Cell therapy for ischemic stroke: Are differences in preclinical and clinical study design responsible for the translational loss of efficacy?
Cell therapy for ischemic stroke: Are differences in preclinical and clinical study design responsible for the translational loss of efficacy?
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DOI：
10.1002/ana.25493
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发表时间：
2019-07-01
影响因子：
11.2
通讯作者：
Jolkkonen, Jukka
中科院分区：
文献类型：
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作者：
Cui, Li-li;Golubczyk, Dominika;Jolkkonen, Jukka
细胞疗法是促进中风后恢复的一种有吸引力的策略。不同的细胞类型和几种治疗策略已成功应用于动物模型，但在中风患者中的疗效尚未得到证实。我们假设临床前试验和临床试验之间的显著设计差异可能是造成这种情况的原因。使用Meta分析方法并比较临床前与临床试验，我们揭示并讨论了这种设计差异的初步证据。虽然现有数据集的数量还不足以得出明确的结论，但这些发现可能代表了通过协调临床前和临床研究设计实现疗效的路标。
Cell therapy is an attractive strategy for enhancing post‐stroke recovery. Different cell types and several treatment strategies have been successfully applied in animal models, but efficacy in stroke patients has not yet been confirmed. We hypothesize that the significant design differences between preclinical and clinical trials may account for this situation. Using a meta‐analysis approach and comparing preclinical with clinical trials, we reveal and discuss preliminary evidence for such design differences. While available datasets are not yet numerous enough to draw definitive conclusions, these findings may represent signposts on the route to efficacy by harmonizing preclinical and clinical study designs.