title: Safety and therapeutic effect of mesenchymal stem cell infusion on moderate to severe ulcerative colitis.
abstract: One of the primary targets of the clinical treatment of ulcerative colitis (UC) is to repair the damaged colonic mucosa. Mesenchymal stem cells (MSCs) have therapeutic potential in regenerative medicine due to their differentiation capacity and their secretion of numerous bioactive molecules. The present study describes a clinical trial (trial registration no. NCT01221428) investigating the safety and therapeutic effect of MSCs derived from human umbilical cord on moderate to severe UC. Thirty-four patients with UC were included in groupIand treated with MSC infusion in addition to the base treatment, and thirty-six patients were in groupIIand treated with normal saline in addition to the base treatment. One month after therapy, 30/36 patients in groupIshowed good response, and diffuse and deep ulcer formation and severe inflammatory mucosa were improved markedly. During the follow up, the median Mayo score and histology score in groupIwere decreased while IBDQ scores were significantly improved compared with before treatment and groupII (P<0.05). Compared with groupII, there were no evident adverse reactions after MSC infusion in any of the patients in groupI, and no chronic side effects or lingering effects appeared during the follow-up period. In conclusion, MSC infusion might be a useful and safe therapy for treating UC.
authors.affiliation: Stem Cell Research Center, The Affiliated Hospital of Qingdao University, Qingdao, Shandong 266003, P.R. China.
authors.forename: Jianxia
authors.initials: J
authors.lastname: Hu
authors.affiliation: Anorectal Department, The Affiliated Hospital of Qingdao University, Qingdao, Shandong 266003, P.R. China.
authors.forename: Gang
authors.initials: G
authors.lastname: Zhao
authors.affiliation: Anorectal Department, The Affiliated Hospital of Qingdao University, Qingdao, Shandong 266003, P.R. China.
authors.forename: Lize
authors.initials: L
authors.lastname: Zhang
authors.affiliation: Anorectal Department, The Affiliated Hospital of Qingdao University, Qingdao, Shandong 266003, P.R. China.
authors.forename: Cuixia
authors.initials: C
authors.lastname: Qiao
authors.affiliation: Anorectal Department, The Affiliated Hospital of Qingdao University, Qingdao, Shandong 266003, P.R. China.
authors.forename: Aiping
authors.initials: A
authors.lastname: Di
authors.affiliation: Stem Cell Research Center, The Affiliated Hospital of Qingdao University, Qingdao, Shandong 266003, P.R. China.
authors.forename: Hong
authors.initials: H
authors.lastname: Gao
authors.affiliation: Endoscopy Center, The First Affiliated Hospital of Jilin University, Changchun, Jilin 130000, P.R. China.
authors.forename: Hong
authors.initials: H
authors.lastname: Xu
keywords: cell therapy; immune regulation; mesenchymal stem cells; mucosal healing; ulcerative colitis