Intracoronary Injection of Autologous CD34+ Cells Improves One-Year Left Ventricular Systolic Function in Patients with Diffuse Coronary Artery Disease and Preserved Cardiac Performance—A Randomized, Open-Label, Controlled Phase II Clinical Trial

• Main Authors: Pei-Hsun Sung, Yi-Chen Li, Mel S. Lee, Hao-Yi Hsiao, Ming-Chun Ma, Sung-Nan Pei, Hsin-Ju Chiang, Fan-Yen Lee, Hon-Kan Yip
• Format: Article
• Language: English
• Published: MDPI AG 2020-04-01
• Series: Journal of Clinical Medicine
• Subjects: diffuse coronary artery disease; angiogenesis; CD34+ cells; preserved LVEF; heart failure; angina
• Online Access: https://www.mdpi.com/2077-0383/9/4/1043

This phase II randomized controlled trial tested whether intracoronary autologous CD34+ cell therapy could further improve left ventricular (LV) systolic function in patients with diffuse coronary artery disease (CAD) with relatively preserved LV ejection fraction (defined as LVEF >40%) unsuitable for coronary intervention. Between December 2013 and November 2017, 60 consecutive patients were randomly allocated into group 1 (CD34+ cells, 3.0 × 10⁷/vessel/<i>n</i> = 30) and group 2 (optimal medical therapy; <i>n</i> = 30). All patients were followed for one year, and preclinical and clinical parameters were compared between two groups. Three-dimensional echocardiography demonstrated no significant difference in LVEF between groups 1 and 2 (54.9% vs. 51.0%, respectively, <i>p</i> = 0.295) at 12 months. However, compared with baseline, 12-month LVEF was significantly increased in group 1 (<i>p</i> < 0.001) but not in group 2 (<i>p</i> = 0.297). From baseline, there were gradual increases in LVEF in group 1 compared to those in group 2 at 1-month, 3-months, 6-months and 12 months (+1.6%, +2.2%, +2.9% and +4.6% in the group 1 vs. −1.6%, −1.5%, −1.4% and −0.9% in the group 2; all <i>p</i> < 0.05). Additionally, one-year angiogenesis (2.8 ± 0.9 vs. 1.3 ± 1.1), angina (0.4 ± 0.8 vs. 1.8 ± 0.9) and HF (0.7 ± 0.8 vs. 1.8 ± 0.6) scores were significantly improved in group 1 compared to those in group 2 (all <i>p</i> < 0.001). In conclusion, autologous CD34+ cell therapy gradually and effectively improved LV systolic function in patients with diffuse CAD and preserved LVEF who were non-candidates for coronary intervention (Trial registration: ISRCTN26002902 on the website of ISRCTN registry).