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The Five-Year Clinical and Angiographic Follow-Up Outcomes of Intracoronary Transfusion of Circulation-Derived CD34+ Cells for Patients With End-Stage Diffuse Coronary Artery Disease Unsuitable for Coronary Intervention—Phase I Clinical Trial

Sung, Pei-Hsun, MD1,2; Lee, Fan-Yen, MD3; Tong, Meng-Shen, MD1; Chiang, John, Y., PhD4,5; Pei, Sung-Nan, MD6; Ma, Ming-Chun, MD6; Li, Yi-Chen, PhD1; Chen, Yung-Lung, MD1; Wu, Chiung-Jen, MD1; Sheu, Jiunn-Jye, MD3; Lee, Mel, S., MD, PhD7; Yip, Hon-Kan, MD1,2,8,9,10

doi: 10.1097/CCM.0000000000003051
Online Clinical Investigations

Objectives: This study investigated the clinical and angiographic long-term outcomes of intracoronary transfusion of circulation-derived CD34+ cells for patients with end-stage diffuse coronary artery disease unsuitable for coronary intervention.

Design and Setting: A single-center prospective randomized double-blinded phase I clinical trial. Thirty-eight patients undergoing CD34+ cell therapy were allocated into groups 1 (1.0 × 107 cells/each vessel; n = 18) and 2 (3.0 × 107 cells/each vessel; n = 20).

Patients: Those with end-stage diffuse coronary artery disease were unsuitable for percutaneous and surgical coronary revascularization.

Interventions: Intracoronary delivery of circulation-derived CD34+ cells.

Measurements and Main Results: We prospectively evaluated long-term clinical and echocardiographic/angiographic outcomes between survivors and nonsurvivors. By the end of 5-year follow-up, the survival rate and major adverse cardio/cerebrovascular event were 78.9% (30/38) and 36.8% (14/38), respectively. During follow-up period, 31.6% patients (12/38) received coronary stenting for reason of sufficient target vessel size grown-up after the treatment. Endothelial function was significantly reduced in the nonsurvivors than the survivors (p = 0.039). Wimasis image analysis of angiographic findings showed that the angiogenesis was significantly and progressively increased from baseline to 1 and 5 years (all p < 0.001). The 3D echocardiography showed left ventricular ejection fraction increased from baseline to 1 year and then remained stable up to 5 years, whereas left ventricular chamber diameter exhibited an opposite pattern to left ventricular ejection fraction among the survivors. The clinical scores for angina and heart failure were significantly progressively reduced from baseline to 1 and 5 years (all p < 0.001).

Conclusions: CD34+ cell therapy for end-stage diffuse coronary artery disease patients might contribute to persistently long-term effects on improvement of left ventricular function, angina/heart failure, and amelioration of left ventricular remodeling.

1Division of Cardiology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.

2Center for Shockwave Medicine and Tissue Engineering, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan.

3Division of Thoracic and Cardiovascular Surgery, Department of Surgery, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.

4Department of Computer Science and Engineering, National Sun Yat-sen University, Kaohsiung, Taiwan.

5Department of Healthcare Administration and Medical Informatics, Kaohsiung Medical University, Kaohsiung, Taiwan.

6Division of Hema-Oncology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.

7Department of Orthopedics, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University, College of Medicine, Kaohsiung, Taiwan.

8Institute for Translational Research in Biomedicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University, College of Medicine, Kaohsiung, Taiwan.

9Department of Medical Research, China Medical University Hospital, China Medical University, Taichung, Taiwan.

10Department of Nursing, Asia University, Taichung, Taiwan.

This study was performed in Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan.

Drs. Sung and Fan-Yan Lee were equal contributors.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s website (http://journals.lww.com/ccmjournal).

Supported, in part, by a grant from the National Science Council, Taiwan, Republic of China (100-2314-B-182A-077) and by a grant from Chang Gung Memorial Hospital, Chang Gung University (Grant number: CMRPG8B0901 and CMRPG8B0902).

Dr. Pei disclosed work for hire. The remaining authors have disclosed that they do not have any potential conflicts of interest.

For information regarding this article, E-mail: han.gung@msa.hinet.net

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