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Clinical Trial
. 2022 May 3;13(1):180.
doi: 10.1186/s13287-022-02848-6.

Efficacy and safety of umbilical cord-derived mesenchymal stem cells in Chinese adults with type 2 diabetes: a single-center, double-blinded, randomized, placebo-controlled phase II trial

Li Zang #  1 , Yijun Li #  1 , Haojie Hao  2 , Jiejie Liu  2 , Yu Cheng  1 , Bing Li  1 , Yaqi Yin  1 , Qian Zhang  1 , Fei Gao  1 , Haibin Wang  1 , Shi Gu  1 , Jia Li  1 , Fengxiang Lin  1 , Yingfei Zhu  1 , Guanglei Tian  1 , Yulong Chen  1 , Weijun Gu  1 , Jin Du  1 , Kang Chen  1 , Qinghua Guo  1 , Guoqing Yang  1 , Yu Pei  1 , Wenhua Yan  1 , Xianling Wang  1 , Junhua Meng  1 , Saichun Zhang  1 , Jianming Ba  1 , Zhaohui Lyu  1 , Jingtao Dou  1 , Weidong Han  3 , Yiming Mu  4
Affiliations
Clinical Trial

Efficacy and safety of umbilical cord-derived mesenchymal stem cells in Chinese adults with type 2 diabetes: a single-center, double-blinded, randomized, placebo-controlled phase II trial

Li Zang et al. Stem Cell Res Ther. .

Abstract

Background: To determine the efficacy and safety of umbilical cord-derived mesenchymal stem cells (UC-MSCs) in Chinese adults with type 2 diabetes mellitus (T2DM).

Methods: In this single-center, double-blinded, randomized, placebo-controlled phase II trial, 91 patients were randomly assigned to receive intravenous infusion of UC-MSCs (n = 45) or placebo (n = 46) three times with 4-week intervals and followed up for 48 weeks from October 2015 to December 2018. The primary endpoint was the percentage of patients with glycated hemoglobin (HbA1c) levels of < 7.0% and daily insulin reduction of ≥ 50% at 48 weeks. Additional endpoints were changes of metabolic control, islet β-cell function, insulin resistance, and safety.

Results: At 48 weeks, 20% of the patients in the UC-MSCs group and 4.55% in the placebo group reached the primary endpoint (p < 0.05, 95% confidence interval (CI) 2.25-28.66%). The percentage of insulin reduction of the UC-MSCs group was significantly higher than that of the placebo group (27.78% versus 15.62%, p < 0.05). The levels of HbA1c decreased 1.31% (9.02 ± 1.27% to 7.52 ± 1.07%, p < 0.01) in the UC-MSCs group, and only 0.63% in the placebo group (8.89 ± 1.11% to 8.19 ± 1.02%, p˃0.05; p = 0.0081 between both groups). The glucose infusion rate (GIR) increased significantly in the UC-MSCs group (from 3.12 to 4.76 mg/min/kg, p < 0.01), whereas no significant change was observed in the placebo group (from 3.26 to 3.60 mg/min/kg, p ˃ 0.05; p < 0.01 between both groups). There was no improvement in islet β-cell function in both groups. No major UC-MSCs transplantation-related adverse events occurred.

Conclusions: UC-MSCs transplantation could be a potential therapeutic approach for Chinese adults with T2DM. Trial registration This study was registered on ClinicalTrials.gov (identifier: NCT02302599).

Keywords: Glycated hemoglobin A1c; Insulin resistance; Islet β-cell function; Type 2 diabetes mellitus; Umbilical cord-derived mesenchymal stem cells.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flowchart of the study. UC-MSCs, umbilical cord mesenchymal stem cells
Fig. 2
Fig. 2
Insulin requirement and HbA1c levels after treatment with UC-MSCs or placebo. *p < 0.05, **p < 0.01, ***p < 0.001 between both groups. HbA1c, glycated hemoglobin A1c
Fig. 3
Fig. 3
Islet β-cell function and insulin resistance after treatment with UC-MSCs or placebo. *p < 0.05, **p < 0.01, ***p < 0.001 between both groups; #p < 0.05; ## p < 0.01; ###p < 0.001 versus baseline values. GIR, glucose infusion rate
See this image and copyright information in PMC

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