PMID- 37583846 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230817 IS - 2307-8960 (Print) IS - 2307-8960 (Electronic) IS - 2307-8960 (Linking) VI - 11 IP - 21 DP - 2023 Jul 26 TI - Safety evaluation of human umbilical cord-mesenchymal stem cells in type 2 diabetes mellitus treatment: A phase 2 clinical trial. PG - 5083-5096 LID - 10.12998/wjcc.v11.i21.5083 [doi] AB - BACKGROUND: Progressive pancreatic beta cell dysfunction is a fundamental aspect of the pathology underlying type 2 diabetes mellitus (T2DM). Recently, mesenchymal stem cell (MSC) transplantation has emerged as a new therapeutic method due to its ability to promote the regeneration of pancreatic beta cells. However, current studies have focused on its efficacy, and there are few clinical studies on its safety. AIM: To evaluate the safety of human umbilical cord (hUC)-MSC infusion in T2DM treatment. METHODS: An open-label and randomized phase 2 clinical trial was designed to evaluate the safety of hUC-MSC transplantation in T2DM in a Class A hospital. Ten patients in the placebo group received acellular saline intravenously once per week for 3 wk. Twenty-four patients in the hUC-MSC group received hUC-MSCs (1 x 10(6) cells/kg) intravenously once per week for 3 wk. Diabetic clinical symptoms and signs, laboratory findings, and imaging findings were evaluated weekly for the 1(st) mo and then at weeks 12 and 24 post-treatment. RESULTS: No serious adverse events were observed during the 24-wk follow-up. Four patients (16.7%) in the hUC-MSC group experienced transient fever, which occurred within 24 h after the second or third infusion; this did not occur in any patients in the placebo group. One patient from the hUC-MSC group experienced hypoglycemic attacks within 1 mo after transplantation. Significantly lower lymphocyte levels (weeks 2 and 3) and thrombin coagulation time (week 2) were observed in the hUC-MSC group compared to those in the placebo group (all P < 0.05). Significantly higher platelet levels (week 3), immunoglobulin levels (weeks 1, 2, 3, and 4), fibrinogen levels (weeks 2 and 3), D-dimer levels (weeks 1, 2, 3, 4, 12, and 24), and neutrophil-to-lymphocyte ratios (weeks 2 and 3) were observed in the hUC-MSC group compared to those in the placebo group (all P < 0.05). There were no significant differences between the two groups for tumor markers (alpha-fetoprotein, carcinoembryonic antigen, and carbohydrate antigen 199) or blood fat. No liver damage or other side effects were observed on chest X-ray. CONCLUSION: Our study suggested that hUC-MSC transplantation has good tolerance and high safety in the treatment of T2DM. It can improve human immunity and inhibit lymphocytes. Coagulation function should be monitored vigilantly for abnormalities. CI - (c)The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved. FAU - Lian, Xiao-Fen AU - Lian XF AD - Department of Endocrinology, Peking University Shenzhen Hospital, Shenzhen 518000, Guangdong Province, China. FAU - Lu, Dong-Hui AU - Lu DH AD - Department of Endocrinology, Peking University Shenzhen Hospital, Shenzhen 518000, Guangdong Province, China. FAU - Liu, Hong-Li AU - Liu HL AD - Department of Endocrinology, Peking University Shenzhen Hospital, Shenzhen 518000, Guangdong Province, China. FAU - Liu, Yan-Jing AU - Liu YJ AD - Department of Endocrinology, Peking University Shenzhen Hospital, Shenzhen 518000, Guangdong Province, China. FAU - Yang, Yang AU - Yang Y AD - Department of Endocrinology, Huizhou Central People's Hospital, Huizhou 516000, Guangdong Province, China. FAU - Lin, Yuan AU - Lin Y AD - Department of Endocrinology, Peking University Shenzhen Hospital, Shenzhen 518000, Guangdong Province, China. FAU - Xie, Feng AU - Xie F AD - Department of Endocrinology, Peking University Shenzhen Hospital, Shenzhen 518000, Guangdong Province, China. FAU - Huang, Cai-Hao AU - Huang CH AD - Department of Endocrinology, Peking University Shenzhen Hospital, Shenzhen 518000, Guangdong Province, China. FAU - Wu, Hong-Mei AU - Wu HM AD - Department of Endocrinology, Longgang District Central Hospital of Shenzhen, Shenzhen 518000, Guangdong Province, China. FAU - Long, Ai-Mei AU - Long AM AD - Department of Endocrinology, Longgang District Central Hospital of Shenzhen, Shenzhen 518000, Guangdong Province, China. FAU - Hui, Chen-Jun AU - Hui CJ AD - Department of Endocrinology, Peking University Shenzhen Hospital, Shenzhen 518000, Guangdong Province, China. FAU - Shi, Yu AU - Shi Y AD - Department of Endocrinology, Peking University Shenzhen Hospital, Shenzhen 518000, Guangdong Province, China. FAU - Chen, Yun AU - Chen Y AD - Department of Endocrinology, Peking University Shenzhen Hospital, Shenzhen 518000, Guangdong Province, China. FAU - Gao, Yun-Feng AU - Gao YF AD - Department of Endocrinology, Peking University Shenzhen Hospital, Shenzhen 518000, Guangdong Province, China. FAU - Zhang, Fan AU - Zhang F AD - Department of Endocrinology, Peking University Shenzhen Hospital, Shenzhen 518000, Guangdong Province, China. bjdxszyynfm@163.com. LA - eng PT - Clinical Trial PL - United States TA - World J Clin Cases JT - World journal of clinical cases JID - 101618806 PMC - PMC10424020 OTO - NOTNLM OT - Cell transplantation OT - Human umbilical cord-mesenchymal stem cells OT - Immunity OT - Lymphocytes OT - Safety OT - Type 2 diabetes mellitus COIS- Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article. EDAT- 2023/08/16 06:43 MHDA- 2023/08/16 06:44 PMCR- 2023/07/26 CRDT- 2023/08/16 03:53 PHST- 2023/03/17 00:00 [received] PHST- 2023/05/23 00:00 [revised] PHST- 2023/06/16 00:00 [accepted] PHST- 2023/08/16 06:44 [medline] PHST- 2023/08/16 06:43 [pubmed] PHST- 2023/08/16 03:53 [entrez] PHST- 2023/07/26 00:00 [pmc-release] AID - 10.12998/wjcc.v11.i21.5083 [doi] PST - ppublish SO - World J Clin Cases. 2023 Jul 26;11(21):5083-5096. doi: 10.12998/wjcc.v11.i21.5083.