Real-World Insights Group, Centre for Liver Research and Diagnostics, Deccan College of Medical sciences, 500058 Hyderabad, India.
Department of Genetics, Osmania University, 500058 Hyderabad, India.
Therapie. 2021 May-Jun;76(3):201-210. doi: 10.1016/j.therap.2020.06.011. Epub 2020 Jun 27.
To summarize the evidence on the efficacy and safety of neural stem cell therapy (NSCT) for the treatment of spinal cord injury (SCI).
A systematic literature review of Medline®, EMBASE® and Cochrane library was performed to identify studies reporting efficacy and safety of NSCT in SCI. Articles were included if they reported efficacy and safety data of SCI patients who received NSCT.
Overall, four studies of the 277 records met all the study eligibility criteria. Over the 1-year follow-up period, motor scores were significantly higher among patients who received NSCT compared with those who did not (American Spinal Injury Association [ASIA] motor scores (mean±standard deviation [SD]): 7.9±1.2 versus 3.9±0.6; upper extremity motor score: 7.8±2.1 versus 3.9±0.6, both P<0.05). Sensory scores (pinprick score: 4.8±1.3 versus 2.9±0.6; P=0.5; light touch score: 6.9±3.1 versus 2.3±0.5, P=0.3), ASIA impairment scale (26% versus 7%) or pain score (baseline: 2.4±0.6; 1-year: 3.4±0.4) were comparable in both NSCT and non-NSCT cohorts. Over the 1-year follow-up period, the graded redefined assessment of strength, sensibility, and prehension and international standards for neurological classification of SCI scores showed a mean improvement of 14.8 and 17.8 points respectively. Overall, treatment with NSCT showed favorable safety and tolerability profile.
Due to the limited and poor-quality evidence, it is too early to make robust conclusions on the efficacy of NSCT in the treatment of SCI. However, based on the included studies, NSCT seems to be a potential option worth exploring among patients with SCI. Nonetheless, prospective, randomized trials in larger cohorts are needed to validate the efficacy and safety of NSCT in the treatment of SCI.
总结神经干细胞治疗(NSCT)治疗脊髓损伤(SCI)的疗效和安全性证据。
对 Medline®、EMBASE® 和 Cochrane 图书馆进行系统文献回顾,以确定报告 NSCT 治疗 SCI 疗效和安全性的研究。如果报告了接受 NSCT 的 SCI 患者的疗效和安全性数据,则将文章纳入研究。
在 277 份记录中,共有 4 项研究符合所有研究纳入标准。在 1 年的随访期间,接受 NSCT 的患者的运动评分明显高于未接受 NSCT 的患者(美国脊髓损伤协会[ASIA]运动评分(均值±标准差[SD]):7.9±1.2 与 3.9±0.6;上肢运动评分:7.8±2.1 与 3.9±0.6,均 P<0.05)。感觉评分(刺痛评分:4.8±1.3 与 2.9±0.6;P=0.5;轻触评分:6.9±3.1 与 2.3±0.5,P=0.3)、ASIA 损伤量表(26% 与 7%)或疼痛评分(基线:2.4±0.6;1 年:3.4±0.4)在 NSCT 和非 NSCT 组中均无差异。在 1 年的随访期间,重新定义的力量、感觉和抓握分级评估以及国际 SCI 神经分类标准评分均显示平均改善 14.8 和 17.8 分。总的来说,NSCT 的治疗显示出良好的安全性和耐受性。
由于证据有限且质量较差,目前还为时过早,无法对 NSCT 治疗 SCI 的疗效得出可靠结论。然而,基于纳入的研究,NSCT 似乎是 SCI 患者值得探索的潜在选择。然而,需要更大规模队列的前瞻性、随机试验来验证 NSCT 治疗 SCI 的疗效和安全性。