Intracoronary infusion of Wharton's jelly-derived mesenchymal stem cells in acute myocardial infarction: double-blind, randomized controlled trial

The use of adult stem cells is limited by the quality and quantity of host stem cells. It has been demonstrated that Wharton's jelly-derived mesenchymal stem cells (WJMSCs), a primitive stromal population, could integrate into ischemic cardiac tissues and significantly improve heart function. I...

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Published in:	BMC medicine Vol. 13; no. 1; p. 162
Main Authors:	Gao, Lian R, Chen, Yu, Zhang, Ning K, Yang, Xi L, Liu, Hui L, Wang, Zhi G, Yan, Xiao Y, Wang, Yu, Zhu, Zhi M, Li, Tian C, Wang, Li H, Chen, Hai Y, Chen, Yun D, Huang, Chao L, Qu, Peng, Yao, Chen, Wang, Bin, Chen, Guang H, Wang, Zhong M, Xu, Zhao Y, Bai, Jing, Lu, Di, Shen, Yan H, Guo, Feng, Liu, Mu Y, Yang, Yong, Ding, Yan C, Yang, Ye, Tian, Hai T, Ding, Qing A, Li, Li N, Yang, Xin C, Hu, Xiang
Format:	Journal Article
Language:	English
Published:	England BioMed Central Ltd 10-07-2015 BioMed Central
Subjects:	Adult Aged Double-Blind Method Echocardiography Female Humans Male Medical research Medicine, Experimental Mesenchymal Stem Cell Transplantation - methods Middle Aged Myocardial Infarction - therapy Pets Stem cells Tomography Tomography, Emission-Computed, Single-Photon Transplantation Treatment Outcome Ventricular Function, Left Wharton Jelly
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Summary:	The use of adult stem cells is limited by the quality and quantity of host stem cells. It has been demonstrated that Wharton's jelly-derived mesenchymal stem cells (WJMSCs), a primitive stromal population, could integrate into ischemic cardiac tissues and significantly improve heart function. In this randomized, controlled trial, our aim was to assess the safety and efficacy of intracoronary WJMSCs in patients with ST-elevation acute myocardial infarction (AMI). In a multicenter trial, 116 patients with acute ST-elevation MI were randomly assigned to receive an intracoronary infusion of WJMSCs or placebo into the infarct artery at five to seven days after successful reperfusion therapy. The primary endpoint of safety: the incidence of adverse events (AEs) within 18 months, was monitored and quantified. The endpoint of efficacy: the absolute changes in myocardial viability and perfusion of the infarcted region from baseline to four months, global left ventricular ejection fraction (LVEF) from baseline to 18 months were measured using F-18-fluorodeoxyglucose positron emission computed tomography (F-18-FDG-PET) and 99mTc-sestamibi single-photon emission computed tomography (99mTc-SPECT), and two-dimensional echocardiography, respectively. During 18 months follow-up, AEs rates and laboratory tests including tumor, immune, and hematologic indexes were not different between the two groups. The absolute increase in the myocardial viability (PET) and perfusion within the infarcted territory (SPECT) was significantly greater in the WJMSC group [6.9 ± 0.6 % (95 %CI, 5.7 to 8.2)] and [7.1 ± 0.8 % (95 %CI, 5.4 to 8.8) than in the placebo group [3.3 ± 0.7 % (95 %CI, 1.8 to 4.7), P <0.0001] and 3.9 ± 0.6(95 %CI, 2.8 to 5.0), P = 0.002] at four months. The absolute increase in the LVEF at 18 months in the WJMSC group was significantly greater than that in the placebo group [7.8 ± 0.9 (6.0 to approximately 9.7) vs. 2.8 ± 1.2 (0.4 to approximately 5.1), P = 0.001]. Concomitantly, the absolute decreases in LV end-systolic volumes and end-diastolic volumes at 18 months in the WJMSC group were significantly greater than those in the placebo group (P = 0.0004, P = 0.004, respectively). Intracoronary infusion of WJMSCs is safe and effective in patients with AMI, providing clinically relevant therapy within a favorable time window. This study encourages additional clinical trials to determine whether WJMSCs may serve as a novel alternative to BMSCs for cardiac stem cell-based therapy. Clinical Trials NCT01291329 (02/05/2011).
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ISSN:	1741-7015 1741-7015
DOI:	10.1186/s12916-015-0399-z