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

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 gener...

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Autores principales: Xie, Yuanyuan, Liu, Wei, Liu, Shuo, Wang, Liudi, Mu, Dan, Cui, Yi, Cui, Yanyan, Wang, Bin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2020
Materias:
Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7222464/
https://www.ncbi.nlm.nih.gov/pubmed/32404162
http://dx.doi.org/10.1186/s13287-020-01696-6
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author Xie, Yuanyuan
Liu, Wei
Liu, Shuo
Wang, Liudi
Mu, Dan
Cui, Yi
Cui, Yanyan
Wang, Bin
author_facet Xie, Yuanyuan
Liu, Wei
Liu, Shuo
Wang, Liudi
Mu, Dan
Cui, Yi
Cui, Yanyan
Wang, Bin
author_sort Xie, Yuanyuan
collection PubMed
description 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 for various clinical researches in our hospital, and no severe adverse reaction was observed in 225 patients during a 1-year follow-up period. CONCLUSION: In this study, we establish a systemic quality control and potent assays to guarantee the safety and effectiveness of HUCMSCs based on a minimum set of standards in MSC-based product.
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spelling pubmed-72224642020-05-20 The quality evaluation system establishment of mesenchymal stromal cells for cell-based therapy products Xie, Yuanyuan Liu, Wei Liu, Shuo Wang, Liudi Mu, Dan Cui, Yi Cui, Yanyan Wang, Bin Stem Cell Res Ther Research 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 for various clinical researches in our hospital, and no severe adverse reaction was observed in 225 patients during a 1-year follow-up period. CONCLUSION: In this study, we establish a systemic quality control and potent assays to guarantee the safety and effectiveness of HUCMSCs based on a minimum set of standards in MSC-based product. BioMed Central 2020-05-13 /pmc/articles/PMC7222464/ /pubmed/32404162 http://dx.doi.org/10.1186/s13287-020-01696-6 Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Xie, Yuanyuan
Liu, Wei
Liu, Shuo
Wang, Liudi
Mu, Dan
Cui, Yi
Cui, Yanyan
Wang, Bin
The quality evaluation system establishment of mesenchymal stromal cells for cell-based therapy products
title The quality evaluation system establishment of mesenchymal stromal cells for cell-based therapy products
title_full The quality evaluation system establishment of mesenchymal stromal cells for cell-based therapy products
title_fullStr The quality evaluation system establishment of mesenchymal stromal cells for cell-based therapy products
title_full_unstemmed The quality evaluation system establishment of mesenchymal stromal cells for cell-based therapy products
title_short The quality evaluation system establishment of mesenchymal stromal cells for cell-based therapy products
title_sort quality evaluation system establishment of mesenchymal stromal cells for cell-based therapy products
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7222464/
https://www.ncbi.nlm.nih.gov/pubmed/32404162
http://dx.doi.org/10.1186/s13287-020-01696-6
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