Screening of cell preparation protective agent and its effect on preparation safety and efficacy
10.13200/j.cnki.cjb.004559
- VernacularTitle:细胞制剂保护液的筛选及其对制剂安全性和有效性的影响
- Author:
LIANG Xiao
- Publication Type:Journal Article
- Keywords:
Human umbilical cord mesenchymal stem cells(hUC-MSCs);
Cytokine-induced killer cells(CIKs);
Cell preparation protective agent;
Compound electrolyte injection;
Human serum albumin(HSA)
- From:
Chinese Journal of Biologicals
2025;38(09):1049-1055
- CountryChina
- Language:Chinese
-
Abstract:
Objective To screen the protective agent for the preparations of human umbilical cord mesenchymal stem cells(hUC-MSCs) and cytokine-induced killer cells(CIKs), and to explore its effect on the safety and efficacy of the preparations,so as to provide safe and efficient cell preparations for cell therapy.Methods Eight formulations with or without 1% human serum albumin(HSA), 5% HSA and 40 mmol/L trehalose(group A-H) were designed using compound electrolyte injection,0. 9% sodium chloride injection and lactated Ringer's injection as the base solution. The hUC-MSCs and CIK cells were separately mixed with eight kinds of protective agents to prepare corresponding cell preparations. The cell viability, apoptosis and phenotypic changes of the two sets of cell preparations at different time points within 24 h were assessed, and the optimal cell preparation protective agent was screened out. Further exploration was conducted to investigate the safety and efficacy of the formulation.Results The addition of HSA could delay the decline in cell viability, slowed down the apoptosis and improve the stability of cell preparations, but the increase of HSA concentration could not further improve the protective effect. The cell viability of hUC-MSCs and CIK cells prepared in group A(compound electrolyte injection with 1% HSA) was all within the qualified range within 24 h, and the apoptosis rates were the lowest, so group A was determined as the optimum protective agent. There was no significant difference in the expression levels of surface markers within 24 h in hUC-MSCs and CIK cells prepared with eight protective agents(F = 0. 78 and 0. 99 respectively, each P > 0. 05). The endotoxin content,osmotic pressure, karyotype analysis and abnormal toxicity test of the cell preparations prepared by group A protective agent all met the safety standards. The hUC-MSCs cell preparation could maintain the ability of immune regulation and multi-directional differentiation, and the CIK cell preparation had strong tumor killing activity in vitro.Conclusion Compound electrolyte injection with 1% HSA is an effective protective agent for cell preparations, which can meet the requirements for the preparation and short-term preservation of hUC-MSCs and CIK cell preparations
