Department of Neurology, University of Texas Medical School at Houston, Houston, TX 77030, USA.
Stroke. 2011 Mar;42(3):825-9. doi: 10.1161/STROKEAHA.110.601914. Epub 2011 Jan 27.
Cell-based therapies represent a new therapeutic approach for stroke. In 2007, investigators from academia, industry leaders, and members of the National Institutes of Health crafted recommendations to facilitate the translational development of cellular therapies as a novel, emerging modality for stroke from animal studies to clinical trials. This meeting was called Stem Cell Therapies as an Emerging Paradigm in Stroke (STEPS) and was modeled on the format of the Stroke Therapy Academic Industry Roundtable (STAIR) meetings. Since publication of the original STEPS guidelines, there has been an explosive growth in the number of cellular products and in the number of new laboratory discoveries that impact the safety and potential efficacy of cell therapies for stroke. Any successful development of a cell product will need to take into consideration several factors, including the preclinical safety and efficacy profile, cell characterization, delivery route, in vivo biodistribution, and mechanism of action. In 2010, a second meeting called STEPS 2 was held to bring together clinical and basic science researchers with industry, regulatory, and National Institutes of Health representatives. At this meeting, participants identified critical gaps in knowledge and research areas that require further studies, updated prior guidelines, and drafted new recommendations to create a framework to guide future investigations in cell-based therapies for stroke.
细胞疗法代表了中风治疗的新方法。2007 年，学术界、工业界领袖和美国国立卫生研究院成员召开会议，制定了相关建议，以促进细胞疗法从动物研究到临床试验的转化发展，使其成为中风治疗的一种新的、新兴模式。这次会议被称为中风中的干细胞治疗：新兴范例（Stem Cell Therapies as an Emerging Paradigm in Stroke，STEPS），其会议模式是基于中风治疗学术工业圆桌会议（Stroke Therapy Academic Industry Roundtable，STAIR）会议的模式。自最初的 STEPS 指南发布以来，细胞产品的数量呈爆炸式增长，许多新的实验室发现也对中风细胞疗法的安全性和潜在疗效产生了影响。任何细胞产品的成功开发都需要考虑多个因素，包括临床前的安全性和疗效概况、细胞特征、给药途径、体内生物分布和作用机制。2010 年，召开了第二次名为 STEPS2 的会议，召集了临床和基础科学研究人员、工业界、监管机构和美国国立卫生研究院代表。在这次会议上，与会者确定了需要进一步研究的知识和研究领域的关键差距，更新了先前的指南，并起草了新的建议，以建立一个框架来指导中风细胞疗法的未来研究。
