在创伤性脑损伤后治疗慢性运动缺陷的介质干细胞植入物:随机试验的后期分析
David O Okonkwo1, Peter McAllister1, Achal S Achrol1
1From the Department of Neurological Surgery (D.O.O.), University of Pittsburgh Medical Center, PA; New England Institute for Neurology and Headache (P.M.), Stamford, CT; Department of Neurosurgery (A.S.A.), Loma Linda University Medical Center, CA; Department of Neurosurgery (Y.K.), The University of Tokyo Hospital, Japan; Department of Neurosurgery (M.K.), Hokkaido University Hospital, Sapporo, Japan; Department of Neurology (S.C.C.), University of California, Los Angeles; Westview Clinical Research (A.L.), Placentia, CA; Department of Translational Neurosciences (S.K.), Providence Saint John's Health Center, Santa Monica, CA; The Neurology Center of Southern California (B.M.F.), Carlsbad, CA; Department of Neurology (L.I.G.), University of California, Irvine; UCSF Weill Institute for Neurosciences (A.S.K.), Department of Neurology, University of California, San Francisco; Department of Neurology and Neurological Sciences (N.E.S.), and Stanford Stroke Center, Stanford University School of Medicine and Stanford Health Care, CA; Department of Neurological Surgery (J.W.C.), University of California, Irvine; JCHO Tokyo Shinjuku Medical Center (H.I.), Japan; Department of Neurological Surgery (T.Y.), Okayama University Graduate School of Medicine, Japan; SanBio, Inc. (D.C., B.N., D.B.), Mountain View, CA; Watson & Stonehouse Enterprises LLC (A.H.S.), Pacific Grove, CA; Massachusetts General Hospital and Harvard Medical School (R.M.R.), Boston; Department of Neurosurgery and Stanford Stroke Center (G.K.S.), Stanford University School of Medicine and Stanford Health Care, CA; Biostatistical Consulting Inc. (E.C.P.), Mountain View, CA; and Neurotrauma Rehabilitation Associates LLC (A.H.W.), Littleton, CO.
这项临床试验表明,SB623细胞治疗显著改善了创伤性脑损伤 (TBI) 后慢性缺陷患者的运动功能. 治疗是安全的,并在48周内显示持续的益处.
科学领域:
- 神经科学是一个神经科学.
- 再生医学是一种再生医学.
- 临床试验 临床试验
背景情况:
- 创伤性脑损伤 (TBI) 往往导致持续的运动缺陷.
- 目前对慢性TBI运动缺陷的治疗方法有限.
研究的目的:
- 评价所有基因修饰的介质细胞 (SB623) 细胞的内植入的疗效和安全性,以改善TBI后的慢性运动缺陷.
主要方法:
- 一个双盲,随机化,模拟控制的第二阶段临床试验 (STEMTRA) 涉及61名中度至重度TBI和慢性运动缺陷的参与者.
- 参与者接受了SB623细胞 (三组剂量) 的立体手术植入或虚假手术.
- 主要终点是24周Fugl-Meyer运动量表 (FMMS) 评分的变化.
主要成果:
- 达到了主要终点,显示了SB623组的FMMS得分在24周后与对照组相比显著改善 (p=0.04).
- 运动功能的改善在48周后得到了持续.
- 在SB623和对照组之间,不良事件的发生率相似,没有死亡或因不良事件而退出.
结论:
- 在慢性TBI中,SB623细胞的内植入是一种安全有效的治疗方法,可以改善慢性TBI中的运动缺陷.
- SB623细胞疗法提供了一种潜在的新方法来修改TBI后的慢性神经缺陷.
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