Evaluating the safety and efficacy of mesenchymal stem cell-derived exosomes for treatment of refractory perianal fistula in IBD patients:clinical trial phaseⅠ  

作　　者：Hojjatollah Nazari Foroogh Alborzi Asieh Heirani-Tabasi Alireza Hadizadeh Reza Akbari Asbagh Behnam Behboudi Mohammad Sadegh Fazeli Mojgan Rahimi Mohammad Reza Keramati Amir Keshvari Alireza Kazemeini Masoud Soleimani Seyed Mohsen Ahmadi Tafti 

机构地区：[1]Department of Colorectal Surgery,Colorectal Research Center,Imam Khomeini Hospital Complex,Tehran University of Medical Sciences,Tehran,Iran [2]Department of Biomedical Engineering,School of Biomedical Engineering,University of Technology Sydney,Sydney,NSW,Australia [3]Department of Gastroenterology,Division of Gastroenterology,Imam Khomeini Hospital,School of Medicine,Tehran University of Medical Sciences,Tehran,Iran [4]Department of Cardiovascular Surgery,Research Center for Advanced Technologies in Cardiovascular Medicine,Cardiovascular Research Institute,Tehran University of Medical Sciences,Tehran,Iran [5]Division of Colorectal Surgery,Department of Surgery,Tehran University of Medical Sciences,Tehran,Iran [6]Department of Cell Therapy and Hematology,Faculty of Medical Sciences,Tarbiat Modares University,Tehran,Iran [7]Department of Tissue Engineering and Applied Cell Sciences,School of Advanced Technologies in Medicine,Student Research Committee,Shahid Beheshti University of Medical Sciences,Tehran,Iran

出　　处：《Gastroenterology Report》2022年第1期585-593,共9页胃肠病学报道（英文）

摘　　要：Background:Exosome administration is a novel medical approach that promises excellent immunomodulatory properties without the conventional side effects of current antitumor necrosis factor drugs and stemcells.This study aimed to assess the safety and efficacy of usingmesenchymal stemcell(MSC)exosomes to treat refractory fistulas in patients with inflammatory bowel disease.Methods:MSCs were derived from the umbilical cords and their exosomes were isolated.Five patients with refractory perianal Crohn’s disease fistulas with amedian age of 35 years(range 31–47 years)were enrolled in the study.Exosome injections were administered in the operating roomto patients with refractory fistula(fistulas that are irresponsive to anti-tumor necrosis factor-αadministration within 6months).Sixmonths later,a physical examination,face-to-face interviews,andmagnetic resonance imaging were employed to evaluate the therapy responses of patients.Results:The outcomes within 6 months after initiation of therapy showed that four patients had responded to therapy.Three patients who received exosome injections exhibited complete healing,while one reported no improvement and active discharge from the fistula site.In addition,five patients(100%)reported neither systemic nor local adverse effects.Conclusions:Injection of exosomes extracted from MSCs demonstrates safety and a satisfactory therapeutic effect,as evidenced in this and other studies,and may play a significant role in the future treatment of gastrointestinal fistulas.

关 键 词：IBD EXOSOME Crohn’s disease MSCs FISTULA 

分 类 号：R657.1[医药卫生—外科学]