Chhabra Harvinder Singh, Sarda Kanchan
Spine Service, Indian Spinal Injuries Centre, Vasant Kunj, New Delhi, India.
Indian J Orthop. 2015 Jan-Feb;49(1):56-71. doi: 10.4103/0019-5413.143913.
Stem cell-based interventions aim to use special regenerative cells (stem cells) to facilitate neuronal function beyond the site of the injury. Many studies involving animal models of spinal cord injury (SCI) suggest that certain stem cell-based therapies may restore function after SCI. Currently, in case of spinal cord injuries, new discoveries with clinical implications have been continuously made in basic stem cell research, and stem cell-based approaches are advancing rapidly toward application in patients. There is a huge base of preclinical evidence in vitro and in animal models which suggests the safety and clinical efficacy of cellular therapies after SCI. Despite this, data from clinical studies is not very encouraging and at times confounding. Here, we have attempted to cover preclinical and clinical evidence base dealing with safety, feasibility and efficacy of cell based interventions after SCI. The limitations of preclinical data and the reasons underlying its failure to translate in a clinical setting are also discussed. Based on the evidence base, it is suggested that a multifactorial approach is required to address this situation. Need for standardized, stringently designed multi-centric clinical trials for obtaining validated proof of evidence is also highlighted.
基于干细胞的干预措施旨在利用特殊的再生细胞(干细胞)促进损伤部位以外的神经元功能。许多涉及脊髓损伤(SCI)动物模型的研究表明,某些基于干细胞的疗法可能在脊髓损伤后恢复功能。目前,在脊髓损伤的情况下,基础干细胞研究不断有具有临床意义的新发现,基于干细胞的方法正迅速朝着应用于患者的方向发展。体外和动物模型中有大量临床前证据表明脊髓损伤后细胞疗法的安全性和临床疗效。尽管如此,临床研究数据并不十分令人鼓舞,有时甚至令人困惑。在这里,我们试图涵盖关于脊髓损伤后基于细胞的干预措施的安全性、可行性和疗效的临床前和临床证据基础。还讨论了临床前数据的局限性及其在临床环境中未能转化的原因。基于证据基础,建议需要采取多因素方法来解决这种情况。还强调了需要进行标准化、严格设计的多中心临床试验以获得经过验证的证据证明。