Agosti Edoardo, Zeppieri Marco, Pagnoni Andrea, Fontanella Marco Maria, Fiorindi Alessandro, Ius Tamara, Panciani Pier Paolo
Division of Neu rosurgery, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Brescia 25123, Italy.
Department of Ophthalmology, University Hospital of Udine, Udine 33100, Italy.
World J Transplant. 2024 Mar 18;14(1):89674. doi: 10.5500/wjt.v14.i1.89674.
Previous assessments of stem cell therapy for spinal cord injuries (SCI) have encountered challenges and constraints. Current research primarily emphasizes safety in early-phase clinical trials, while systematic reviews prioritize effectiveness, often overlooking safety and translational feasibility. This situation prompts inquiries regarding the readiness for clinical adoption.
To offer an up-to-date systematic literature review of clinical trial results con cerning stem cell therapy for SCI.
A systematic search was conducted across major medical databases [PubMed, Embase, Reference Citation Analysis (RCA), and Cochrane Library] up to October 14, 2023. The search strategy utilized relevant Medical Subject Heading (MeSH) terms and keywords related to "spinal cord", "injury", "clinical trials", "stem cells", "functional outcomes", and "adverse events". Studies included in this review consisted of randomized controlled trials and non-randomized controlled trials reporting on the use of stem cell therapies for the treatment of SCI.
In a comprehensive review of 66 studies on stem cell therapies for SCI, 496 papers were initially identified, with 237 chosen for full-text analysis. Among them, 236 were deemed eligible after excluding 170 for various reasons. These studies encompassed 1086 patients with varying SCI levels, with cervical injuries being the most common (42.2%). Bone marrow stem cells were the predominant stem cell type used (71.1%), with various administration methods. Follow-up durations averaged around 84.4 months. The 32.7% of patients showed functional impro vement from American spinal injury association Impairment Scale (AIS) A to B, 40.8% from AIS A to C, 5.3% from AIS A to D, and 2.1% from AIS B to C. Sensory improvements were observed in 30.9% of patients. A relatively small number of adverse events were recorded, including fever (15.1%), headaches (4.3%), muscle tension (3.1%), and dizziness (2.6%), highlighting the potential for SCI recovery with stem cell therapy.
In the realm of SCI treatment, stem cell-based therapies show promise, but clinical trials reveal potential adverse events and limitations, underscoring the need for meticulous optimization of transplantation conditions and parameters, caution against swift clinical implementation, a deeper understanding of SCI pathophysiology, and addressing ethical, tumorigenicity, immunogenicity, and immunotoxicity concerns before gradual and careful adoption in clinical practice.
先前对脊髓损伤(SCI)干细胞疗法的评估面临挑战和限制。当前研究在早期临床试验中主要强调安全性,而系统评价则侧重于有效性,常常忽视安全性和转化可行性。这种情况引发了对临床应用准备情况的质疑。
提供关于SCI干细胞疗法临床试验结果的最新系统文献综述。
截至2023年10月14日,在主要医学数据库[PubMed、Embase、参考文献引用分析(RCA)和Cochrane图书馆]中进行了系统检索。检索策略使用了与“脊髓”、“损伤”、“临床试验”、“干细胞”、“功能结局”和“不良事件”相关的医学主题词(MeSH)和关键词。本综述纳入的研究包括报告使用干细胞疗法治疗SCI的随机对照试验和非随机对照试验。
在对66项SCI干细胞疗法研究的全面综述中,最初识别出496篇论文,选择237篇进行全文分析。其中,因各种原因排除170篇后,236篇被认为符合要求。这些研究涵盖1086例SCI程度各异的患者,其中颈部损伤最为常见(42.2%)。骨髓干细胞是使用的主要干细胞类型(71.1%),采用了多种给药方法。随访时间平均约84.4个月。32.7%的患者美国脊髓损伤协会损伤量表(AIS)从A级改善到B级,40.8%从A级改善到C级,5.3%从A级改善到D级,2.1%从B级改善到C级。30.9%的患者出现感觉改善。记录到的不良事件相对较少,包括发热(15.1%)、头痛(4.3%)、肌肉紧张(3.1%)和头晕(2.6%),突出了干细胞疗法促进SCI恢复的潜力。
在SCI治疗领域,基于干细胞的疗法显示出前景,但临床试验揭示了潜在的不良事件和局限性,强调需要精心优化移植条件和参数,谨慎对待迅速的临床实施,更深入地了解SCI病理生理学,并在临床实践中逐步谨慎采用之前解决伦理、致瘤性、免疫原性和免疫毒性问题。