Osanai Toshiya, Takamiya Soichiro, Morii Yasuhiro, Ogasawara Katsuhiko, Houkin Kiyohiro, Fujimura Miki
Department of Neurosurgery, Faculty of Medicine, Graduate School of Medicine, Hokkaido University, Kita15, Nishi7, Kita-ku, Sapporo, 060-8638, Hokkaido, Japan.
National Institute of Public Health, Wako, Japan.
Sci Rep. 2025 Jul 1;15(1):21214. doi: 10.1038/s41598-025-04405-6.
The efficacy of stem cell therapy for ischemic stroke in terms of functional outcomes remains unclear. We conducted a systematic review and meta-analysis of randomized controlled trials (PROSPERO: CRD42024503763) to assess the efficacy and safety of stem cell therapy for acute/subacute ischemic stroke, focusing on long-term outcomes. Studies of patients undergoing stem cell transplantation within 1 month of stroke onset were included. We searched five databases for publications up to January 17, 2024. Summary data were extracted from published reports. The primary outcome was the modified Rankin Scale (mRS) score. Measures of effect were risk ratios (RRs) with 95% confidence intervals (CIs). A random-effects model was used when I was > 25%; otherwise, a fixed-effects model was used. Common serious adverse events were epilepsy, gastrointestinal disorders, and cardiac disorders. The risk of bias was assessed using the Cochrane Risk of Bias tool version 2. In total, 13 trials involving 872 (519 men) patients were included. The 1-year incidence of mRS scores 0-1 was higher in the cell-therapy group (45/195) than that in the control group (23/179; RR = 1.74 [95% CI = 1.09-2.77]; p = 0.020; I = 0%). The 90-day incidence of mRS scores 0-2 was also higher (RR = 1.31 [95% CI = 1.01-1.70]; p = 0.044; I = 0%). No significant differences were observed in serious adverse events or mortality. Stem cell therapy for acute/subacute ischemic stroke within 1 month of onset is safe and significantly improves long-term functional outcomes, although the mechanisms of action need to be elucidated and treatment protocols standardized to establish stem cell therapy as a standard care option for ischemic stroke.
就功能结局而言，干细胞疗法对缺血性中风的疗效仍不明确。我们对随机对照试验进行了系统评价和荟萃分析（国际前瞻性系统评价注册库：CRD42024503763），以评估干细胞疗法治疗急性/亚急性缺血性中风的疗效和安全性，重点关注长期结局。纳入了中风发作后1个月内接受干细胞移植患者的研究。我们在五个数据库中检索截至2024年1月17日的出版物。从已发表的报告中提取汇总数据。主要结局是改良Rankin量表（mRS）评分。效应量为风险比（RRs）及95%置信区间（CIs）。当I²>25%时，使用随机效应模型；否则，使用固定效应模型。常见的严重不良事件为癫痫、胃肠道疾病和心脏疾病。使用Cochrane偏倚风险工具第2版评估偏倚风险。总共纳入了13项试验，涉及872名（519名男性）患者。细胞治疗组mRS评分0 - 1的1年发生率高于对照组（45/195比23/179；RR = 1.74 [95% CI = 1.09 - 2.77]；p = 0.020；I² = 0%）。mRS评分0 - 2的90天发生率也更高（RR = 1.31 [95% CI = 1.01 - 1.70]；p = 0.044；I² = 0%）。在严重不良事件或死亡率方面未观察到显著差异。中风发作后1个月内对急性/亚急性缺血性中风进行干细胞治疗是安全的，并且能显著改善长期功能结局，尽管作用机制有待阐明，治疗方案也需标准化，以便将干细胞疗法确立为缺血性中风的标准治疗选择。
