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 

作者机构：Department of Colorectal SurgeryColorectal Research CenterImam Khomeini Hospital ComplexTehran University of Medical SciencesTehranIran Department of Biomedical EngineeringSchool of Biomedical EngineeringUniversity of Technology SydneySydneyNSWAustralia Department of GastroenterologyDivision of GastroenterologyImam Khomeini HospitalSchool of MedicineTehran University of Medical SciencesTehranIran Department of Cardiovascular SurgeryResearch Center for Advanced Technologies in Cardiovascular MedicineCardiovascular Research InstituteTehran University of Medical SciencesTehranIran Division of Colorectal SurgeryDepartment of SurgeryTehran University of Medical SciencesTehranIran Department of Cell Therapy and HematologyFaculty of Medical SciencesTarbiat Modares UniversityTehranIran Department of Tissue Engineering and Applied Cell SciencesSchool of Advanced Technologies in MedicineStudent Research CommitteeShahid Beheshti University of Medical SciencesTehranIran 

出 版 物：《Gastroenterology Report》 (胃肠病学报道（英文）)

年 卷 期：2022年第10卷第1期

页      面：585-593页

核心收录：

学科分类：1002[医学-临床医学] 100210[医学-外科学(含：普外、骨外、泌尿外、胸心外、神外、整形、烧伤、野战外)] 10[医学] 

主　　题：IBD exosome Crohn’s disease MSCs fistula 

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 *** study aimed to assess the safety and efficacy of usingmesenchymal stemcell(MSC)exosomes to treat refractory fistulas in patients with inflammatory bowel ***:MSCs were derived from the umbilical cords and their exosomes were *** patients with refractory perianal Crohn’s disease fistulas with amedian age of 35 years(range 31–47 years)were enrolled in the *** 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 ***:The outcomes within 6 months after initiation of therapy showed that four patients had responded to *** patients who received exosome injections exhibited complete healing,while one reported no improvement and active discharge from the fistula *** addition,five patients(100%)reported neither systemic nor local adverse ***: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.