Copyright
©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
Effectiveness and safety of human umbilical cord-mesenchymal stem cells for treating type 2 diabetes mellitus
Xiao-Fen Lian, Dong-Hui Lu, Hong-Li Liu, Yan-Jing Liu, Xiu-Qun Han, Yang Yang, Yuan Lin, Qing-Xiang Zeng, Zheng-Jie Huang, Feng Xie, Cai-Hao Huang, Hong-Mei Wu, Ai-Mei Long, Ling-Ping Deng, Fan Zhang
Xiao-Fen Lian, Dong-Hui Lu, Hong-Li Liu, Yan-Jing Liu, Yuan Lin, Qing-Xiang Zeng, Zheng-Jie Huang, Feng Xie, Cai-Hao Huang, Fan Zhang, Department of Endocrinology, Peking University Shenzhen Hospital, Shenzhen 518000, Guangdong Province, China
Xiu-Qun Han, Department of Research & Development, Zhejiang MaiDa Gene Tech Co. Ltd, Zhoushan 316000, Zhejiang Province, China
Yang Yang, Department of Endocrinology, Huizhou Central People's Hospital, Huizhou 516000, Guangdong Province, China
Hong-Mei Wu, Ai-Mei Long, Ling-Ping Deng, 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 YL, Yang Y, Lin Y, Zeng QX, Huang ZJ, Xie F, Huang CH, Wu HM, Long AM, and Deng LP collected the patient’s clinical data; Lian XF and Han XQ analyzed the data and wrote the paper.
Supported by Shenzhen Science and Technology Innovation Committee Projects, No. JCYJ20170816105416349; Shenzhen High-level Hospital Construction Fund; and 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 enrolled from patients admitted to Peking University Shenzhen Hospital for diabetes mellitus and all had signed informed consent.
Conflict-of-interest statement: The authors have no conflicts of interest to declare.
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, No. 1120 Lianhua Road, Futian District, Shenzhen 518000, Guangdong Province, China.
bjdxszyynfm@163.com
Received: June 6, 2022
Peer-review started: June 6, 2022
First decision: August 7, 2022
Revised: August 19, 2022
Accepted: September 8, 2022
Article in press: September 8, 2022
Published online: October 15, 2022
Processing time: 130 Days and 7.7 Hours
ARTICLE HIGHLIGHTS
Research background
Cellular therapies offer novel opportunities for the treatment of type 2 diabetes mellitus (T2DM) to improve the function of islet β-cells. However, the effectiveness and safety of human umbilical cord-mesenchymal stem cell (hUC-MSCs) in clinical application have not been fully assessed.
Research motivation
We conducted the present trial to explore the therapeutic effectiveness and mechanism of hUC-MSC infusion for treating T2DM.
Research objectives
We hypothesized that hUC-MSCs restore β-cell function by differentiating into β-cells. We conducted the present trial to treat T2DM with hUC-MSC infusion and evaluated the effectiveness and safety of hUC-MSC therapy.
Research methods
Patients were enrolled and received 1 × 106 cells/kg per week for 3 wk of intravenous hUC-MSC infusion. The effectiveness was assessed by fasting blood glucose, C-peptide, normal glycosylated hemoglobin A1c level (HbA1c), insulin resistance (IR) index (homeostasis model assessment of insulin resistance), islet β-cell function (homeostasis model assessment of β-cell function), and dosage of hypoglycemic agents, and the safety was evaluated by monitoring the occurrence of any adverse events.
Research results
During the entire intervention period, the fasting plasma glucose level and HbA1c were significantly reduced. The patients’ islet β-cell function was significantly improved, and the dosage of hypoglycemic agents was reduced in all patients without serious adverse events.
Research conclusions
We hypothesize that hUC-MSCs restore β-cell function by differentiating into β-cells. Our study suggests that hUC-MSC treatment can improve glycemia, restore islet βcell function, and safely reduce the dosage of hypoglycemic agents.
Research perspectives
Islet β-cell function and IR state of the patients in this study will be extensively followed for further analysis to elucidate the mechanisms underlying glycemia improvement.
