.77), NT-proBNP (from 1463±1247 pg/mL to 1298±931 pg/mL, P=0.31), or 6-minute walk test distance (6MWT; from 391±75 m to 402±93 m, P=0.42). In Phase 2, an improvement was noted in NT-proBNP (from 1298±931 pg/ml to 887±809 pg/ml, P=0.02) and 6MWT (from 402±93 m to 438±72 m, P=0.02). Although GLS did not change significantly in Phase 2 (from -12.8±2.6% to -13.8±2.7%, P=0.36), we found improved local systolic strain at cell injection sites (-3.4±6.8%, P=0.005).CONCLUSIONS: In this non-randomized trial, transendocardial CD34+ cell therapy in HFpEF was associated with an improvement in E/e', NT-proBNP, exercise capacity, and local myocardial strain at the cell injection sites.CLINICAL TRIALS REGISTRATION: Clinicaltrials.gov NCT02923609 This article is protected by copyright. All rights reserved.

View details for DOI 10.1002/ejhf.2596

View details for PubMedID 35775390