Clinical Trials Study
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Jul 26, 2023; 11(21): 5083-5096
Published online Jul 26, 2023. doi: 10.12998/wjcc.v11.i21.5083
Safety evaluation of human umbilical cord-mesenchymal stem cells in type 2 diabetes mellitus treatment: A phase 2 clinical trial
Xiao-Fen Lian, Dong-Hui Lu, Hong-Li Liu, Yan-Jing Liu, Yang Yang, Yuan Lin, Feng Xie, Cai-Hao Huang, Hong-Mei Wu, Ai-Mei Long, Chen-Jun Hui, Yu Shi, Yun Chen, Yun-Feng Gao, Fan Zhang
Xiao-Fen Lian, Dong-Hui Lu, Hong-Li Liu, Yan-Jing Liu, Yuan Lin, Feng Xie, Cai-Hao Huang, Chen-Jun Hui, Yu Shi, Yun Chen, Yun-Feng Gao, Fan Zhang, Department of Endocrinology, Peking University Shenzhen Hospital, Shenzhen 518000, Guangdong Province, China
Yang Yang, Department of Endocrinology, Huizhou Central People’s Hospital, Huizhou 516000, Guangdong Province, China
Hong-Mei Wu, Ai-Mei Long, Department of Endocrinology, Longgang District Central Hospital of Shenzhen, Shenzhen 518000, Guangdong Province, China
Author contributions: Zhang F designed the report; Lian XF, Lu DH, Liu HL, Liu YJ, Yang Y, Lin Y, Xie F, Huang CH, Wu HM, Long AM, Hui CJ, Shi Y, and Chen Y collected the patients’ clinical data; Hui CJ provided cell technical support; Lian XF analyzed the data and wrote the paper; and all authors read and approved the final version of the manuscript.
Supported by Shenzhen Science and Technology Innovation Committee Projects, No. JCYJ20170816105416349; and Shenzhen High-Level Hospital Construction Fund, Shenzhen Key Medical Discipline Construction Fund, No. SZXK010.
Institutional review board statement: This study was approved by the Ethics Committee of the Ethical Committee of the Peking University Shenzhen Hospital [IRB of Peking University Shenzhen Hospital (2018) 29th].
Clinical trial registration statement: This study is registered in the Chinese Clinical Trial Registry, Registration No. ChiCTR2200057370.
Informed consent statement: The participants were recruited and enrolled from among patients admitted to Peking University Shenzhen Hospital for diabetes mellitus, and all provided written informed consent.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: There are no additional data.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Fan Zhang, MD, Doctor, Department of Endocrinology, Peking University Shenzhen Hospital, LianHua Road, Shenzhen 518000, Guangdong Province, China. bjdxszyynfm@163.com
Received: March 17, 2023
Peer-review started: March 17, 2023
First decision: April 11, 2023
Revised: May 23, 2023
Accepted: June 16, 2023
Article in press: June 16, 2023
Published online: July 26, 2023
Processing time: 131 Days and 22.8 Hours
Core Tip

Core Tip: Diabetes mellitus is a major public health problem worldwide. Type 2 diabetes mellitus is regarded as a chronic progressive disease that arises from an impairment in the insulin-sensing mechanisms culminating in insulin resistance. Our article focused on the safety of human umbilical cord mesenchymal stem cell infusion for treating type 2 diabetes mellitus. The results suggested that human umbilical cord mesenchymal stem cell treatment can impact human immunity and inhibit lymphocytes. We should pay attention to its influence on coagulation.