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Sham surgery for the trialing of cell-based therapies to the CNS may not be necessary
Cell Stem Cell ( IF 23.9 ) Pub Date : 2024-02-01 , DOI: 10.1016/j.stem.2023.12.004
Viviane Tabar , Roger A. Barker

Sham surgery is often required for cell therapies adopting a randomized placebo-controlled double-blinded trial design. Using the case of dopamine neuron therapy for Parkinson’s disease, we argue that alternative trial designs should be considered instead, for several reasons relating to ethics, patient burden, ease of unblinding, and cost.



中文翻译:

试验中枢神经系统细胞疗法的假手术可能没有必要

采用随机安慰剂对照双盲试验设计的细胞疗法通常需要进行假手术。以多巴胺神经元治疗帕金森病为例,我们认为出于伦理、患者负担、揭盲难易程度和成本等几个原因,应该考虑替代试验设计。

更新日期:2024-02-01
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