Feizi Hamidreza, Hosseini Mohammad-Salar, Seyedi-Sahebari Sepideh, Karimi Hanie, Mosaddeghi-Heris Reza, Sadigh-Eteghad Saeed, Sadeghi-Ghyassi Fatemeh, Talebi Mahnaz, Naseri Amirreza, Salehi-Pourmehr Hanieh, Roshangar Leila
Tabriz University of Medical Sciences, Student Research Committee, Tabriz, Iran. Tabriz University of Medical Sciences Student Research Committee Tabriz Iran.
Tabriz University of Medical Sciences, Aging Research Institute, Research Center for Integrative Medicine in Aging, Tabriz, Iran. Tabriz University of Medical Sciences Aging Research Institute Research Center for Integrative Medicine in Aging Tabriz Iran.
Dement Neuropsychol. 2024 Sep 6;18:e20240147. doi: 10.1590/1980-5764-DN-2024-0147. eCollection 2024.
There is presently no disease-modifying therapy for Alzheimer's Disease (AD), which is the most prevalent cause of dementia.
This study aspires to estimate the efficacy and safety of cell-based treatments in AD.
Observing the Joanna Briggs Institute (JBI) methods and Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement, a systematic search was accomplished in PubMed, Medical Literature Analysis and Retrieval System Online (Medline, via Ovid), Embase; Cochrane, and Cumulative Index of Nursing and Allied Health Literature - CINAHL (via EBSCO) databases up to June 2023. The relevant clinical studies in which cell-based therapies were utilized to manage AD were included. The risk of bias was evaluated using the JBI checklists, based on the study designs.
Out of 1,014 screened records, a total of five studies with 70 individuals (including 59 patients receiving stem cells and 11 placebo controls) were included. In all these studies, despite the discrepancy in the origin of stem cells, cell density, and transplant site, safety goals were obtained. The intracerebroventricular injection of adipose-derived stromal vascular fraction (ADSVF) and umbilical cord-derived mesenchymal stem cells (UC-MSCs), the intravenous injection of Lomecel-B, and the bilateral hippocampi and right precuneus injection of UC-MSCs are not linked to any significant safety concerns, according to the five included studies. Studies also revealed improvements in biomarkers and clinical outcomes as a secondary outcome. Three studies had no control groups and there are concerns regarding the similarity of the groups in others. Also, there is considerable risk of bias regarding the outcome assessment scales.
Cell-based therapies are well tolerated by AD patients, which emphasizes the need for further, carefully planned randomized studies to reach evidence-based clinical recommendations in this respect.
目前尚无针对阿尔茨海默病（AD）的疾病修饰疗法，而AD是痴呆最常见的病因。
本研究旨在评估基于细胞的治疗方法对AD的疗效和安全性。
遵循乔安娜·布里格斯研究所（JBI）方法和系统评价与Meta分析的首选报告项目（PRISMA）声明，截至2023年6月，在PubMed、医学文献分析和在线检索系统（通过Ovid的Medline）、Embase、Cochrane以及护理及相关健康文献累积索引 - CINAHL（通过EBSCO）数据库中进行了系统检索。纳入了使用基于细胞的疗法治疗AD的相关临床研究。根据研究设计，使用JBI清单评估偏倚风险。
在筛选的1014条记录中，共纳入了五项研究，涉及70名个体（包括59名接受干细胞治疗的患者和11名安慰剂对照）。在所有这些研究中，尽管干细胞来源、细胞密度和移植部位存在差异，但均实现了安全目标。根据纳入的五项研究，脑室内注射脂肪来源的基质血管成分（ADSVF）和脐带间充质干细胞（UC-MSC）、静脉注射Lomecel-B以及双侧海马和右楔前叶注射UC-MSC均未引发任何重大安全问题。研究还显示生物标志物和临床结局作为次要结局有所改善。三项研究没有对照组，其他研究中组间相似性也存在问题。此外，结局评估量表存在相当大的偏倚风险。
AD患者对基于细胞的疗法耐受性良好，这强调需要进一步开展精心规划的随机研究，以在此方面得出基于证据的临床建议。
