The quality evaluation system establishment of mesenchymal stromal cells for cell-based therapy products.

ABSTRACT:

Background

Cell-based therapy products are supposed to be the most complex medicine products in the history of human medical care. In this study, we established a safety evaluation system for therapeutic stromal cells based on the existing regulations and current testing techniques to provide general quality requirements for human umbilical cord mesenchymal stromal cell (HUCMSC) therapy product.

Methods

In this system, we comprehensively evaluate the environmental monitoring program, quality control of critical raw materials and reagents, donor screening criteria, cell safety, quality, and biological effects, not only in line with the basic criteria of biological products, but also following the general requirements of drugs.

Results

The qualified HUCMSCs were tested

SUBMITTER: Xie Y 

PROVIDER: S-EPMC7222464 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature