Repeat-dose toxicity of human umbilical cord mesenchymal stem cells via subcutaneous injection in NOG mice

BackgroundStem cell therapy shows promise for treating skin diseases and enhancing medical aesthetics. However, safety data for subcutaneous injection of stem cells remain limited. In this study, we evaluated the toxicity of human umbilical cord mesenchymal stem cells (hUC-MSCs) in NOD. Cg-Prkdcscid...

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Main Authors: Lijuan Xia, Jinjin Shao, Qian Yang, Chengda Zhang, Zhiqi Xie, Linying Wang, Cong Xu, Siming Zhang, Jing Liu, Fang Liu, Yuhua Shi, Liqiang Gu, Xiaobo Lin, Jiahong Wang, Ying Chen, Yunxiang Chen, Xin Pan, Feifei Wu, Ruolang Pan, Jinfeng Liang, Lijiang Zhang
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-03-01
Series:Frontiers in Cell and Developmental Biology
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Online Access:https://www.frontiersin.org/articles/10.3389/fcell.2025.1558310/full
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author Lijuan Xia
Jinjin Shao
Qian Yang
Chengda Zhang
Zhiqi Xie
Linying Wang
Cong Xu
Siming Zhang
Jing Liu
Jing Liu
Fang Liu
Fang Liu
Yuhua Shi
Liqiang Gu
Xiaobo Lin
Jiahong Wang
Ying Chen
Yunxiang Chen
Xin Pan
Feifei Wu
Ruolang Pan
Jinfeng Liang
Lijiang Zhang
Lijiang Zhang
author_facet Lijuan Xia
Jinjin Shao
Qian Yang
Chengda Zhang
Zhiqi Xie
Linying Wang
Cong Xu
Siming Zhang
Jing Liu
Jing Liu
Fang Liu
Fang Liu
Yuhua Shi
Liqiang Gu
Xiaobo Lin
Jiahong Wang
Ying Chen
Yunxiang Chen
Xin Pan
Feifei Wu
Ruolang Pan
Jinfeng Liang
Lijiang Zhang
Lijiang Zhang
author_sort Lijuan Xia
collection DOAJ
description BackgroundStem cell therapy shows promise for treating skin diseases and enhancing medical aesthetics. However, safety data for subcutaneous injection of stem cells remain limited. In this study, we evaluated the toxicity of human umbilical cord mesenchymal stem cells (hUC-MSCs) in NOD. Cg-PrkdcscidIL2rgtm1Sug/JicCrl (NOG) mice.MethodsMice received subcutaneous hUC-MSC injections at doses of 2.5 × 107 and 2.0 × 108 cells/kg on days 1, 8, 12, 16, and 20, followed by withdrawal and observation for 6 weeks. Toxicity was assessed through clinical observation, behavioral analysis, pathology, organ weight measurements, and histopathology. hUC-MSC distribution was determined via validated quantitative (q)PCR and colonization was assessed using immunohistochemistry.ResultsNo abnormal effects on clinical responses, body weight, or food intake were observed following five repeated hUC-MSCs administrations, except for masses at the administration site in the high-dose group. Mouse activity levels increased in both dose groups 6 h post-final injection. Foamy cells were observed under the pleural membrane in high-dose mice. hUC-MSCs primarily colonized and were distributed within skin tissues 24 h after the last administration.ConclusionThe no-observed-adverse-effect level for subcutaneous hUC-MSC administration in NOG mice over 3 weeks was 2.5 × 107 cells/kg. Our results will help in advancing the clinical use of hUC-MSCs, particularly for treating conditions such as atopic dermatitis.
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spelling doaj-art-e9720f8338274be4bbb97c4493d4eb502025-08-20T02:00:47ZengFrontiers Media S.A.Frontiers in Cell and Developmental Biology2296-634X2025-03-011310.3389/fcell.2025.15583101558310Repeat-dose toxicity of human umbilical cord mesenchymal stem cells via subcutaneous injection in NOG miceLijuan Xia0Jinjin Shao1Qian Yang2Chengda Zhang3Zhiqi Xie4Linying Wang5Cong Xu6Siming Zhang7Jing Liu8Jing Liu9Fang Liu10Fang Liu11Yuhua Shi12Liqiang Gu13Xiaobo Lin14Jiahong Wang15Ying Chen16Yunxiang Chen17Xin Pan18Feifei Wu19Ruolang Pan20Jinfeng Liang21Lijiang Zhang22Lijiang Zhang23Key Laboratory of Drug Safety Evaluation and Research of Zhejiang Province, Center of Safety Evaluation and Research, Hangzhou Medical College, Hangzhou, ChinaKey Laboratory of Drug Safety Evaluation and Research of Zhejiang Province, Center of Safety Evaluation and Research, Hangzhou Medical College, Hangzhou, ChinaKey Laboratory of Drug Safety Evaluation and Research of Zhejiang Province, Center of Safety Evaluation and Research, Hangzhou Medical College, Hangzhou, ChinaKey Laboratory of Drug Safety Evaluation and Research of Zhejiang Province, Center of Safety Evaluation and Research, Hangzhou Medical College, Hangzhou, ChinaWuyi First People’s Hospital, Affiliated Hospital, School of Medicine, Hangzhou City University, Hangzhou, ChinaKey Laboratory of Drug Safety Evaluation and Research of Zhejiang Province, Center of Safety Evaluation and Research, Hangzhou Medical College, Hangzhou, ChinaKey Laboratory of Drug Safety Evaluation and Research of Zhejiang Province, Center of Safety Evaluation and Research, Hangzhou Medical College, Hangzhou, ChinaKey Laboratory of Drug Safety Evaluation and Research of Zhejiang Province, Center of Safety Evaluation and Research, Hangzhou Medical College, Hangzhou, ChinaKey Laboratory of Drug Safety Evaluation and Research of Zhejiang Province, Center of Safety Evaluation and Research, Hangzhou Medical College, Hangzhou, ChinaQingshan Lake Science and Technology Innovation Center, Hangzhou Medical College, Hangzhou, ChinaKey Laboratory of Drug Safety Evaluation and Research of Zhejiang Province, Center of Safety Evaluation and Research, Hangzhou Medical College, Hangzhou, ChinaQingshan Lake Science and Technology Innovation Center, Hangzhou Medical College, Hangzhou, ChinaKey Laboratory of Drug Safety Evaluation and Research of Zhejiang Province, Center of Safety Evaluation and Research, Hangzhou Medical College, Hangzhou, ChinaKey Laboratory of Drug Safety Evaluation and Research of Zhejiang Province, Center of Safety Evaluation and Research, Hangzhou Medical College, Hangzhou, ChinaKey Laboratory of Drug Safety Evaluation and Research of Zhejiang Province, Center of Safety Evaluation and Research, Hangzhou Medical College, Hangzhou, ChinaKey Laboratory of Drug Safety Evaluation and Research of Zhejiang Province, Center of Safety Evaluation and Research, Hangzhou Medical College, Hangzhou, ChinaKey Laboratory of Drug Safety Evaluation and Research of Zhejiang Province, Center of Safety Evaluation and Research, Hangzhou Medical College, Hangzhou, ChinaKey Laboratory of Drug Safety Evaluation and Research of Zhejiang Province, Center of Safety Evaluation and Research, Hangzhou Medical College, Hangzhou, ChinaZhejiang Key Laboratory of Cell-Based Drug and Applied Technology Development, S-Evans Biosciences Co., Ltd., Hangzhou, ChinaZhejiang Key Laboratory of Cell-Based Drug and Applied Technology Development, S-Evans Biosciences Co., Ltd., Hangzhou, ChinaZhejiang Key Laboratory of Cell-Based Drug and Applied Technology Development, S-Evans Biosciences Co., Ltd., Hangzhou, ChinaZhejiang Center for Drugs and Cosmetics Evaluation, Zhejiang Province Food and Drug Administration, Hangzhou, ChinaKey Laboratory of Drug Safety Evaluation and Research of Zhejiang Province, Center of Safety Evaluation and Research, Hangzhou Medical College, Hangzhou, ChinaQingshan Lake Science and Technology Innovation Center, Hangzhou Medical College, Hangzhou, ChinaBackgroundStem cell therapy shows promise for treating skin diseases and enhancing medical aesthetics. However, safety data for subcutaneous injection of stem cells remain limited. In this study, we evaluated the toxicity of human umbilical cord mesenchymal stem cells (hUC-MSCs) in NOD. Cg-PrkdcscidIL2rgtm1Sug/JicCrl (NOG) mice.MethodsMice received subcutaneous hUC-MSC injections at doses of 2.5 × 107 and 2.0 × 108 cells/kg on days 1, 8, 12, 16, and 20, followed by withdrawal and observation for 6 weeks. Toxicity was assessed through clinical observation, behavioral analysis, pathology, organ weight measurements, and histopathology. hUC-MSC distribution was determined via validated quantitative (q)PCR and colonization was assessed using immunohistochemistry.ResultsNo abnormal effects on clinical responses, body weight, or food intake were observed following five repeated hUC-MSCs administrations, except for masses at the administration site in the high-dose group. Mouse activity levels increased in both dose groups 6 h post-final injection. Foamy cells were observed under the pleural membrane in high-dose mice. hUC-MSCs primarily colonized and were distributed within skin tissues 24 h after the last administration.ConclusionThe no-observed-adverse-effect level for subcutaneous hUC-MSC administration in NOG mice over 3 weeks was 2.5 × 107 cells/kg. Our results will help in advancing the clinical use of hUC-MSCs, particularly for treating conditions such as atopic dermatitis.https://www.frontiersin.org/articles/10.3389/fcell.2025.1558310/fullhuman umbilical cord mesenchymal stem cellssubcutaneous injectiontoxicity assessmentNOG micefoamy cells
spellingShingle Lijuan Xia
Jinjin Shao
Qian Yang
Chengda Zhang
Zhiqi Xie
Linying Wang
Cong Xu
Siming Zhang
Jing Liu
Jing Liu
Fang Liu
Fang Liu
Yuhua Shi
Liqiang Gu
Xiaobo Lin
Jiahong Wang
Ying Chen
Yunxiang Chen
Xin Pan
Feifei Wu
Ruolang Pan
Jinfeng Liang
Lijiang Zhang
Lijiang Zhang
Repeat-dose toxicity of human umbilical cord mesenchymal stem cells via subcutaneous injection in NOG mice
Frontiers in Cell and Developmental Biology
human umbilical cord mesenchymal stem cells
subcutaneous injection
toxicity assessment
NOG mice
foamy cells
title Repeat-dose toxicity of human umbilical cord mesenchymal stem cells via subcutaneous injection in NOG mice
title_full Repeat-dose toxicity of human umbilical cord mesenchymal stem cells via subcutaneous injection in NOG mice
title_fullStr Repeat-dose toxicity of human umbilical cord mesenchymal stem cells via subcutaneous injection in NOG mice
title_full_unstemmed Repeat-dose toxicity of human umbilical cord mesenchymal stem cells via subcutaneous injection in NOG mice
title_short Repeat-dose toxicity of human umbilical cord mesenchymal stem cells via subcutaneous injection in NOG mice
title_sort repeat dose toxicity of human umbilical cord mesenchymal stem cells via subcutaneous injection in nog mice
topic human umbilical cord mesenchymal stem cells
subcutaneous injection
toxicity assessment
NOG mice
foamy cells
url https://www.frontiersin.org/articles/10.3389/fcell.2025.1558310/full
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