Efficacy and safety of hematopoietic and mesenchymal stem cells in multiple sclerosis: a meta-analysis.

IF 1.5 4区医学 Q3 CLINICAL NEUROLOGY

Neurological Research Pub Date : 2025-06-25 DOI:10.1080/01616412.2025.2521712

Shampa Maji, Archana Mishra, Anand Srinivasan, Rituparna Maiti

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引用次数: 0

Abstract

Objective: Currently available treatment options for multiple sclerosis (MS) have limited efficacy and/or safety concerns. Various mesenchymal stem cells and hematopoietic stem cells have been evaluated in recent clinical trials. The present meta-analysis was conducted to assess the safety and efficacy of stem cell therapy in multiple sclerosis.

Methods: PubMed/MEDLINE, EMBASE, Cochrane Database, Scopus, and clinical trial registries were searched, and 11 RCTs were included. Quality assessment was performed using the risk-of-bias assessment 2 tool, and the random-effects model was used to estimate the effect size. Subgroup analysis, sensitivity analysis, and meta-regression were performed as applicable. PRISMA reporting guidelines were followed for reporting.

Results: A total data of 691 patients from 11 RCTs were included, and it showed that there was a greater change in EDSS score from baseline in the stem cell therapy arm as compared to the control arm (MD:-0.35; 95%CI: -0.79 to 0.08; p = 0.104), but was not significant statistically. The change in number of T2 lesions was also not statistically significant between the groups (MD:-0.75; 95%CI: -4.16 to 2.66; p = 0.619). Number of patients with at least one TEAE were comparable between the groups (OR:0.99; 95%CI: 0.61 to 1.62; p = 0.977).

Conclusion: Stem cell therapy is safe; however, it is no better than control (mostly placebo, mitoxantrone and conventional disease-modifying therapy) in the treatment of MS. Well-designed, adequately powered randomized controlled trials focusing on standardized stem cell types, routes, and dosing are essential to clarify their therapeutic role in multiple sclerosis.

Prospero registration number: CRD42023457808.

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造血和间充质干细胞治疗多发性硬化症的疗效和安全性：一项荟萃分析。

目的：目前可用的多发性硬化症（MS）治疗方案存在有限的疗效和/或安全性问题。各种间充质干细胞和造血干细胞在最近的临床试验中得到了评价。本荟萃分析旨在评估干细胞治疗多发性硬化症的安全性和有效性。方法：检索PubMed/MEDLINE、EMBASE、Cochrane数据库、Scopus和临床试验注册库，纳入11项rct。采用偏倚风险评估2工具进行质量评估，采用随机效应模型估计效应大小。适用时进行亚组分析、敏感性分析和元回归分析。报告遵循了PRISMA报告准则。结果：共纳入11项rct的691例患者的数据，结果显示干细胞治疗组的EDSS评分与基线相比有更大的变化(MD:-0.35；95%CI: -0.79 ~ 0.08；P = 0.104)，但差异无统计学意义。两组间T2病变数量的变化也无统计学意义(MD:-0.75；95%CI: -4.16 ~ 2.66；p = 0.619)。两组之间至少发生一次TEAE的患者数量具有可比性(OR:0.99；95%CI: 0.61 ~ 1.62；p = 0.977)。结论：干细胞治疗是安全的；然而，在多发性硬化症的治疗中，它并不比对照组（主要是安慰剂、米托蒽醌和传统的疾病改善疗法）更好。精心设计、充分支持的随机对照试验，重点关注标准化的干细胞类型、途径和剂量，对于阐明它们在多发性硬化症中的治疗作用至关重要。普洛斯彼罗注册号：CRD42023457808。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Neurological Research 医学-临床神经学

CiteScore

3.60

自引率

0.00%

发文量

116

审稿时长

5.3 months

期刊介绍： Neurological Research is an international, peer-reviewed journal for reporting both basic and clinical research in the fields of neurosurgery, neurology, neuroengineering and neurosciences. It provides a medium for those who recognize the wider implications of their work and who wish to be informed of the relevant experience of others in related and more distant fields. The scope of the journal includes: •Stem cell applications •Molecular neuroscience •Neuropharmacology •Neuroradiology •Neurochemistry •Biomathematical models •Endovascular neurosurgery •Innovation in neurosurgery.