Rascón-Ramírez Fernando José, Esteban-García Noelia, Barcia Juan Antonio, Trondin Albert, Nombela Cristina, Sánchez-Sánchez-Rojas Leyre
Department of Neurosurgery, Hospital Cl nico San Carlos, Madrid, Spain.
Regenerative Medicine and Advanced Therapies Laboratory, Instituto de Investigación Sanitaria San Carlos (IdISSC), Hospital Cl nico San Carlos, Madrid, Spain.
Front Cell Dev Biol. 2021 Jun 23;9:621645. doi: 10.3389/fcell.2021.621645. eCollection 2021.
Clinical trials of cell therapies that target stroke started at the beginning of this century and they have experienced a significant boost in recent years as a result of promising data from basic research studies. The increase in the information available has paved the way to carry out more innovative and varied human studies. Efforts have focused on the search for a safe and effective treatment to stimulate neuro-regeneration in the brain and to reduce the sequelae of stroke in patients. Therefore, this review aims to evaluate the clinical trials using cell therapy to treat stroke published to date and assess their limitations. From 2000 to date, most of the published clinical trials have focused on phases I or II, and the vast majority of them demonstrate that stem cells are essentially safe to use when administered by different routes, with transient and mild adverse events that do not generally have severe consequences for health. In general, there is considerable variation in the trials in terms of statistical design, sample size, the cells used, the routes of administration, and the functional assessments (both at baseline and follow-up), making it difficult to compare the studies. From this general description, possibly the experimental protocol is the main element to improve in future studies. Establishing an adequate experimental and statistical design will be essential to obtain favorable and reliable results when conducting phase III clinical trials. Thus, it is necessary to standardize the criteria used in these clinical trials in order to aid comparison. Shortly, cell therapy will be a key approach in the treatment of stroke if adequate and comprehensive levels of recovery are to be achieved.
针对中风的细胞疗法临床试验始于本世纪初，近年来，由于基础研究的 promising 数据，该疗法得到了显著推动。可用信息的增加为开展更具创新性和多样性的人体研究铺平了道路。研究重点在于寻找一种安全有效的治疗方法，以刺激大脑神经再生并减少中风患者的后遗症。因此，本综述旨在评估迄今为止已发表的使用细胞疗法治疗中风的临床试验，并评估其局限性。从2000年至今，大多数已发表的临床试验集中在I期或II期，其中绝大多数表明，干细胞通过不同途径给药时基本安全，不良事件短暂且轻微，一般不会对健康造成严重后果。总体而言，这些试验在统计设计、样本量、所用细胞、给药途径以及功能评估（基线和随访时）方面存在相当大的差异，这使得研究之间难以比较。从这个总体描述来看，可能实验方案是未来研究中需要改进的主要因素。建立适当的实验和统计设计对于在进行III期临床试验时获得有利且可靠的结果至关重要。因此，有必要规范这些临床试验中使用的标准，以帮助进行比较。简而言之，如果要实现足够全面的恢复水平，细胞疗法将成为治疗中风的关键方法。
