ArticleInternational journal of nanomedicine2025
Quality Control of Fetal Wharton's Jelly Mesenchymal Stem Cells-Derived Small Extracellular Vesicles.
Article in International journal of nanomedicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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Who cites it
5 citing papers in PubMed.
- Beyond Passage Numbers: How Culture Conditions and Population-Doubling Metrics Reporting Shape the Quality of Umbilical Cord-Derived MSCs and Extracellular Vesicles.International journal of molecular sciences · 2026Review
- Extracellular vesicle-mediated immunomodulation and targeted delivery: breakthroughs and challenges in rheumatoid arthritis therapy.Frontiers in immunology · 2026Review
- Protocol Optimization for Exosome Production From Umbilical Cord Mesenchymal Stem Cells: A Step Toward Clinical Translation.Basic and clinical neuroscience · 2025Article
- Resveratrol Improves Cognitive Function in Sleep-Deprived Mice by Inhibiting p38 MAPK Signaling Pathway.Food science & nutrition · 2025Article
- Safety Evaluation and Biodistribution of Fetal Umbilical Cord Mesenchymal Stem Cells-Derived Small Extracellular Vesicles in Sprague Dawley Rats.International journal of molecular sciences · 2025Article
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Quality control (QC) is an important element in ensuring drug substances' safety, efficacy, and quality. The dosing regimen for sEVs can be in the form of protein concentration or the number of particles based on the results of a series of quality controls applied as in-process control. Methods: Wharton's Jelly Mesenchymal Stem Cells (WJMSCs) were isolated from four independent umbilical cord samples and were characterized following the International Society for Cellular Therapy (ISCT) guidelines. Small extracellular vesicles (sEVs) were isolated separately from these four WJMSCs samples using the Tangential Flow Filtration (TFF) method and were characterized per Minimal Information for Studies of Extracellular Vesicles (MISEV2018) guidelines. Each isolated and concentrated sEV preparation was standardized and its purity was determined by the ratio of the number of particles to protein concentration. Results: All the WJMSCs samples passed the Mesenchymal Stem Cells (MSCs) characterization QC tests. Qualitatively, EVs-positive markers (CD63 and TSG101) and intact bilipid membrane vesicles were detected in all the sEV preparations. Quantitatively, the protein and particle concentrations revealed that all the sEV preparations were "impure" with < 1.5 × 10 Conclusion: In short, all characterized and standardized individual and pooled sEV preparations were deemed "impure" due to albumin co-isolation using the TFF method. For therapeutic development, it is essential to report protein and particle concentrations in EV preparations based on these QC results.
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