Characterization of dynamical changes in vital signs during allogeneic human umbilical cord-derived mesenchymal stem cells infusion

Yue Wang; Haiping Yu; Hongming Tang; Rong Zhu; Yiqi Shi; Changqin Xu; Yan Li; Hua Wang; Yuanyuan Chen; Peichen Shen; Jinfang Xu; Congrong Wang; Zhongmin Liu

doi:10.1016/j.reth.2023.07.007

Characterization of dynamical changes in vital signs during allogeneic human umbilical cord-derived mesenchymal stem cells infusion

Regen Ther. 2023 Aug 2:24:282-287. doi: 10.1016/j.reth.2023.07.007. eCollection 2023 Dec.

Authors

Yue Wang¹, Haiping Yu², Hongming Tang^{1

3}, Rong Zhu¹, Yiqi Shi¹, Changqin Xu¹, Yan Li¹, Hua Wang⁴, Yuanyuan Chen³, Peichen Shen⁵, Jinfang Xu⁶, Congrong Wang⁷, Zhongmin Liu^{1

3}

Affiliations

¹ Clinical Research Center for Cell Therapy, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai 200120, China.
² Nursing Department, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai 200120, China.
³ Translational Medical Center for Stem Cell Therapy, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai 200120, China.
⁴ Catheterization Room, Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine, Shanghai 200137, China.
⁵ Department of Medicine, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai 200120, China.
⁶ Department of Health Statistics, Second Military Medical University, Shanghai 200433, China.
⁷ Department of Endocrinology & Metabolism, Shanghai Fourth People's Hospital, School of Medicine, Tongji University, Shanghai 200434, China.

Abstract

Human umbilical cord-derived mesenchymal stem cells (hUC-MSCs), a kind of adult stem cell, were studied for clinical applications in regenerative medicine. To date, the safety evaluations of intravenous infusion of allogeneic hUC-MSCs were focused on fever, infection, malignancy, and death. However, the characteristics of dynamical changes in vital signs during hUC-MSCs infusion are largely unknown. In this study, twenty participants with allogeneic hUC-MSCs transplanted (MSC group) and twenty sex- and age-matched individuals with cardiovascular disease who treated with the equal volume of 0.9% normal saline were recruited (NS group). Heart rate, respiratory rate, oxygen saturation, systolic and diastolic blood pressure, and temperature were monitored at intervals of 15 min during infusion. Adverse events were recorded during infusion and within seven days after infusion. No adverse events were observed during and after infusion in both groups. Compared with the baseline, the mean systolic blood pressure (SBP) levels were significantly decreased at 15 min, 30 min, 45 min and 60 min in the MSC group (all P < 0.05) during infusion. In addition, SBP changed significantly from baseline during hUC-MSCs infusion when compared with that of NS group (P < 0.05). Repeated measures analysis of variance confirmed difference over time on the SBP levels (P < 0.05). Our results showed that the process of allogeneic hUC-MSCs intravenous infusion was safe and the vital signs were stable, whereas a slight decrease in SBP was observed.

Keywords: Allogeneic; Human umbilical cord; Infusion; Mesenchymal stem cells; Vital signs.