{"title":"细胞疗法在阿尔茨海默病中的临床疗效和安全性系统回顾。","authors":"Hamidreza Feizi, Mohammad-Salar Hosseini, Sepideh Seyedi-Sahebari, Hanie Karimi, Reza Mosaddeghi-Heris, Saeed Sadigh-Eteghad, Fatemeh Sadeghi-Ghyassi, Mahnaz Talebi, Amirreza Naseri, Hanieh Salehi-Pourmehr, Leila Roshangar","doi":"10.1590/1980-5764-DN-2024-0147","DOIUrl":null,"url":null,"abstract":"<p><p>There is presently no disease-modifying therapy for Alzheimer's Disease (AD), which is the most prevalent cause of dementia.</p><p><strong>Objective: </strong>This study aspires to estimate the efficacy and safety of cell-based treatments in AD.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":39167,"journal":{"name":"Dementia e Neuropsychologia","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2024-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11386524/pdf/","citationCount":"0","resultStr":"{\"title\":\"A systematic review of clinical efficacy and safety of cell-based therapies in Alzheimer's disease.\",\"authors\":\"Hamidreza Feizi, Mohammad-Salar Hosseini, Sepideh Seyedi-Sahebari, Hanie Karimi, Reza Mosaddeghi-Heris, Saeed Sadigh-Eteghad, Fatemeh Sadeghi-Ghyassi, Mahnaz Talebi, Amirreza Naseri, Hanieh Salehi-Pourmehr, Leila Roshangar\",\"doi\":\"10.1590/1980-5764-DN-2024-0147\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>There is presently no disease-modifying therapy for Alzheimer's Disease (AD), which is the most prevalent cause of dementia.</p><p><strong>Objective: </strong>This study aspires to estimate the efficacy and safety of cell-based treatments in AD.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>\",\"PeriodicalId\":39167,\"journal\":{\"name\":\"Dementia e Neuropsychologia\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-09-06\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11386524/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Dementia e Neuropsychologia\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1590/1980-5764-DN-2024-0147\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q3\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Dementia e Neuropsychologia","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1590/1980-5764-DN-2024-0147","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/1/1 0:00:00","PubModel":"eCollection","JCR":"Q3","JCRName":"Medicine","Score":null,"Total":0}
A systematic review of clinical efficacy and safety of cell-based therapies in Alzheimer's disease.
There is presently no disease-modifying therapy for Alzheimer's Disease (AD), which is the most prevalent cause of dementia.
Objective: This study aspires to estimate the efficacy and safety of cell-based treatments in AD.
Methods: 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.
Results: 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.
Conclusion: 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.
期刊介绍：
Dementia top Neuropsychologia the official scientific journal of the Cognitive Neurology and Ageing Department of the Brazilian Academy of Neurology and of the Brazilian Association of Geriatric Neuropsychiatry, is published by the "Associação Neurologia Cognitiva e do Comportamento", a nonprofit Brazilian association. Regularly published on March, June, September, and December since 2007.
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