Chugan G S, Lyundup A V, Bondarenko O N, Galstyan G R
Endocrinology Research Centre.
Endocrinology Research Centre; Research and Educational Resource Center for Cellular Technologies, Peoples' Friendship University of Russia (RUDN University).
Probl Endokrinol (Mosk). 2024 Sep 15;70(4):4-14. doi: 10.14341/probl13481.
The number of patients with diabetes mellitus (DM) has been progressively increasing worldwide over the past decades, and many international organizations consider DM as a public health emergency of the 21st century.Critical limb ischemia (CLI) is the most severe stage of peripheral arterial disease (PAD) in DM and is characterized by a high risk of limb loss without revascularization. Traditional treatment tactics include open and endovascular revascularization surgical techniques. However, in patients not eligible for revascularization and in cases where performed surgical treatment performed has been ineffective, there are almost no therapeutic alternatives, often leading to amputations and death. As of today, one of the newest non-surgical treatment options is cell therapy. Among different cells, mesenchymal stromal cells (MSCs) are potentially one of the most prospective for use in this patient population.This article provides an overview of clinical trials using cell therapy in patients with CLI.To analyze publications, electronic databases PubMed, SCOPUS, ClinicalTrials, and ScienceDirect were searched to identify published data from clinical trials, research studies, and review articles on cell therapy for critical lower extremity ischemia. After the search, 489 results were received.As a result of systematic selection, 22 clinical trials were analyzed.According to the analyzed literature data, the use of cell products in this category of patients is effective and safe. Cell therapy can stimulate the formation of new vessels and enhances collateral circulation; it is also reported improved distal perfusion, increased pain-free walking distance, decreased amputation rates, and increased survival rates.Nevertheless, further study of the potential use of this category of drugs is needed.
在过去几十年中,全球糖尿病患者的数量一直在逐步增加,许多国际组织将糖尿病视为21世纪的公共卫生紧急情况。严重肢体缺血(CLI)是糖尿病外周动脉疾病(PAD)最严重的阶段,其特征是在没有血管重建的情况下肢体丧失的风险很高。传统的治疗策略包括开放和血管腔内血管重建手术技术。然而,对于不符合血管重建条件的患者以及手术治疗无效的情况,几乎没有其他治疗选择,这往往导致截肢和死亡。截至目前,最新的非手术治疗选择之一是细胞疗法。在不同的细胞中,间充质基质细胞(MSCs)可能是最有前景用于这类患者的细胞之一。本文概述了在CLI患者中使用细胞疗法的临床试验。为了分析相关出版物,检索了电子数据库PubMed、SCOPUS、ClinicalTrials和ScienceDirect,以识别来自临床试验、研究以及关于严重下肢缺血细胞疗法的综述文章的已发表数据。检索后,共获得489条结果。经过系统筛选,分析了22项临床试验。根据分析的文献数据,在这类患者中使用细胞产品是有效且安全的。细胞疗法可以刺激新血管的形成并增强侧支循环;据报道,它还能改善远端灌注、增加无痛步行距离、降低截肢率并提高生存率。尽管如此,仍需要进一步研究这类药物的潜在用途。