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心血管细胞治疗网络试验的实施:挑战、创新及从心血管细胞治疗研究网络(CCTRN)经验中吸取的教训

Implementation of cardovascular cell therapy network trials: challenges, innovation and lessons learned from experience in the CCTRN.

作者信息

Park Ki E, Moyé Lemuel A, Henry Timothy D, Perin Emerson C, Sayre Shelly L, Bettencourt Judy, Vojvodic Rachel W, Olson Rachel E, Pepine Carl J

机构信息

University of Florida College of Medicine, 1600 SW Archer Rd. Gainesville, FL 32610, USA.

出版信息

Expert Rev Cardiovasc Ther. 2013 Nov;11(11):1495-502. doi: 10.1586/14779072.2013.839943. Epub 2013 Oct 23.

Abstract

The cardiovascular cell therapy network was developed by the National Heart, Lung and Blood Institute to design and conduct clinical trials to advance the field of cardiovascular (CV) cell-based therapy. The Cardiovascular Cell Therapy Network successfully completed three clinical trials involving approximately 300 subjects across five centers and six satellites. Although the concept of a network within clinical trials research is not new, the knowledge gained in the implementation of such large-scale trials, particularly in novel therapeutic areas such as cell therapy is not often detailed in the literature. The purpose of this communication is to summarize key factors in achieving network goals and share the knowledge gained to promote success in future cardiovascular disease cell therapy trials and networks.

摘要

心血管细胞治疗网络由美国国立心肺血液研究所建立,旨在设计并开展临床试验,以推动心血管(CV)细胞治疗领域的发展。心血管细胞治疗网络成功完成了三项临床试验,涉及五个中心和六个卫星机构的约300名受试者。尽管临床试验研究中的网络概念并不新鲜,但在实施此类大规模试验中所获得的知识,尤其是在细胞治疗等新型治疗领域的知识,在文献中并不常被详细阐述。本交流的目的是总结实现网络目标的关键因素,并分享所获得的知识,以促进未来心血管疾病细胞治疗试验和网络的成功。

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