The Quality Evaluation System Establishment of Mesenchymal Stromal Cells for Cell-based Therapy Products

Overview

Journal Stem Cell Res Ther

Publisher Biomed Central

Date 2020 May 15

PMID 32404162

Citations 15

Authors

Yuanyuan Xie

Wei Liu

Shuo Liu

Liudi Wang

Dan Mu

Yi Cui

Yanyan Cui

Bin Wang

Affiliations

Soon will be listed here.

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 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.

Citing Articles

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PMID: 39721037 PMC: 11884619. DOI: 10.1002/advs.202406822.

Human umbilical cord mesenchymal stem cells toxicity and allergy effects: In vivo assessment.

Cheng W, Bin L, Lin Z, Yu D, Xiang D, Lo S PLoS One. 2024; 19(10):e0309429.

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Xu C, Xie Y, Wang B Stem Cell Res Ther. 2024; 15(1):323.

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Therapeutic role of extracellular vesicles from human umbilical cord mesenchymal stem cells and their wide therapeutic implications in inflammatory bowel disease and other inflammatory disorder.

Azhar Ud Din M, Wan A, Chu Y, Zhou J, Yan Y, Xu Z Front Med (Lausanne). 2024; 11:1406547.

PMID: 39139783 PMC: 11319305. DOI: 10.3389/fmed.2024.1406547.

Combinatorial intervention with dental pulp stem cells and sulfasalazine in a rat model of ulcerative colitis.

Aly R, Abohashem R, Ahmed H, Halim A Inflammopharmacology. 2024; 32(6):3863-3879.

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