ArticleStem cell research & therapy2025
Continuous collection of human mesenchymal-stromal-cell-derived extracellular vesicles from a stirred tank reactor operated under xenogeneic-free conditions for therapeutic applications.
Article in Stem cell research & therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.
What it found
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Who cites it
22 citing papers in PubMed.
- The dual role of exosomes in renal fibrosis and their potential for clinical translational applications.Renal failure · 2026Review
- Towards a Scalable Production ofInternational journal of molecular sciences · 2026Article
- Extracellular Vesicles in Wearable Delivery Systems for Cosmeceutical Applications.Advanced healthcare materials · 2026Review
- 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
- A review of recent advances in exosome-mediated drug delivery for regenerative therapy and immunomodulation.Biomedical engineering online · 2026Review
- Beyond Extracellular Vesicle (EV) Hype: Practical Solutions and Remaining Hurdles in EV Research, Manufacturing, and Clinical Translation.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Review
- Mesenchymal stem cell-derived extracellular vesicle therapy in breast cancer: A systematic review and meta-analysis ofMolecular therapy. Oncology · 2026Review
- Bioreactors expansion of human mesenchymal stromal cell therapies: platforms, parameters, challenges and opportunities.Journal, genetic engineering & biotechnology · 2026Review
- Bioreactor expansion of human neural progenitor cells for exosome scalable production and miRNA-engineering.Journal of biological engineering · 2026Article
- Exosomes as mediators of repair and immunoregulation in multiple sclerosis: a new frontier in cell-free therapy.Molecular biology reports · 2026Review
- Molecular pathways and immune microenvironment regulation in stem cell therapy for thin endometrium: a comprehensive narrative review.Frontiers in immunology · 2026Review
- Biologic and regenerative strategies for osteoarthritis: advances in MSC, exosome, and PRP based therapies.Frontiers in pharmacology · 2026Review
- Extracellular vesicle therapeutics in Alzheimer's disease: mechanisms, progress, and prospects.Extracellular vesicles and circulating nucleic acids · 2026Review
- Optimizing Extracellular Vesicles for Cardiac Repair Post-Myocardial Infarction: Approaches and Challenges.Biomolecules · 2025Review
- Unveiling Exosomes and Microvesicles in Parkinson's Disease: Mechanistic Insights Into Cell Death Pathways and Therapeutic Potential.Molecular neurobiology · 2025Review
- Advances of extracellular vesicles isolation and detection frontier technology: from heterogeneity analysis to clinical application.Journal of nanobiotechnology · 2025Review
- Mesenchymal stem cell therapies for ARDS: translational promise and challenges.Stem cell research & therapy · 2025Review
- Emerging Strategies for Cargo Loading and Engineering of Extracellular Vesicles for Breast Cancer Treatment.Nanomaterials (Basel, Switzerland) · 2025Review
- Exploring the therapeutic potential of MSC-derived secretomes in neonatal care: focus on BPD and NEC.Stem cell research & therapy · 2025Review
- Review
Corrections and comments
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Authors and funding
11 authors.
Funding
Abstract
backgroundMesenchymal-stromal-cell-derived extracellular vesicles (MSC-EVs) play a key role in the paracrine effects of MSC and have demonstrated therapeutic potential in various preclinical models. However, clinical translation is hindered by manufacturing practices relying on planar culture systems, fetal bovine serum (FBS)-supplemented media, and non-scalable, low-purity EV isolation methods that fail to meet dose and safety requirements, underscoring the need for innovative approaches. In this study, we developed a scalable platform to manufacture human MSC-EVs at clinically relevant numbers, integrating continuous collection of EV-enriched conditioned media (CM) using a stirred-tank reactor (STR) under xenogeneic-free conditions and a scalable downstream process.
methodsWharton's jelly-derived MSC (MSC(WJ)) were expanded using microcarriers in a controlled STR using human platelet lysate (hPL)-supplemented medium. Then, a 3-day EV production stage, featuring continuous harvesting of the CM, was established using a novel serum-/xeno(geneic)-free exosome depleted-hPL supplement. For the isolation of MSC-EVs, a scalable process was implemented by pairing tangential flow filtration and anion exchange chromatography. Isolated MSC-EVs were characterised using nanoparticle tracking analysis, protein and zeta potential quantification, western blot analysis of EV protein markers, transmission electron microscopy and uptake studies of fluorescently labelled-EVs.
resultsThe system sustained the efficient expansion of MSC(WJ), reaching a total of (6.03 ± 0.181) x 10
conclusionsOverall, the scalable and Good Manufacturing Practices (GMP)-compliant platform established herein enabled the reproducible manufacturing of MSC-EVs with high purity and generally accepted characteristics concerning size, protein markers, surface charge, morphology, and cellular internalization, validating its potential for future clinical applications.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.