Alrasheed Abdulrahim Saleh, Aljahdali Tala Abdullah, Alghafli Israa Aqeel, Alghafli Ghadeer Aqeel, Almuslim Majd Fouad, AlMohish Noor Mohammad, Alabdali Majed Mohammad
Department of Neurosurgery, College of Medicine, King Faisal University, Al Ahsa 31982, Saudi Arabia.
College of Medicine, King Saud bin Abdulaziz University for Health Sciences, Riyadh 11426, Saudi Arabia.
J Clin Med. 2025 Mar 20;14(6):2118. doi: 10.3390/jcm14062118.
Although recent advancements in ischemic stroke management have reduced associated mortality rates, there remains a pressing need for more reliable, efficacious, and well-tolerated therapeutic approaches due to the narrow therapeutic window of current treatment approaches. The current meta-analysis sought to evaluate the safety and efficacy of stem cell-based therapeutic options for patients with ischemic stroke. PubMed, Web of Science, and Cochrane library databases were searched to retrieve randomized controlled trials (RCTs) evaluating the efficacy and safety of stem cell therapy (SCT) in ischemic stroke patients. Key outcomes included the National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS), Barthel Index (BI), Fugl-Meyer Assessment (FMA), infarct size, and safety profile. The random effects model with the continuous method was used to calculate the pooled effect size in Review Manager 5.4.1, and subgroup analyses were performed based on demographics, stroke duration, and SCT delivery protocols. A total of 18 RCTs involving 1026 patients were analyzed, with 538 in the treatment group and 488 in the control group. The mean change in NIHSS score was comparable between groups [MD = -0.80; 95% CI: -2.25, 0.65, < 0.0001]. However, SCT showed better outcomes in mRS [MD = -0.56; 95% CI: -0.76, -0.35, = 0.30] and BI scores [MD = 12.00; 95% CI: 4.00, 20.00, = 0.007]. Additionally, the mean change in FMA score was significantly greater with SCT [MD = 18.16; 95% CI: 6.58, 29.75, = 0.03]. The mean change in infarct volume also favored stem cell therapy [MD = 8.89; 95% CI: -5.34, 23.12, = 0.08]. The safety profile was favorable, with adverse event rates comparable to or lower than controls. SCT offers a safe and effective approach to improving functional outcomes in stroke patients, particularly with early intervention. These findings highlight the potential of SCT in ischemic stroke rehabilitation while underscoring the need for standardized protocols and long-term safety evaluation.
尽管缺血性中风治疗方面的最新进展降低了相关死亡率，但由于当前治疗方法的治疗窗口狭窄，仍迫切需要更可靠、有效且耐受性良好的治疗方法。本荟萃分析旨在评估基于干细胞的治疗方案对缺血性中风患者的安全性和有效性。检索了PubMed、科学网和Cochrane图书馆数据库，以获取评估干细胞疗法（SCT）对缺血性中风患者疗效和安全性的随机对照试验（RCT）。主要结局包括美国国立卫生研究院卒中量表（NIHSS）、改良Rankin量表（mRS）、Barthel指数（BI）、Fugl-Meyer评估（FMA）、梗死灶大小和安全性。在Review Manager 5.4.1中使用连续方法的随机效应模型计算合并效应量，并根据人口统计学、中风持续时间和SCT给药方案进行亚组分析。共分析了18项涉及1026例患者的RCT，治疗组538例，对照组488例。两组间NIHSS评分的平均变化相当[MD = -0.80；95%CI：-2.25，0.65，<0.0001]。然而，SCT在mRS[MD = -0.56；95%CI：-0.76，-0.35，P = 0.30]和BI评分[MD = 12.00；95%CI：4.00，20.00，P = 0.007]方面显示出更好的结果。此外，SCT组FMA评分的平均变化显著更大[MD = 18.16；95%CI：6.58，29.75，P = 0.03]。梗死体积的平均变化也有利于干细胞治疗[MD = 8.89；95%CI：-5.34，23.12，P = 0.08]。安全性良好，不良事件发生率与对照组相当或低于对照组。SCT为改善中风患者的功能结局提供了一种安全有效的方法，尤其是早期干预。这些发现凸显了SCT在缺血性中风康复中的潜力，同时强调了标准化方案和长期安全性评估的必要性。
