临床应用间充质干细胞治疗脊髓损伤的试验研究:证据生成的挑战
Clinical Trials Using Mesenchymal Stem Cells for Spinal Cord Injury: Challenges in Generating Evidence.
机构信息
Institute of Advanced Systems in Health, Senai Cimatec, Salvador 41650-010, BA, Brazil.
Gonçalo Moniz Institute, Oswaldo Cruz Foundation (FIOCRUZ), Salvador 40296-710, BA, Brazil.
出版信息
Cells. 2022 Mar 17;11(6):1019. doi: 10.3390/cells11061019.
Spinal cord injury (SCI) remains an important public health problem which often causes permanent loss of muscle strength, sensation, and function below the site of the injury, generating physical, psychological, and social impacts throughout the lives of the affected individuals, since there are no effective treatments available. The use of stem cells has been investigated as a therapeutic approach for the treatment of SCI. Although a significant number of studies have been conducted in pre-clinical and clinical settings, so far there is no established cell therapy for the treatment of SCI. One aspect that makes it difficult to evaluate the efficacy is the heterogeneity of experimental designs in the clinical trials that have been published. Cell transplantation methods vary widely among the trials, and there are still no standardized protocols or recommendations for the therapeutic use of stem cells in SCI. Among the different cell types, mesenchymal stem/stromal cells (MSCs) are the most frequently tested in clinical trials for SCI treatment. This study reviews the clinical applications of MSCs for SCI, focusing on the critical analysis of 17 clinical trials published thus far, with emphasis on their design and quality. Moreover, it highlights the need for more evidence-based studies designed as randomized controlled trials and potential challenges to be addressed in context of stem cell therapies for SCI.
脊髓损伤(SCI)仍然是一个重要的公共卫生问题,它常常导致损伤部位以下的肌肉力量、感觉和功能永久丧失,给受影响个体的生活带来身体、心理和社会方面的影响,因为目前尚无有效的治疗方法。干细胞的应用已被研究作为治疗 SCI 的一种方法。尽管在临床前和临床环境中进行了大量研究,但迄今为止,尚无针对 SCI 治疗的既定细胞疗法。其中一个难以评估疗效的方面是已发表的临床试验中实验设计的异质性。细胞移植方法在试验中差异很大,并且在 SCI 中治疗性使用干细胞仍然没有标准化的方案或建议。在不同的细胞类型中,间充质干细胞(MSCs)是在 SCI 治疗的临床试验中最常被测试的细胞类型。本研究综述了 MSCs 在 SCI 中的临床应用,重点对迄今为止发表的 17 项临床试验进行了批判性分析,重点关注其设计和质量。此外,它强调了需要更多基于证据的研究设计为随机对照试验,并在干细胞治疗 SCI 的背景下解决潜在的挑战。