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Article

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

by
Pei-Hsun Sung
1,2,
Yi-Chen Li
1,
Mel S. Lee
3,
Hao-Yi Hsiao
1,
Ming-Chun Ma
4,
Sung-Nan Pei
5,
Hsin-Ju Chiang
6,7,
Fan-Yen Lee
8,9 and
Hon-Kan Yip
1,2,10,11,12,*
1
Division of Cardiology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University, College of Medicine, Kaohsiung 83301, Taiwan
2
Center for Shockwave Medicine and Tissue Engineering, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung 83301, Taiwan
3
Department of Orthopedics, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University, College of Medicine, Kaohsiung 83301, Taiwan.
4
Division of Hema-Oncology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung 83301, Taiwan
5
Department of Hematology Oncology, E-Da Cancer Hospital and I-Shou University, College of Medicine, Kaohsiung 82445, Taiwan
6
Department of Obstetrics and Gynecology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung 83301, Taiwan
7
Chung Shan Medical University School of Medicine, Taichung 40201, Taiwan
8
Division of Thoracic and Cardiovascular Surgery, Department of Surgery, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung 83301, Taiwan
9
Division of Cardiovascular Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center, Taipei 11490, Taiwan
10
Department of Nursing, Asia University, Taichung 41354, Taiwan
11
Institute for Translational Research in Biomedicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University, College of Medicine, Kaohsiung 83301, Taiwan
12
Department of Medical Research, China Medical University Hospital, China Medical University, Taichung 40402, Taiwan
 
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Author to whom correspondence should be addressed.
J. Clin. Med. 2020, 9(4), 1043; https://doi.org/10.3390/jcm9041043
Submission received: 17 February 2020 / Revised: 28 March 2020 / Accepted: 30 March 2020 / Published: 7 April 2020
(This article belongs to the Special Issue Clinical Research of Percutaneous Coronary Intervention)
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Abstract

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/n = 30) and group 2 (optimal medical therapy; n = 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, p = 0.295) at 12 months. However, compared with baseline, 12-month LVEF was significantly increased in group 1 (p < 0.001) but not in group 2 (p = 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 p < 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 p < 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).
Keywords: diffuse coronary artery disease; angiogenesis; CD34+ cells; preserved LVEF; heart failure; angina; dyspnea diffuse coronary artery disease; angiogenesis; CD34+ cells; preserved LVEF; heart failure; angina; dyspnea

Share and Cite

MDPI and ACS Style

Sung, P.-H.; Li, Y.-C.; Lee, M.S.; Hsiao, H.-Y.; Ma, M.-C.; Pei, S.-N.; Chiang, H.-J.; Lee, F.-Y.; Yip, H.-K. 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. J. Clin. Med. 2020, 9, 1043. https://doi.org/10.3390/jcm9041043

AMA Style

Sung P-H, Li Y-C, Lee MS, Hsiao H-Y, Ma M-C, Pei S-N, Chiang H-J, Lee F-Y, Yip H-K. 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. Journal of Clinical Medicine. 2020; 9(4):1043. https://doi.org/10.3390/jcm9041043

Chicago/Turabian Style

Sung, Pei-Hsun, Yi-Chen Li, Mel S. Lee, Hao-Yi Hsiao, Ming-Chun Ma, Sung-Nan Pei, Hsin-Ju Chiang, Fan-Yen Lee, and Hon-Kan Yip. 2020. "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" Journal of Clinical Medicine 9, no. 4: 1043. https://doi.org/10.3390/jcm9041043

APA Style

Sung, P.-H., Li, Y.-C., Lee, M. S., Hsiao, H.-Y., Ma, M.-C., Pei, S.-N., Chiang, H.-J., Lee, F.-Y., & Yip, H.-K. (2020). 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. Journal of Clinical Medicine, 9(4), 1043. https://doi.org/10.3390/jcm9041043

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