基于细胞的疗法治疗人类脊髓损伤的试验的范围综述。
A scoping review of trials for cell-based therapies in human spinal cord injury.
机构信息
Northern Foundation School, Newcastle Upon Tyne University Hospitals, Newcastle, UK.
University of Cambridge School of Clinical Medicine, Cambridge, UK.
出版信息
Spinal Cord. 2020 Aug;58(8):844-856. doi: 10.1038/s41393-020-0455-1. Epub 2020 Apr 6.
INTRODUCTION
Spinal cord injury (SCI) is associated with significant and life-long disability. Yet, despite decades of research, no regenerative treatment has reached clinical practice. Cell-based therapies are one possible regenerative strategy beginning to transfer to human trials from a more extensive pre-clinical basis.
METHODS
We therefore conducted a scoping review to synthesise all cell-based trials in SCI to consider the current state of the field and the cell transplant type or strategy with greatest promise. A search strategy of MEDLINE returned 1513 results. All clinical trials including adult human patients with acute or chronic, compete or incomplete SCI and a recorded ASIA score were sought. Exclusion criteria included non-traumatic SCI, paediatric patients and animal studies. A total of 43 studies, treating 1061 patients, were identified. Most trials evaluated cells from the bone marrow (22 papers, 660 patients) or the olfactory bulb (10 papers, 245 patients).
RESULTS
Cell transplantation does appear to be safe, with no serious adverse effects being reported in the short-term. 86% of trials described efficacy as a primary outcome. However, varying degrees of outcome reporting prevented meta-analysis. No emerging cell type or technique was identified. The majority of trials, 53%, took place in developing countries, which may suggest more stringent regulatory requirements within Western countries.
CONCLUSION
We believe cell-based transplantation translation remains in its infancy and that, although further robust clinical research is required, it is an important strategy to consider in the treatment of SCI.
简介
脊髓损伤(SCI)与显著且终身的残疾有关。然而,尽管经过了几十年的研究,仍然没有一种再生疗法能够应用于临床实践。基于细胞的疗法是一种可能的再生策略,已经从更广泛的临床前基础开始向人体试验转移。
方法
因此,我们进行了范围综述,以综合所有基于细胞的 SCI 试验,考虑该领域的当前状况以及最有前途的细胞移植类型或策略。对 MEDLINE 的搜索策略返回了 1513 个结果。所有临床试验均包括急性或慢性、完全或不完全 SCI 的成年人类患者,以及记录的 ASIA 评分。排除标准包括非创伤性 SCI、儿科患者和动物研究。共确定了 43 项研究,涉及 1061 名患者。大多数试验评估了来自骨髓(22 篇论文,660 名患者)或嗅球(10 篇论文,245 名患者)的细胞。
结果
细胞移植似乎是安全的,在短期内没有报告严重的不良事件。86%的试验将疗效描述为主要结果。然而,由于不同程度的结果报告,无法进行荟萃分析。没有发现新的细胞类型或技术。大多数试验(53%)发生在发展中国家,这可能表明西方国家的监管要求更为严格。
结论
我们认为基于细胞的移植转化仍处于起步阶段,尽管需要进一步进行强有力的临床研究,但它是治疗 SCI 的一种重要策略。