短暂性发热:与来自真实世界的间充质基质细胞和固体线索相关的唯一治疗相关不良事件。

Yang Wang, Qiuying Mou, Hanxiao Yi, Zilu Meng
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引用次数: 0

摘要

背景:研究间充质基质细胞(MSC)的试验数量在3年内激增,这促使人们对新出现的MSC治疗相关不良事件进行分析。目的:评估MSC治疗的安全性,为MSC的临床翻译提供可靠证据。方法:对截至2023年4月20日发表的随机临床试验(RCT)进行荟萃分析。比值比(OR)和95%机密区间(CI)用于显示合并结果。结果:152项随机临床试验(RCT)纳入了9228名接受自体或同种异体脂肪组织、骨髓、沃顿果冻和胎盘组织间充质干细胞治疗的个体的分析。我们发现了适当的21例MSC治疗相关不良事件(TRAE),其中发烧[OR,1.61,95%CI:1.22-2.11,P结论:迄今为止,我们的结果表明,发烧是唯一与MSC密切相关的不良事件。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Transient Fever: The Sole Treatment-Related Adverse Event Associated with Mesenchymal Stromal Cells and Solid Clues from the Real World.

Background: The number of trials investigating mesenchymal stromal cells (MSCs) soars within 3 years which urges a study analysing emerging MSC treatment-related adverse events.

Aim: To assess the safety of MSC therapy and provide solid evidence for clinical translation of MSC.

Methods: A meta-analysis of randomized clinical trials (RCTs) published up to April 20th, 2023 was performed. Odds ratio (OR) and 95% confidential intervals (CIs) were used to display pooled results.

Results: 152 randomized clinical trials (RCTs) that incorporated 9228 individuals treated with MSCs from autologous or allogenic adipose tissue, bone marrow, Wharton's Jelly, and placenta tissue were included in the analysis. We discovered appropriate 21 MSC treatment-related adverse events (TRAEs), of which fever [OR, 1.61, 95% CI: 1.22-2.11, p<0.01] was the sole event that was closely associated with MSC therapy. MSCs also trended to lower the incidence rate of tachycardia [OR, 0.83, 95% CI: 0.64-1.09, p=0.14] and fatigue [OR, 0.18, 95% CI: 0.61-1.07, p=0.18]. A separate analysis of studies with long-term follow-up (more than 1 year) demonstrated the close relationship between MSCs and fever [OR, 1.75, 95% CI: 1.26-2.24, p<0.01]. The rest TRAEs did not associate themselves with MSC therapy. Dose-response was also conducted for fever, linearity was discovered between MSCs from allogeneic tissue and Wharton's Jelly and fever.

Conclusion: To date, our results suggest that fever is the only AE closely associated with MSCs.

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