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Stroke:干细胞疗法可有效治疗中风
浏览:发布时间:2016-06-07 我要打印

    患有中风的患者在经过向大脑中注射干细胞治疗,能够明显地提高其讲话能力、身体强度以及行动力。其中一些患者甚至能够重新行走,这一临床试验的成功意味着我们低估了大脑自愈的能力,也许有一天这种疗法能够使大脑重新恢复功能。

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        "一位71岁的老年女性在治疗开始前仅仅能够活动左手大拇指",该研究的首席研究员,来自斯坦福大学的神经科医生Gary Steinberg说道:"如今她能够行走以及将手举过头顶"

这是第二次通过向脑部注射干细胞使得大脑恢复功能的临床试验。去年英国的一项相似的临床试验也获得了成功。这次试验是由一家叫做"SanBio"的公司发起的。虽然该团队仅仅对18名患者进行了治疗,但这些患者经过治疗后病情全部发生了明显的改善,其中有7名患者改善幅度显著。参与该试验的患者患中风时间从6个月到3年不等。在此之前,他们的病情一直处于停滞状态。在治疗前后,研究者们分别检测了他们的活动能力,评分从1100。他们发现,所有患者在经历了治疗后活动能力平均提高了11.4%。这意味着该疗法能够有效提高患者的生活质量。那么它是怎么工作的呢?该疗法是通过从头部打洞的方式,向大脑负责运动的区域注射干细胞,这一区域在中风患者中受到了损伤。对于具体的治疗机制,研究者们并不太清楚,但随着治疗的不断深入他们能够慢慢找到其中的线索。看上去这一技术似乎是能够将大脑恢复年轻。 

注入的这部分干细胞叫做间充质干细胞,是采集于两名健康人的骨髓中。这些细胞经过改造,能够持续性表达Notch1蛋白,该蛋白主要负责婴儿期大脑的发育。每名患者在这一试验中分别被注入250万、500万以及1000万的细胞。

 在大鼠试验中,作者发现这部分注入的细胞在体内的维持的时间不会超过一个月,但在此期间,这些细胞能够分泌生长因子,促进脑细胞的新连结形成以及组织的再生。

"我们之前认为患者的脑回路已经处于死亡状态,如今,我们需要重新考虑这个问题。我个人认为患者的脑回路仅仅是受到了抑制,我们的治疗手段能够中止这种抑制。这一疗法更像是将成年人的大脑重新变成婴儿的状态,因此能够得到较为理想的修复"

 相关结果发表在最近的《stroke》杂志上。

 

原文:

Clinical Outcomes of Transplanted Modified Bone Marrow-Derived Mesenchymal Stem Cells in Stroke: A Phase 1/2a Study

Gary K. Steinberg, MD, PhD, Douglas Kondziolka, MD, Lawrence R. Wechsler, MD, L. Dade Lunsford, MD, Maria L. Coburn, BA, Julia B. Billigen, RN, BS, Anthony S. Kim, MD, MAS, Jeremiah N. Johnson, MD, Damien Bates, MD, PhD, Bill King, MS, Casey Case, PhD, Michael McGrogan, PhD, Ernest W. Yankee, PhD and Neil E. Schwartz, MD, PhD

Background and Purpose-Preclinical data suggest that cell-based therapies have the potential to improve stroke outcomes.

Methods-Eighteen patients with stable, chronic stroke were enrolled in a 2-year, open-label, single-arm study to evaluate the safety and clinical outcomes of surgical transplantation of modified bone marrow-derived mesenchymal stem cells (SB623).

Results-All patients in the safety population (N=18) experienced at least 1 treatment-emergent adverse event. Six patients experienced 6 serious treatment-emergent adverse events; 2 were probably or definitely related to surgical procedure; none were related to cell treatment. All serious treatment-emergent adverse events resolved without sequelae. There were no dose-limiting toxicities or deaths. Sixteen patients completed 12 months of follow-up at the time of this analysis. Significant improvement from baseline (mean) was reported for: (1) European Stroke Scale: mean increase 6.88 (95% confidence interval, 3.5-10.3; P<0.001),(2) National Institutes of Health Stroke Scale: mean decrease 2.00 (95% confidenceinterval, ?2.7 to ?1.3; P<0.001), (3) Fugl-Meyer total score: mean increase 19.20 (95% confidence interval, 11.4-27.0; P<0.001), and (4) Fugl-Meyer motor function total score: mean increase 11.40 (95% confidence interval, 4.6-18.2; P<0.001). No changes were observed in modified Rankin Scale. The area of magnetic resonance T2 fluid-attenuated inversion recovery signal change in the ipsilateral cortex 1 week after implantation significantly correlated with clinical improvement at 12 months (P<0.001 for European Stroke Scale).

Conclusions-In this interim report, SB623 cells were safe and associated with improvement in clinical outcome end points at 12 months.


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