ArticleStem cell research & therapy2020
The quality evaluation system establishment of mesenchymal stromal cells for cell-based therapy products.
Article in Stem cell research & therapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.
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Who cites it
24 citing papers in PubMed.
- A first-in-human, prospective pilot trial of umbilical cord-derived mesenchymal stem cell eye drops therapy for patients with refractory non-Sjögren's and Sjögren's syndrome dry eye disease.Stem cell research & therapy · 2025Trial
- Genetically Modified MSCs for Targeted Regeneration: Balancing Efficacy, Biosafety, and GMP Standardization.Cells · 2026Review
- Clinical translational research on stem cell products: prospects and challenges.Signal transduction and targeted therapy · 2026Review
- Immunomodulatory role of decellularized extracellular matrix in skin wound healing.Materials today. Bio · 2026Review
- Immunomodulatory properties of umbilical cord mesenchymal stromal cells in immune disorders: immunoregulatory functions, therapeutic progress, and engineering strategies for enhanced efficacy.Frontiers in immunology · 2026Review
- Standard Methods for Quality Control in Cell-Based Medicinal Products and their Validation for Clinical Applications.Advanced biomedical research · 2026Review
- Therapeutic Potential of Chimeric Antigen Receptor-Expressing Mesenchymal Stem Cells in the Treatment of Inflammatory and Autoimmune Diseases.International journal of molecular sciences · 2025Review
- The therapeutic efficacy comparison of MSCs derived different tissues unveilings anti-apoptosis more crucial than angiogenesis in treating acute myocardial infarction.Stem cell research & therapy · 2025Article
- Identifying TNFSF4Stem cell research & therapy · 2025Article
- ShK-modified UCMSCs Inhibit M1-Like Macrophage Polarization and Alleviate Osteoarthritis Progression via PI3K/Akt Axis.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025Article
- Genetically modified mesenchymal stromal cells: a cell-based therapy offering more efficient repair after myocardial infarction.Stem cell research & therapy · 2024Review
- Noninvasive total counting of cultured cells using a home-use scanner with a pattern sheet.iScience · 2024Article
- Human umbilical cord mesenchymal stem cells toxicity and allergy effects: In vivo assessment.PloS one · 2024Article
- 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.Frontiers in medicine · 2024Review
- Oral administration of Bifidobacterium breve improves anti-angiogenic drugs-derived oral mucosal wound healing impairment via upregulation of interleukin-10.International journal of oral science · 2023Article
- Comparison of therapeutic effects of mesenchymal stem cells from umbilical cord and bone marrow in the treatment of type 1 diabetes.Stem cell research & therapy · 2022Article
- Manufacturing clinical-grade human induced pluripotent stem cell-derived beta cells for diabetes treatment.Cell proliferation · 2022Review
- A long-term anti-inflammation markedly alleviated high-fat diet-induced obesity by repeated administrations of overexpressing IL10 human umbilical cord-derived mesenchymal stromal cells.Stem cell research & therapy · 2022Article
- Interleukin-10 genetically modified clinical-grade mesenchymal stromal cells markedly reinforced functional recovery after spinal cord injury via directing alternative activation of macrophages.Cellular & molecular biology letters · 2022Article
- Aging conundrum: A perspective for ovarian aging.Frontiers in endocrinology · 2022Review
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCell-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.
methodsIn 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.
resultsThe 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.
conclusionIn 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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