静脉注射间充质干细胞治疗缺血性脑卒中的疗效和安全性。
Efficacy and Safety of Intravenous Mesenchymal Stem Cells for Ischemic Stroke.
机构信息
From the Department of Neurology (J.-W.C., O.Y.B., S.J.K.), Samsung Medical Center, Sungkyunkwan University; Translational and Stem Cell Research Laboratory on Stroke (J.-W.C., O.Y.B., G.J.M.) and Stem Cell and Regenerative Medicine Institute (G.J.M.), Samsung Medical Center; Department of Physical and Rehabilitation Medicine (W.H.C., Y.-H.K.), Center for Prevention and Rehabilitation, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul; School of Life Sciences (G.J.M.), BK21 plus KNU Creative BioResearch Group, Kyungpook National University, Daegu; Department of Neurology (S.-K.K.), Gyeongsang National University School of Medicine, Jinju; Department of Neurology (J.S.L.), Ajou University Hospital, School of Medicine, Suwon; and Department of Neurology (S.-I.S.), Keimyung University Dongsan Medical Center, Keimyung University School of Medicine, Daegu, South Korea. Dr. Moon is currently affiliated with the Stem Cell Center, Asan Institute for Life Science and the Department of Convergence Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
出版信息
Neurology. 2021 Feb 16;96(7):e1012-e1023. doi: 10.1212/WNL.0000000000011440. Epub 2021 Jan 20.
OBJECTIVE
To test whether autologous modified mesenchymal stem cells (MSCs) improve recovery in patients with chronic major stroke.
METHODS
In this prospective, open-label, randomized controlled trial with blinded outcome evaluation, patients with severe middle cerebral artery territory infarct within 90 days of symptom onset were assigned, in a 2:1 ratio, to receive preconditioned autologous MSC injections (MSC group) or standard treatment alone (control group). The primary outcome was the score on the modified Rankin Scale (mRS) at 3 months. The secondary outcome was to further demonstrate motor recovery.
RESULTS
A total of 39 and 15 patients were included in the MSC and control groups, respectively, for the final intention-to-treat analysis. Mean age of patients was 68 (range 28-83) years, and mean interval between stroke onset to randomization was 20.2 (range 5-89) days. Baseline characteristics were not different between groups. There was no significant difference between the groups in the mRS score shift at 3 months ( = 0.732). However, secondary analyses showed significant improvements in lower extremity motor function in the MSC group compared to the control group (change in the leg score of the Motricity Index, = 0.023), which was notable among patients with low predicted recovery potential. There were no serious treatment-related adverse events.
CONCLUSIONS
IV application of preconditioned, autologous MSCs with autologous serum was feasible and safe in patients with chronic major stroke. MSC treatment was not associated with improvements in the 3-month mRS score, but we did observe leg motor improvement in detailed functional analyses.
CLASSIFICATION OF EVIDENCE
This study provides Class III evidence that autologous MSCs do not improve 90-day outcomes in patients with chronic stroke.
CLINICALTRIALSGOV IDENTIFIER
NCT01716481.
目的
检验自体修饰间充质干细胞（MSC）是否能改善慢性大卒中老年患者的恢复情况。
方法
这是一项前瞻性、开放标签、随机对照临床试验，采用盲法结局评估，将发病后 90 天内出现严重大脑中动脉区域梗死的患者，按 2:1 的比例随机分为接受预处理自体 MSC 注射（MSC 组）或仅接受标准治疗（对照组）。主要结局为 3 个月时改良 Rankin 量表（mRS）评分。次要结局为进一步证明运动功能恢复。
结果
最终，共有 39 例和 15 例患者分别纳入 MSC 组和对照组进行意向治疗分析。患者平均年龄为 68 岁（范围为 28-83 岁），发病至随机分组的平均时间为 20.2 天（范围为 5-89 天）。两组基线特征无差异。3 个月时 mRS 评分变化两组间无显著差异（ = 0.732）。然而，二次分析显示 MSC 组下肢运动功能较对照组显著改善（运动指数腿部评分变化， = 0.023），且在预测恢复潜能低的患者中更为明显。无严重与治疗相关的不良事件。
结论
慢性大卒中老年患者中应用自体预处理 MSC 联合自体血清是可行且安全的。MSC 治疗与 3 个月时 mRS 评分改善无关，但在详细的功能分析中我们观察到腿部运动的改善。
证据分类
本研究提供 III 级证据，表明自体 MSC 不能改善慢性卒中患者 90 天的结局。
临床试验注册号
NCT01716481。
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