Centre for Nerve Engineering, University College London, London, United Kingdom.
Department of Pharmacology, UCL School of Pharmacy, University College London, London, United Kingdom.
Neurosurgery. 2020 Sep 15;87(4):E456-E472. doi: 10.1093/neuros/nyaa149.
Cell therapies have the potential to revolutionize the treatment of spinal cord injury. Basic research has progressed significantly in recent years, with a plethora of cell types now reaching early-phase human clinical trials, offering new strategies to repair the spinal cord. However, despite initial enthusiasm for preclinical and early-phase clinical trials, there has been a notable hiatus in the translation of cell therapies to routine clinical practice. Here, we review cell therapies that have reached clinical trials for spinal cord injury, providing a snapshot of all registered human trials and a summary of all published studies. Of registered trials, the majority have used autologous cells and approximately a third have been government funded, a third industry sponsored, and a third funded by university or healthcare systems. A total of 37 cell therapy trials have been published, primarily using stem cells, although a smaller number have used Schwann cells or olfactory ensheathing cells. Significant challenges remain for cell therapy trials in this area, including achieving stringent regulatory standards, ensuring appropriately powered efficacy trials, and establishing sustainable long-term funding. However, cell therapies hold great promise for human spinal cord repair and future trials must continue to capitalize on the exciting developments emerging from preclinical studies.
细胞疗法有可能彻底改变脊髓损伤的治疗方法。近年来，基础研究取得了重大进展，大量的细胞类型现已进入早期人体临床试验，为修复脊髓提供了新的策略。然而，尽管对临床前和早期临床试验最初充满热情，但细胞疗法向常规临床实践的转化却出现了明显的中断。在这里，我们回顾了已进入脊髓损伤临床试验的细胞疗法，提供了所有注册人体试验的快照，并总结了所有已发表的研究。在已注册的试验中，大多数使用了自体细胞，大约三分之一是由政府资助的，三分之一是由工业界赞助的，三分之一是由大学或医疗保健系统资助的。共有 37 项细胞治疗试验已经发表，主要使用干细胞，尽管少数使用施万细胞或嗅鞘细胞。该领域的细胞治疗试验仍然面临重大挑战，包括达到严格的监管标准、确保具有足够效力的试验以及建立可持续的长期资金。然而，细胞疗法为人类脊髓修复带来了巨大的希望，未来的试验必须继续利用临床前研究中出现的令人兴奋的进展。
