Challenges enrolling patients with acute ischemic stroke into cell therapy trials.
Challenges enrolling patients with acute ischemic stroke into cell therapy trials.
复制标题
将急性缺血性中风患者纳入细胞治疗试验面临的挑战。
DOI：
10.1089/scd.2012.0404
复制
发表时间：
2013
影响因子：
4
通讯作者：
Savitz,SeanI
中科院分区：
文献类型：
--
作者：
Vahidy,FarhaanS;Alderman,Susan;Savitz,SeanI
自体骨髓来源的单核细胞（MNCs）输注是急性缺血性卒中患者的一种有前途的研究性治疗方法。临床前模型表明，MNCs可以减少神经功能缺损并促进恢复。我们最近完成了一项I期临床试验，以确定这些细胞在急性缺血性中风患者中的安全性和可行性。在这篇文章中，我们讨论了在试验过程中遇到的实际障碍和挑战，并为未来临床试验的设计和规划提供了经验教训，以测试急性缺血性卒中的新型细胞疗法。
Infusion of autologous bone marrow-derived mononuclear cells (MNCs) is a promising investigational therapeutic approach for patients with acute ischemic stroke. Preclinical models indicate that MNCs can reduce neurological deficits and enhance recovery. We recently concluded a phase I clinical trial to determine the safety and feasibility of these cells in patients with acute ischemic stroke. In this article, we discuss practical barriers and challenges encountered during the trial and provide lessons learned for the design and planning of future clinical trials testing novel cell therapies for acute ischemic stroke.