Evaluation method for acute toxicity of mesenchymal stem cell preparation and application

An evaluation method and stem cell technology, applied in the biological field, can solve problems such as lack of technical means for acute toxicity, and achieve the effect of reducing the risk of inaccurate results and avoiding inaccurate evaluation results.

Inactive Publication Date: 2019-03-08
TIANJIN CHANGHE BIOLOGICAL TECH
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  • Summary
  • Abstract
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  • Claims
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Problems solved by technology

The preclinical safety evaluation of mesenchymal stem cells, especially the evaluation of acute toxicity, lacks corresponding technical means

Method used

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  • Evaluation method for acute toxicity of mesenchymal stem cell preparation and application
  • Evaluation method for acute toxicity of mesenchymal stem cell preparation and application
  • Evaluation method for acute toxicity of mesenchymal stem cell preparation and application

Examples

Experimental program
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Embodiment

[0067] This example provides a method for evaluating the acute toxicity of human umbilical cord mesenchymal stem cells.

[0068] experimental design:

[0069] (1) Group setting: The experiment set up 3 groups: 1 blank control group and 2 dosing groups. The dosing groups include the first dose group and the second dose group, each with 20 mice, half male and half.

[0070] (2) Metering design and basis: In the proposed clinical plan, the human dose is intravenously 6.0×10 7 cells / 100ml / person, converted into a clinical preparation concentration of 6.0×10 5 cells / ml, the clinical dose is 1.0×10 6 cells / kg (60kg for humans), 20g for mice, the clinical equivalent dose is 1.3×10 7 cells / kg.

[0071] In this embodiment, there are two administration groups, the first dose group and the second dose group.

[0072] The dose of the first dose group is 1.51×10 7 cells / kg, the drug concentration is 6.05×10 5 cells / ml, the administration volume is 25ml / kg, the dose of the first dose group is slightl...

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Abstract

The invention provides an evaluation method for acute toxicity of a mesenchymal stem cell preparation and application, and relates to the technical field of biology. The evaluation method comprises the steps of providing tested animals which are administrated with the mesenchymal stem cell preparation, and then detecting physiological statuses of the tested animals. The tested animals which are administrated with the mesenchymal stem cell preparation at least comprise a group of tested animals which are administrated with the mesenchymal stem cell preparation in a first dosage and a group of tested animals which are administrated with the mesenchymal stem cell preparation in a second dosage; the administration dosage of the group of tested animals which are administrated with the mesenchymal stem cell preparation in the first dosage is 0.8-1.5 times the clinical equivalent dosage; and the administration dosage of the group of tested animals which are administrated with the mesenchymalstem cell preparation in the second dosage is 3-5 times the clinical equivalent dosage. By the evaluation method, the technical problem that in the prior art, effective evaluation on the acute toxicity of the mesenchymal stem cell preparation does not exist is solved, safe data are provided for clinical test of the mesenchymal stem cell preparation and design of other safety research, and reference is provided for clinical safe medication.

Description

Technical field [0001] The invention relates to the field of biotechnology, in particular to a method and application for evaluating the acute toxicity of a mesenchymal stem cell preparation. Background technique [0002] Mesenchymal stem cells are derived from the mesoderm and ectoderm in the early stages of development. They are pluripotent stem cells. They have attracted increasing attention because of their multi-directional differentiation potential, hematopoietic support and promotion of stem cell implantation, immune regulation and self-replication. Mesenchymal stem cells can differentiate into adipose, bone, cartilage, nerve, endothelium and other tissue cells under specific induction conditions in vivo or in vitro. After continuous subculture and cryopreservation, they still have multidirectional differentiation potential and can be used as ideal Seed cells are used to repair tissue and organ damage caused by aging and disease. [0003] Mesenchymal stem cells are said to ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K35/28A61K49/00
CPCA61K35/28A61K49/0004
Inventor 牟春琳李伟徐永胜李政楠
Owner TIANJIN CHANGHE BIOLOGICAL TECH
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