Cellular treatments for spinal cord injury: the time is right for clinical trials.
Cellular treatments for spinal cord injury: the time is right for clinical trials.
复制标题
DOI：
10.1007/s13311-011-0076-7
复制
发表时间：
2011-10
影响因子：
5.7
通讯作者：
Vawda, Reaz
中科院分区：
文献类型：
--
作者：
Fehlings, Michael G.;Vawda, Reaz
关键词：
在美国，超过100万人患有脊髓损伤（SCI）。尽管医学进步，许多SCI患者仍然经历严重的神经功能障碍，运动，感觉和自主神经功能丧失。细胞疗法非常适合解决SCI后继发事件的多因素性质。我们对SCI的病理生理学、结构和功能磁共振成像、图像引导显微神经外科技术和可移植细胞生物学的理解取得了显着进展，使得基于细胞的再生技术能够在临床中使用。值得注意的是，有十几个最近完成的、正在进行的或正在招募的SCI细胞疗法临床试验反映了许多关键利益相关者的观点。再生神经科学领域已经达到了临床试验在科学和伦理上是合理的阶段。虽然实验模型和分析方法和技术不断发展，但没有一个模型能完全复制人类的状况。人们认识到，在临床试验的同时，还需要对挫伤性/压缩性SCI的颈部模型进行更多的研究。同样重要的是，通过在动物模型中建立和验证的实验方法所取得的进展的临床转化向前迈进，以满足SCI患者的迫切需求，并推进再生神经科学领域。然而，必须以最严格和最明智的方式进行此类翻译工作，以确定安全性和可能的有效性，并为临床医生和基础科学家提供关键信息，这将有助于改进再生技术以及验证和完善现有的临床前动物模型和研究方法。再生神经科学领域不应该停滞在动物模型阶段，相反，临床试验需要集中，安全和道德，并得到强大的，与临床相关的临床前研究策略的支持。本文的在线版本（doi：10.1007/s13311-011-0076-7）包含补充材料，可供授权用户使用。
More than 1 million people in the United States live with a spinal cord injury (SCI). Despite medical advances, many patients with SCIs still experience substantial neurological disability, with loss of motor, sensory, and autonomic function. Cell therapy is ideally suited to address the multifactorial nature of the secondary events following SCI. Remarkable advances in our understanding of the pathophysiology of SCI, structural and functional magnetic resonance imaging, image-guided micro-neurosurgical techniques, and transplantable cell biology have enabled the use of cell-based regenerative techniques in the clinic. It is important to note that there are more than a dozen recently completed, ongoing, or recruiting cell therapy clinical trials for SCI that reflect the views of many key stakeholders. The field of regenerative neuroscience has reached a stage in which the clinical trials are scientifically and ethically justified. Although experimental models and analysis methods and techniques continue to evolve, no model will completely replicate the human condition. It is recognized that more work with cervical models of contusive/compressive SCI are required in parallel with clinical trials. It is also important that the clinical translation of advances made through well-established and validated experimental approaches in animal models move forward to meet the compelling needs of individuals with SCI and to advance the field of regenerative neuroscience. However, it is imperative that such efforts at translation be done in the most rigorous and informed fashion to determine safety and possible efficacy, and to provide key information to clinicians and basic scientists, which will allow improvements in regenerative techniques and the validation and refinement of existing preclinical animal models and research approaches. The field of regenerative neuroscience should not be stalled at the animal model stage, but instead the clinical trials need to be focused, safe, and ethical, backed up by a robust, translationally relevant preclinical research strategy. The online version of this article (doi:10.1007/s13311-011-0076-7) contains supplementary material, which is available to authorized users.
登录
查看更多内容
影响因子：
3.3
作者：
Brierley, CMH;Crang, AJ;Blakemore, WF
通讯作者：
Blakemore, WF
影响因子：
16.2
作者：
Aboody, Karen;Capela, Alexandra;Temple, Sally
通讯作者：
Temple, Sally
影响因子：
6.2
作者：
Bai, Lianhua;Lennon, Donald P.;Eaton, Valerie;Maier, Kari;Caplan, Arnold I.;Miller, Stephen D.;Miller, Robert H.
通讯作者：
Miller, Robert H.
影响因子：
4.2
作者：
Bruce, JH;Norenberg, MD;Dietrich, D
通讯作者：
Dietrich, D
影响因子：
2.5
作者：
CLEMENTE, CD;WINDLE, WF
通讯作者：
WINDLE, WF