Stem cell therapy: A clinical trial of stroke

Stem cell therapy: A clinical trial of stroke
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DOI:
10.1016/j.clineuro.2012.10.015
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发表时间:
2013-07-01
影响因子:
1.9
通讯作者:
Bose, Sushmita
Bose, Sushmita
中科院分区:
医学4区
文献类型:
--
作者:
Bhasin, Ashu;Srivastava, M. V. Padma;Bose, Sushmita

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背景:印度令人震惊的残疾负担和中风的高患病率鼓励研究人员开发再生疗法来减少临床缺陷。本研究通过临床评分和功能成像(fMRI和DTI)评价自体单个核细胞和间充质细胞移植治疗卒中患者的安全性、可行性和有效性。方法:纳入40例卒中患者,纳入标准为:指标事件3个月~2年,手肌力至少2级;Brunnstrom分期2~5级;意识清醒且可理解。用Fugl Meyer(FM)、改良Barthel指数(MBI)、医学研究理事会(MRC)力量分级、Ashworth音调评分和功能成像对基线、8周和24周进行评估。在2-3小时内静脉输注250毫升生理盐水中的5,000万-6,000万个细胞。结果:干细胞患者的安全性试验曲线正常,没有死亡或细胞相关的不良反应。在结果参数中,干细胞组只有改良的Barthel指数(MBI)显示有统计学意义的改善(p<0.05)。干细胞输注后Brodmann区BA4、BA6区簇状激活增多,提示神经可塑性。结论:自体静脉内干细胞治疗是安全可行的。干细胞作为神经移植的“支架”,可能有助于中风的修复机制。(C)2012爱思唯尔B.V.保留所有权利。
Background: The alarming disability burden and a high prevalence rate of stroke in India has encouraged the researchers to develop regenerative therapies to reduce clinical deficits. This study evaluates safety, feasibility and efficacy of autologous mononuclear and mesenchymal cell transplantation in stroke patients evaluated on clinical scores and functional imaging (fMRI and DTI).Methods: Forty (n = 40) stroke patients were recruited with the inclusion criteria as: 3 months to 2 years of index event, power of hand muscles of at least 2; Brunnstrom stage: 2-5; conscious and comprehendible. Fugl Meyer (FM), modified Barthel Index (mBI), Medical Research Council (MRC) grade for strength, Ashworth tone scale and functional imaging was used for assessments at baseline, 8 weeks and 24 weeks. 50-60 million cells in 250 ml saline were infused intravenously over 2-3 h.Results: The safety test profile was normal with no mortality or cell related adverse reactions in stem cell patients. Among outcome parameters, only modified Barthel Index (mBI) showed statistical significant improvement (p < 0.05) in the stem cell group. An increased number of cluster activation in Brodmann areas BA 4, BA 6 was observed post stem cell infusion indicating neural plasticity.Conclusion: Autologous intravenous stem cell therapy is safe and feasible. Stem cells act as "scaffolds" for neural transplantation and may aid in repair mechanisms in stroke. (C) 2012 Elsevier B.V. All rights reserved.