中枢神经系统疾病随机对照试验中的阳性和阴性细胞治疗。

International review of neurobiology Pub Date : 2023-01-01 Epub Date: 2023-09-15 DOI:10.1016/bs.irn.2023.05.017
Di Chen, Hongyun Huang, Hooshang Saberi, Hari Shanker Sharma
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引用次数: 0

摘要

20多年来,神经修复细胞疗法已被用于治疗神经系统疾病患者。现在还很难回答哪种细胞真正能在改善这些患者的生活质量方面发挥作用。非随机临床试验或研究无法为回答这一关键问题提供有力证据。在这篇综述中,我们总结了细胞疗法治疗中枢神经疾病的随机临床试验,如中风、脊髓损伤、脑瘫(CP)、帕金森病(PD)、多发性硬化症(MS)、脑外伤、肌萎缩侧索硬化症(ALS)等。大多数类型的细胞疗法对中风、脑外伤和肌萎缩侧索硬化症都有负面影响。在这一级别的循证医学中,有几种细胞疗法显示出神经修复作用,例如嗅觉吞噬细胞治疗慢性缺血性中风。某些类型的细胞在相同或不同的疾病中表现出来自不同团队的阳性或阴性影响。我们分析了阴性结果可能失败的原因以及阳性结果的细胞生物学适当性基础。基于随机对照试验的治疗结果和合理的分析,我们建议:(1)进一步进行成功的细胞治疗试验,并取得积极的结果,以提高神经修复效果;(2) 避免在相同的疾病中重复失败的细胞治疗,因为用类似的治疗方法(如细胞剂量、移植方式、窗口时间等)进行治疗是无稽之谈。此外,我们强烈建议不要对随机临床试验中显示阴性结果的细胞进行非随机临床试验。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Positive and negative cell therapy in randomized control trials for central nervous system diseases.

Neurorestorative cell therapies have been tested to treat patients with nervous system diseases for over 20 years. Now it is still hard to answer which kinds of cells can really play a role on improving these patients' quality of life. Non-randomized clinical trials or studies could not provide strong evidences in answering this critical question. In this review, we summarized randomized clinical trials of cell therapies for central nervous diseases, such as stroke, spinal cord injury, cerebral palsy (CP), Parkinson's disease (PD), multiple sclerosis (MS), brain trauma, amyotrophic lateral sclerosis (ALS), etc. Most kinds of cell therapies demonstrated negative results for stoke, brain trauma and amyotrophic lateral sclerosis. A few kinds of cell therapies showed neurorestorative effects in this level of evidence-based medicine, such as olfactory ensheating cells for chronic ischemic stroke. Some kinds of cells showed positive or negative effects from different teams in the same or different diseases. We analyzed the possible failed reasons of negative results and the cellular bio-propriety basis of positive results. Based on therapeutic results of randomized control trials and reasonable analysis, we recommend: (1) to further conduct trials for successful cell therapies with positive results to increase neurorestorative effects; (2) to avoid in repeating failed cell therapies with negative results in same diseases because it is nonsense for them to be done with similar treatment methods, such as cell dosage, transplanting way, time of window, etc. Furthermore, we strongly suggest not to do non-randomized clinical trials for cells that had shown negative results in randomized clinical trials.

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