Spinal cord clinical trials and the role for bioengineering

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• 作者：Jared T. Wilcox^a ; ^b ; David Cadotte^a ; ^c ; Michael G. Fehlings^a ; ^b ; ^c ; ^{Michael.Fehlings@uhn.ca} ; ^{michael.fehlings@uhn.on.ca} ; ^{madeleineoh@gmail.com}
• 关键词：ASIA ; American Spinal Injury Association ; AIS ; ASIA Impairment Scale ; ESC ; embryonic stem cell ; FES ; functional electrical stimulation ; FIM ; functional independence measure ; MPSS ; methylprednisolone sodium succinate ; NACTN ; North American Clinical Trials
• 刊名：Neuroscience Letters
• 出版年：2012
• 期刊代码：52_03043940
• 类别：neu
• 出版时间：25 June, 2012
• 卷：519
• 期：2
• 页码：93-102
• 文件大小：535 K

摘要

There is considerable need for bringing effective therapies for spinal cord injury (SCI) to the clinic. Excellent medical and surgical management has mitigated poor prognoses after SCI; however, few advances have been made to return lost function. Bioengineering approaches have shown great promise in preclinical rodent models, yet there remains a large translational gap to carry these forward in human trials. Herein, we provide a framework of human clinical trials, an overview of past trials for SCI, as well as bioengineered approaches that include: directly applied pharmacologics, cellular transplantation, biomaterials and functional neurorehabilitation. Success of novel therapies will require the correct application of comprehensive preclinical studies with well-designed and expertly conducted human clinical trials. While biologics and bioengineered strategies are widely considered to represent the high potential benefits for those who have sustained a spinal injury, few such therapies have been thoroughly tested with appreciable efficacy for use in human SCI. With these considerations, we propose that bioengineered strategies are poised to enter clinical trials.