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
BACKGROUND
Progressive pancreatic β-cell dysfunction is a fundamental part of the pathology of type 2 diabetes mellitus (T2DM). Cellular therapies offer novel opportunities for the treatment of T2DM to improve the function of islet β-cells.
AIM
To evaluate the effectiveness and safety of human umbilical cord-mesenchymal stem cell (hUC-MSC) infusion in T2DM treatment.
METHODS
Sixteen patients were enrolled and received 1 × 106 cells/kg per week for 3 wk as intravenous hUC-MSC infusion. The effectiveness was evaluated by assessing fasting blood glucose, C-peptide, normal glycosylated hemoglobin A1c (HbA1c), insulin resistance index (homeostatic model assessment for insulin resistance), and islet β-cell function (homeostasis model assessment of β-cell function). The dosage of hypoglycemic agents and safety were evaluated by monitoring the occurrence of any adverse events (AEs).
RESULTS
During the entire intervention period, the fasting plasma glucose level was significantly reduced [baseline: 9.3400 (8.3575, 11.7725), day 14 ± 3: 6.5200 (5.2200, 8.6900); P < 0.01]. The HbA1c level was significantly reduced on day 84 ± 3 [baseline: 7.8000 (7.5250, 8.6750), day 84 ± 3: 7.150 (6.600, 7.925); P < 0.01]. The patients’ islet β-cell function was significantly improved on day 28 ± 3 of intervention [baseline: 29.90 (16.43, 37.40), day 28 ± 3: 40.97 (19.27, 56.36); P < 0.01]. The dosage of hypoglycemic agents was reduced in all patients, of whom 6 (50%) had a decrement of more than 50% and 1 (6.25%) discontinued the hypoglycemic agents. Four patients had transient fever, which occurred within 24 h after the second or third infusion. One patient (2.08%) had asymptomatic nocturnal hypoglycemia after infusion on day 28 ± 3. No liver damage or other side effects were reported.
CONCLUSION
The results of this study suggest that hUC-MSC infusion can improve glycemia, restore islet β-cell function, and reduce the dosage of hypoglycemic agents without serious AEs. Thus, hUC-MSC infusion may be a novel option for the treatment of T2DM.
Core Tip: Our article focused on the effectiveness and safety of human umbilical cord mesenchymal stem cell (hUC-MSC) infusion for treating type 2 diabetes. The results suggest that hUC-MSC infusion can improve glycemia, restore islet βcell function, and reduce the dosage of hypoglycemic agents without serious adverse events.
