Government Hospital, Velayuthampalayam, Karur, Tamil Nadu, India; Orthopaedic Research Group, Coimbatore, Tamil Nadu, India; Indian Stem Cells Study Group, Lucknow, India.
Orthopaedic Research Group, Coimbatore, Tamil Nadu, India; Indian Stem Cells Study Group, Lucknow, India; Department of Orthopaedics, School of Medical Sciences and Research, Sharda University, Greater Noida, India.
Cytotherapy. 2021 Mar;23(3):186-197. doi: 10.1016/j.jcyt.2020.09.007. Epub 2020 Nov 9.
The authors aim to analyze the evidence in the literature regarding the efficacy and safety of mesenchymal stem cell (MSC) therapy in human subjects with traumatic spinal cord injury (SCI) and identify its potential role in the management of SCI.
The authors conducted independent and duplicate searches of electronic databases, including PubMed, Embase and the Cochrane Library, until May 2020 for studies analyzing the efficacy and safety of stem cell therapy for SCI. American Spine Injury Association (ASIA) impairment scale (AIS) grade improvement, ASIA sensorimotor score, activities of daily living score, residual urine volume, bladder function improvement, somatosensory evoked potential (SSEP) improvement and adverse reactions were the outcomes analyzed. Analysis was performed in R platform using OpenMeta[Analyst] software.
Nineteen studies involving 670 patients were included for analysis. On analysis, the intervention group showed statistically significant improvement in AIS grade (P < 0.001), ASIA sensory score (P < 0.017), light touch (P < 0.001), pinprick (P = 0.046), bladder function (P = 0.012), residual urine volume (P = 0.023) and SSEP (P = 0.002). However, no significant difference was noted in motor score (P = 0.193) or activities of daily living score (P = 0.161). Although the intervention group had a significant increase in complications (P < 0.001), no serious or permanent adverse events were reported. On subgroup analysis, low concentration of MSCs (<5 × 10 cells) and initial AIS grade A presentation showed significantly better outcomes than their counterparts.
The authors' analysis establishes the efficacy and safety of MSC transplantation in terms of improvement in AIS grade, ASIA sensory score, bladder function and electrophysiological parameters like SSEP compared with controls, without major adverse events. However, further research is needed to standardize dose, timing, route and source of MSCs used for transplantation.
作者旨在分析有关间充质干细胞（MSC）治疗外伤性脊髓损伤（SCI）患者的疗效和安全性的文献证据，并确定其在 SCI 治疗中的潜在作用。
作者对电子数据库（包括 PubMed、Embase 和 Cochrane 图书馆）进行了独立且重复的搜索，直到 2020 年 5 月，以分析干细胞治疗 SCI 的疗效和安全性的研究。美国脊柱损伤协会（ASIA）损伤量表（AIS）等级改善、ASIA 感觉运动评分、日常生活活动评分、残余尿量、膀胱功能改善、体感诱发电位（SSEP）改善和不良反应是分析的结果。使用 R 平台中的 OpenMeta[Analyst]软件进行分析。
纳入了 19 项涉及 670 例患者的研究进行分析。分析结果显示，干预组在 AIS 等级（P<0.001）、ASIA 感觉评分（P<0.017）、轻触（P<0.001）、刺痛（P=0.046）、膀胱功能（P=0.012）、残余尿量（P=0.023）和 SSEP（P=0.002）方面均有统计学意义上的显著改善。但是，运动评分（P=0.193）或日常生活活动评分（P=0.161）方面无显著差异。虽然干预组并发症发生率显著增加（P<0.001），但未报告严重或永久性不良事件。亚组分析显示，低浓度 MSC（<5×10 个细胞）和初始 AIS 等级 A 表现的患者的疗效显著优于对照组。
作者的分析确立了 MSC 移植在改善 AIS 等级、ASIA 感觉评分、膀胱功能和 SSEP 等电生理参数方面的疗效和安全性，与对照组相比无重大不良事件。然而，需要进一步研究以规范用于移植的 MSC 的剂量、时间、途径和来源。
